Trial Outcomes & Findings for Beverages and Societal Health (NCT NCT01295671)
NCT ID: NCT01295671
Last Updated: 2018-03-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
203 participants
Primary outcome timeframe
12 Month
Results posted on
2018-03-27
Participant Flow
Subjects were recruited from the Boston metro area via multiple recruitment methods (i.e., print media, social media) from February 2011 through October 2014.
3607 participants were initially telephone screened; 1462 were eligible after telephone screening; 407 were eligible after an Informational Visit; 222 provided informed consent; 19 withdrew or were found ineligible prior to completing baseline assessments. 203 participants completed baseline assessments and were randomized.
Participant milestones
| Measure |
Sugar-Sweetened Beverages
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
67
|
69
|
|
Overall Study
COMPLETED
|
60
|
60
|
66
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
3
|
Reasons for withdrawal
| Measure |
Sugar-Sweetened Beverages
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
Baseline Characteristics
Beverages and Societal Health
Baseline characteristics by cohort
| Measure |
Sugar-Sweetened Beverages
n=67 Participants
Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-Sweetened Beverages
n=67 Participants
Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=69 Participants
Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
25.9 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
26.7 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
28.0 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)
|
1.37 ratio of Triglycerides-to-HDL
n=5 Participants
|
1.30 ratio of Triglycerides-to-HDL
n=7 Participants
|
1.51 ratio of Triglycerides-to-HDL
n=5 Participants
|
1.37 ratio of Triglycerides-to-HDL
n=4 Participants
|
|
LDL-C
|
100 mg/dL
STANDARD_DEVIATION 27 • n=5 Participants
|
102 mg/dL
STANDARD_DEVIATION 28 • n=7 Participants
|
110 mg/dL
STANDARD_DEVIATION 33 • n=5 Participants
|
104 mg/dL
STANDARD_DEVIATION 30 • n=4 Participants
|
|
hsCRP
|
0.62 mg/L
n=5 Participants
|
0.77 mg/L
n=7 Participants
|
0.73 mg/L
n=5 Participants
|
0.69 mg/L
n=4 Participants
|
|
Fibrinogen
|
241 mg/dL
STANDARD_DEVIATION 64 • n=5 Participants
|
241 mg/dL
STANDARD_DEVIATION 74 • n=7 Participants
|
250 mg/dL
STANDARD_DEVIATION 71 • n=5 Participants
|
244 mg/dL
STANDARD_DEVIATION 70 • n=4 Participants
|
|
Uric Acid
|
5.3 mg/dL
STANDARD_DEVIATION 1.3 • n=5 Participants
|
5.2 mg/dL
STANDARD_DEVIATION 1.4 • n=7 Participants
|
5.3 mg/dL
STANDARD_DEVIATION 1.5 • n=5 Participants
|
5.3 mg/dL
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
ALT
|
14 U/L
n=5 Participants
|
18 U/L
n=7 Participants
|
16 U/L
n=5 Participants
|
16 U/L
n=4 Participants
|
|
Systolic Blood Pressure
|
108 mmHg
STANDARD_DEVIATION 9 • n=5 Participants
|
109 mmHg
STANDARD_DEVIATION 13 • n=7 Participants
|
106 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
108 mmHg
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Diastolic Blood Pressure
|
67 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
67 mmHg
STANDARD_DEVIATION 8 • n=7 Participants
|
68 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
67 mmHg
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Body Weight
|
75.5 kg
STANDARD_DEVIATION 15.6 • n=5 Participants
|
76.8 kg
STANDARD_DEVIATION 16.7 • n=7 Participants
|
77.5 kg
STANDARD_DEVIATION 16.1 • n=5 Participants
|
76.6 kg
STANDARD_DEVIATION 16.1 • n=4 Participants
|
|
Diet Quality: Sugar-Sweetened Beverage Consumption
|
1.4 Servings per day
STANDARD_DEVIATION 1.1 • n=5 Participants
|
1.5 Servings per day
STANDARD_DEVIATION 1.4 • n=7 Participants
|
1.8 Servings per day
STANDARD_DEVIATION 1.3 • n=5 Participants
|
1.6 Servings per day
STANDARD_DEVIATION 1.3 • n=4 Participants
|
|
Preference for sweet taste
|
6 Sample number
n=5 Participants
|
6 Sample number
n=7 Participants
|
7 Sample number
n=5 Participants
|
6 Sample number
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 MonthOutcome measures
| Measure |
Sugar-Sweetened Beverages
n=60 Participants
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
n=60 Participants
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=66 Participants
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)
|
1.46 ratio of Triglycerides-to-HDL
Interval 0.98 to 2.19
|
1.19 ratio of Triglycerides-to-HDL
Interval 0.86 to 1.87
|
1.45 ratio of Triglycerides-to-HDL
Interval 0.99 to 2.31
|
SECONDARY outcome
Timeframe: 12 MonthLDL-C
Outcome measures
| Measure |
Sugar-Sweetened Beverages
n=60 Participants
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
n=60 Participants
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=66 Participants
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
LDL-C
|
103 mg/dL
Standard Deviation 31
|
104 mg/dL
Standard Deviation 30
|
109 mg/dL
Standard Deviation 29
|
SECONDARY outcome
Timeframe: 12 MonthhsCRP
Outcome measures
| Measure |
Sugar-Sweetened Beverages
n=60 Participants
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
n=60 Participants
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=66 Participants
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
hsCRP
|
0.86 mg/L
Interval 0.39 to 1.8
|
0.64 mg/L
Interval 0.39 to 1.81
|
0.85 mg/L
Interval 0.39 to 1.76
|
SECONDARY outcome
Timeframe: 12 MonthFibrinogen
Outcome measures
| Measure |
Sugar-Sweetened Beverages
n=60 Participants
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
n=60 Participants
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=66 Participants
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
Fibrinogen
|
244 mg/dL
Standard Deviation 49
|
248 mg/dL
Standard Deviation 62
|
236 mg/dL
Standard Deviation 73
|
SECONDARY outcome
Timeframe: 12 MonthUric Acid
Outcome measures
| Measure |
Sugar-Sweetened Beverages
n=60 Participants
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
n=60 Participants
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=66 Participants
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
Uric Acid
|
5.2 mg/dL
Standard Deviation 1.3
|
5.1 mg/dL
Standard Deviation 1.4
|
5.4 mg/dL
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 12 MonthALT
Outcome measures
| Measure |
Sugar-Sweetened Beverages
n=60 Participants
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
n=60 Participants
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=66 Participants
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
ALT
|
16 U/L
Interval 12.0 to 21.0
|
16 U/L
Interval 13.0 to 23.0
