Trial Outcomes & Findings for Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment (NCT NCT03490734)
NCT ID: NCT03490734
Last Updated: 2023-04-06
Results Overview
The fMRI paradigm assesses evoked blood oxygen level dependent (BOLD) response to receipt of study beverages (sweet and unsweet) and a water solution, and logo-elicited anticipation of both beverages and water solution. The visual stimuli are two beverage logos, a water logo, and a fixation cross. Each logo (1 second) signals impending delivery of 3 mL of the associated juice/water over 6 seconds, with the fixation cross otherwise presented. A jitter ranging from 5 to 13 seconds follows each trial. In total, the participants are shown 24 repeats of the events of interest over 4, 7-minute runs. Contrasts of interest are the post- \> pre-intervention BOLD response to sweetened beverage logo \> water logo. Parameter estimates for these contrasts are extracted and reported. A positive reported outcome reflects higher post- vs. pre-intervention (negative values reflect lower post- vs. pre-intervention) change in whole-brain BOLD response for sweetened beverage logo \> water logo for each arm.
COMPLETED
NA
160 participants
Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
2023-04-06
Participant Flow
Participant milestones
| Measure |
Beverage A (Sweetened)
One quarter of the group to receive black cherry and orange flavored beverage with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage with added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage B (Sweetened)
One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Strawberry Kiwi \&Lemonade Flavored Beverage with added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage A (Unsweetened)
One quarter of the group to receive black cherry and orange flavored beverage no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage no added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage B (Unsweetened)
One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Strawberry Kiwi \& Lemonade Flavored Beverage no added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
|---|---|---|---|---|
|
Pre-intervention Baseline Visit
STARTED
|
47
|
38
|
34
|
41
|
|
Pre-intervention Baseline Visit
COMPLETED
|
47
|
38
|
34
|
41
|
|
Pre-intervention Baseline Visit
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Pre-intervention Scan Visit
STARTED
|
47
|
38
|
34
|
41
|
|
Pre-intervention Scan Visit
COMPLETED
|
45
|
37
|
34
|
37
|
|
Pre-intervention Scan Visit
NOT COMPLETED
|
2
|
1
|
0
|
4
|
|
Post-intervention Scan Visit
STARTED
|
45
|
37
|
34
|
37
|
|
Post-intervention Scan Visit
COMPLETED
|
43
|
34
|
34
|
34
|
|
Post-intervention Scan Visit
NOT COMPLETED
|
2
|
3
|
0
|
3
|
|
Post-intervention Behavioral Visit
STARTED
|
43
|
34
|
34
|
34
|
|
Post-intervention Behavioral Visit
COMPLETED
|
43
|
34
|
34
|
34
|
|
Post-intervention Behavioral Visit
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Beverage A (Sweetened)
One quarter of the group to receive black cherry and orange flavored beverage with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage with added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage B (Sweetened)
One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Strawberry Kiwi \&Lemonade Flavored Beverage with added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage A (Unsweetened)
One quarter of the group to receive black cherry and orange flavored beverage no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage no added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage B (Unsweetened)
One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Strawberry Kiwi \& Lemonade Flavored Beverage no added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
|---|---|---|---|---|
|
Pre-intervention Scan Visit
fMRI contraindications
|
2
|
1
|
0
|
2
|
|
Pre-intervention Scan Visit
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Pre-intervention Scan Visit
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Post-intervention Scan Visit
Adverse Event
|
2
|
0
|
0
|
0
|
|
Post-intervention Scan Visit
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Post-intervention Scan Visit
Withdrawal by Subject
|
0
|
2
|
0
|
3
|
Baseline Characteristics
Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment
Baseline characteristics by cohort
| Measure |
Beverage A (Sweetened)
n=47 Participants
One quarter of the group to receive black cherry and orange flavored beverage with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage with added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage B (Sweetened)
n=38 Participants
One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Strawberry Kiwi \&Lemonade Flavored Beverage with added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage A (Unsweetened)
n=34 Participants
One quarter of the group to receive black cherry and orange flavored beverage no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage no added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage B (Unsweetened)
n=41 Participants
One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Strawberry Kiwi \& Lemonade Flavored Beverage no added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
21.9 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
21.4 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
21.9 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
21.3 years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
21.6 years
STANDARD_DEVIATION 2.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
23.4 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
23.1 kg/m^2
STANDARD_DEVIATION 2.7 • n=7 Participants
|
23.9 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
22.7 kg/m^2
STANDARD_DEVIATION 3.0 • n=4 Participants
|
23.2 kg/m^2
STANDARD_DEVIATION 3.2 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentPopulation: Decrease in the sample was due to missing data and/or errors in neuroimaging data processing. For results reporting, the two types of flavored beverages (strawberry, kiwi \& lemonade OR black cherry \& orange) were combined based on sweetness (sweetened vs. unsweetened beverage) resulting in two arms. We combined beverages across flavors, since the main outcome of interest is the effect of sugar in beverages independent of flavor.
The fMRI paradigm assesses evoked blood oxygen level dependent (BOLD) response to receipt of study beverages (sweet and unsweet) and a water solution, and logo-elicited anticipation of both beverages and water solution. The visual stimuli are two beverage logos, a water logo, and a fixation cross. Each logo (1 second) signals impending delivery of 3 mL of the associated juice/water over 6 seconds, with the fixation cross otherwise presented. A jitter ranging from 5 to 13 seconds follows each trial. In total, the participants are shown 24 repeats of the events of interest over 4, 7-minute runs. Contrasts of interest are the post- \> pre-intervention BOLD response to sweetened beverage logo \> water logo. Parameter estimates for these contrasts are extracted and reported. A positive reported outcome reflects higher post- vs. pre-intervention (negative values reflect lower post- vs. pre-intervention) change in whole-brain BOLD response for sweetened beverage logo \> water logo for each arm.
Outcome measures
| Measure |
Beverages A (Sweetened) and B (Sweetened)
n=64 Participants
Half of the group to receive a flavored beverage (strawberry, kiwi \& lemonade flavored OR black cherry \& orange flavored) with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage with added sugar: 10 oz daily for three weeks OR Strawberry Kiwi \&Lemonade Flavored Beverage with added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverages A (Unsweetened) and B (Unsweetened)
n=58 Participants
Half of the group to receive a flavored beverage (strawberry, kiwi \& lemonade flavored OR black cherry \& orange flavored) no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage no added sugar: 10 oz daily for three weeks OR Strawberry Kiwi \&Lemonade Flavored Beverage no added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
|---|---|---|
|
Change in Voxel-wise Blood Oxygen Level Dependent (BOLD) Including Outliers Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo
|
-2.69 arbitrary units
Standard Deviation 13.52
|
-3.06 arbitrary units
Standard Deviation 14.89
|
SECONDARY outcome
Timeframe: Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentPopulation: Decrease in the sample was due to missing data and/or errors in neuroimaging data processing. For results reporting, the two types of flavored beverages (strawberry, kiwi \& lemonade OR black cherry \& orange) were combined based on sweetness (sweetened vs. unsweetened beverage) resulting in two arms. We combined beverages across flavors, since the main outcome of interest is the effect of sugar in beverages independent of flavor.
The fMRI paradigm assesses evoked blood oxygen level dependent (BOLD) response to receipt of study beverages, (sweetened and unsweetened) and a water solution, and logo-elicited anticipation of both beverages and water solution. Whole-brain analyses are performed. Contrasts of interest for the within-subject models are post-intervention \> pre-intervention BOLD response to beverage vs. water logo and contrasts of interest for the group model are sweetened beverage logo \> water logo. To test the interaction of brain activation with BMI, BMI is entered as a covariate in the group model. Parameter estimates of significant BOLD response to these contrasts are extracted and reported. A positive reported outcome reflects higher post- vs. pre-intervention (negative values reflect lower post- vs. pre-intervention) change in BOLD response in the putamen for the sweetened beverage logo \> water logo for each arm.
Outcome measures
| Measure |
Beverages A (Sweetened) and B (Sweetened)
n=64 Participants
Half of the group to receive a flavored beverage (strawberry, kiwi \& lemonade flavored OR black cherry \& orange flavored) with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage with added sugar: 10 oz daily for three weeks OR Strawberry Kiwi \&Lemonade Flavored Beverage with added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverages A (Unsweetened) and B (Unsweetened)
n=58 Participants
Half of the group to receive a flavored beverage (strawberry, kiwi \& lemonade flavored OR black cherry \& orange flavored) no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage no added sugar: 10 oz daily for three weeks OR Strawberry Kiwi \&Lemonade Flavored Beverage no added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
|---|---|---|
|
Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Beverage Taste and Logo by Body Mass Index (BMI)
|
3.47 arbitrary units
Standard Deviation 204.99
|
-9.82 arbitrary units
Standard Deviation 198.96
|
SECONDARY outcome
Timeframe: Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention AssessmentPopulation: Decrease in the sample was due to missing data. For results reporting, the two types of flavored beverages (strawberry, kiwi \& lemonade OR black cherry \& orange) were combined based on sweetness (sweetened vs. unsweetened beverage) resulting in two arms. We combined beverages across flavors, since the main outcome of interest is the effect of sugar in beverages independent of flavor.
Perceptual ratings of the assigned beverage using visual analog scales are assessed at the pre- and post-intervention behavioral visits. Visual analog scales (VAS) are presented on an iPad screen. The scale assesses response to taste after the participant consumes a small amount of the beverage. Perceived pleasantness of, and desire to consume the two beverages is measured using adapted labeled hedonic scales at pre-/post-intervention. Pleasantness is phrased 'How pleasant is this taste' and anchored by (-100) 'most unpleasant imaginable' to (100) 'most pleasant imaginable', and 'neutral' (0) in the middle. Desire follows a similar pattern using 'desire to consume' as the phrasing. Pleasantness and desire of the assigned beverage is also evaluated at the 9 intervention assessments. Higher scores represent higher pleasantness and desire.
Outcome measures
| Measure |
Beverages A (Sweetened) and B (Sweetened)
n=64 Participants
Half of the group to receive a flavored beverage (strawberry, kiwi \& lemonade flavored OR black cherry \& orange flavored) with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage with added sugar: 10 oz daily for three weeks OR Strawberry Kiwi \&Lemonade Flavored Beverage with added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverages A (Unsweetened) and B (Unsweetened)
n=58 Participants
Half of the group to receive a flavored beverage (strawberry, kiwi \& lemonade flavored OR black cherry \& orange flavored) no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage no added sugar: 10 oz daily for three weeks OR Strawberry Kiwi \&Lemonade Flavored Beverage no added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
|---|---|---|
|
Beverage Perceptual Ratings Using Visual Analog Scales
Post-Intervention "Pleasantness" ratings of assigned beverage
|
24.20 score on a scale
Standard Error 3.60
|
-8.84 score on a scale
Standard Error 3.80
|
|
Beverage Perceptual Ratings Using Visual Analog Scales
Pre-Intervention "Desire to consume" ratings of assigned beverage
|
20.30 score on a scale
Standard Error 3.50
|
-23.70 score on a scale
Standard Error 3.60
|
|
Beverage Perceptual Ratings Using Visual Analog Scales
Pre-Intervention "Pleasantness" ratings of assigned beverage
|
25.00 score on a scale
Standard Error 3.20
|
-21.00 score on a scale
Standard Error 3.30
|
|
Beverage Perceptual Ratings Using Visual Analog Scales
Post-Intervention "Desire to consume" ratings of assigned beverage
|
22.90 score on a scale
Standard Error 3.90
|
-12.20 score on a scale
Standard Error 4.10
|
SECONDARY outcome
Timeframe: Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention AssessmentPopulation: Missing data occurred due to errors with the stop-signal task on the ipad. For results reporting, the two types of flavored beverages (strawberry, kiwi \& lemonade OR black cherry \& orange) were combined based on sweetness (sweetened vs. unsweetened beverage) resulting in two arms. We combined beverages across flavors, since the main outcome of interest is the effect of sugar in beverages independent of flavor.
Stop-signal reaction time to assigned beverage logo are assessed at the pre- and post-intervention visits. The behavioral response inhibition task (stop-signal task) examines motor disinhibition in response to beverage logos. This allows for the assessment of bias toward the logos and is sensitive to detect changes due to the intervention. The task is performed on an iPad app where participants complete the task twice, once at the pre-intervention and once at the post-intervention behavioral visit. The task contains 6 runs, where 3 runs present the logo of the assigned beverage and the other 3 present the logo of the same-flavor unassigned beverage. Within each run of this task, 64 (20 "go") trials are presented, and participants are instructed to make a speeded response to a "go" stimulus except for trials when a "stop" signal occurs (an X presented over the logo), in which case participants are instructed to withhold their response.
Outcome measures
| Measure |
Beverages A (Sweetened) and B (Sweetened)
n=48 Participants
Half of the group to receive a flavored beverage (strawberry, kiwi \& lemonade flavored OR black cherry \& orange flavored) with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage with added sugar: 10 oz daily for three weeks OR Strawberry Kiwi \&Lemonade Flavored Beverage with added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
Beverages A (Unsweetened) and B (Unsweetened)
n=39 Participants
Half of the group to receive a flavored beverage (strawberry, kiwi \& lemonade flavored OR black cherry \& orange flavored) no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage no added sugar: 10 oz daily for three weeks OR Strawberry Kiwi \&Lemonade Flavored Beverage no added sugar: 10 oz daily for three weeks
Water Solution: Three mL administered per associated logo presentation only during MRI procedure.
|
|---|---|---|
|
Stop Signal Reaction Time to Logo as Measured by Behavioral Response Inhibition Task
Post-intervention reaction time
|
0.5013 seconds
Standard Deviation 0.0609
|
0.5360 seconds
Standard Deviation 0.1057
|
|
Stop Signal Reaction Time to Logo as Measured by Behavioral Response Inhibition Task
Pre-intervention reaction time
|
0.5321 seconds
Standard Deviation 0.0654
|
0.5452 seconds
Standard Deviation 0.0850
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentThe investigators use resting state fMRI (rsfMRI) data to assess intrinsic functional connectivity and network analyses. Functional connectivity is commonly quantified by measuring the synchronization of low-frequency BOLD fluctuations across pairs of brain regions of interest (ROIs) via correlation coefficients (see statistical analyses). rsfMRI data is acquired in one run of 7 minutes; participants are asked to remain still with their eyes open, and to fixate on the fixation cross.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentSaliva from participants is used to extract DNA using standard salting-out and solvent precipitation methods, to yield an average of 45 µg of DNA. The TaqIA (rs1800497) assays are done using a fluorogenic 5\_nuclease (Taqman, ABI) method on an ABI Prism 7000 Sequence Detection System via the allelic discrimination mode. Reactions containing 20ng of DNA are performed in 10 µl reactions with TaqMan Universal Polymerase Chain Reaction Master Mix using standard cycling conditions. Independent investigators score allele sizes; inconsistencies are reviewed and rerun when necessary. For every assay, each 96-well plate includes non-template and DNA standards of known genotype. All genotyping is performed at the UNC-CH Advanced Analytics Core
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentThe Food Frequency Questionnaire (FFQ) is a self-reported checklist of 76 foods and beverages with a frequency response section. Subjects report generally how often each item is consumed over a two-week period of time. The six possible responses are 1= never in the last two weeks, 2= 1-3 times in the last 2 weeks, 3= 4-6 times in the last 2 weeks, 4= 7-9 times in the last two weeks, 5= 10-13 times in the last 2 weeks, 6= daily or more in the last two weeks. Response information is used to estimate daily caloric intake (number of kcal) and macronutrient content (percent calories from carbohydrate/fat/protein). Food pattern is assessed as an aggregate of these measures. Changes in food pattern will be assessed as a difference from baseline to post-intervention assessment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentTo better capture variation in regular beverage intake patterns, the Beverage Intake Questionnaire is administered which queries directly about intake of all types of beverages. Similar to the Food Frequency Questionnaire, subjects report generally how often each item is consumed over a two-week period of time. The possible responses are 1= never in the last two weeks, 2= 1-3 times in the last 2 weeks, 3= 4-6 times in the last 2 weeks, 4= 7-9 times in the last two weeks, 5= 10-13 times in the last 2 weeks, 6= daily or more in the last two weeks. Responses information is used to estimate daily caloric intake from beverages (number of kcal) and macronutrient content (number of calories from carbohydrate/fat/protein). Changes in beverage intake are assessed as a difference from baseline to post-intervention assessment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentThe International Physical Activity Questionnaire (IPAQ), which has shown high test-retest reliability, assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives and estimates total physical activity in metabolic equivalent of task (MET-min/week) and time spent sitting. Changes in physical activity are assessed as a difference from pre- to post-intervention assessment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentThe Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rate the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Restrained Eating subscale consisted of 10 items and the scores range from 10 (worse outcome) to 50 (better outcome). The change is calculated as the difference between scores at Baseline and Post-Intervention Assessment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentThe Food Craving Inventory is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Subjects rate how often they have experienced a craving for each food on a 5-point frequency scale, where 1=never, 2=rarely (once or twice), 3=sometimes, 4= often, 5= always/almost every day. Food craving score is calculated as a total sum, and the change score is calculated from the difference between baseline to post-intervention assessment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentThe Power of Food scale assesses reported appetitive drive, food reward responsivity, sensitivity to food cues in the environment, and the frequency of food-related thoughts. The 21-item scale prompts subjects to rate how much they agree with statements about hedonic hunger on a 5-point scale, where 1=do not agree at all, 2=agree a little, 3=agree somewhat, 4=agree, and 5=strongly agree. The change in total PFS score will be calculated from the difference between baseline to post-intervention assessment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentThe Yale Food Addiction Scale (YFAS) is designed to identify participants who exhibit signs of possible food addiction to specific foods. The 9-item questionnaire is based on substance dependence criteria in the DSM-IV-TR, as well as on scales that are used to assess behavioral addictions. Subjects rate how often they have experienced a possible food addictive behavior on a 5-point frequency scale, where 0=never, 1=once a month, 2=2-4 times per month, 3= 2-3 times per week, 4= 4+ times per week. The change in total score is calculated from the difference between baseline to post-intervention assessment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentThe Barratt Impulsiveness Scale is one of the most commonly used self-report measures of impulsivity. This instrument comprises 15 items that assess three independent sub-dimensions of impulsivity: (a) Attention; (b) Non-planning; (c) Motor. Collectively, the three sub-dimensions represent a total impulsivity score. Items are statements about behavior and participants rate each item are scored from 1 (Rarely/Never) to 4 (Almost Always/Always). The change in total score is calculated from the difference between baseline to post-intervention assessment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentThe Sensitivity to Punishment/Sensitivity to Reward Questionnaire (SPSRQ) is a self-reported instrument that includes 48 yes/no questions divided into two subscales: Sensitivity to Reward (SR) and Sensitivity to Punishment (SP). Items statements about behavior, and participants will rate each item are scored from 1 (Definitely True) to 5 (Definitely False). The change in total score is calculated from the difference between baseline to post-intervention assessment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline AssessmentThe BIS/BAS scales are designed to assess individual differences in the sensitivity of two systems: A behavioral avoidance (or inhibition) system (BIS) and a behavioral approach system (BAS). The questionnaire includes 24 items. Items are statements about behavior and participants rate each item are scored from 1 (very true for me) to 4 (very false for me). The change in total score is calculated from the difference between baseline to post-intervention assessment.
Outcome measures
Outcome data not reported
Adverse Events
Beverage A (Sweetened)
Beverage B (Sweetened)
Beverage A (Unsweetened)
Beverage B (Unsweetened)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Beverage A (Sweetened)
n=47 participants at risk
One quarter of the group to receive black cherry and orange flavored beverage with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a tasteless beverage solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage with added sugar: 10 oz daily for three weeks
Tasteless Beverage: A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage B (Sweetened)
n=38 participants at risk
One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage with added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a tasteless beverage solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Strawberry Kiwi \&Lemonade Flavored Beverage with added sugar: 10 oz daily for three weeks
Tasteless Beverage: A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage A (Unsweetened)
n=34 participants at risk
One quarter of the group to receive black cherry and orange flavored beverage no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a tasteless beverage solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Black Cherry and Orange Flavored Beverage no added sugar: 10 oz daily for three weeks
Tasteless Beverage: A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure.
|
Beverage B (Unsweetened)
n=41 participants at risk
One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage no added sugar for 3 weeks.
MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a tasteless beverage solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.
Strawberry Kiwi \& Lemonade Flavored Beverage no added sugar: 10 oz daily for three weeks
Tasteless Beverage: A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea during fMRI scan
|
4.3%
2/47 • Number of events 2 • Adverse data were collected for the duration (beginning to end) of each of the 4 study assessments (pre-intervention baseline visit, pre-intervention scan visit, post-intervention scan visit, post-intervention behavioral visit) and for the duration of the intervention (21 days), an average of 25 days.
|
0.00%
0/38 • Adverse data were collected for the duration (beginning to end) of each of the 4 study assessments (pre-intervention baseline visit, pre-intervention scan visit, post-intervention scan visit, post-intervention behavioral visit) and for the duration of the intervention (21 days), an average of 25 days.
|
0.00%
0/34 • Adverse data were collected for the duration (beginning to end) of each of the 4 study assessments (pre-intervention baseline visit, pre-intervention scan visit, post-intervention scan visit, post-intervention behavioral visit) and for the duration of the intervention (21 days), an average of 25 days.
|
0.00%
0/41 • Adverse data were collected for the duration (beginning to end) of each of the 4 study assessments (pre-intervention baseline visit, pre-intervention scan visit, post-intervention scan visit, post-intervention behavioral visit) and for the duration of the intervention (21 days), an average of 25 days.
|
Additional Information
Kyle Burger, PhD, RD, MPH
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place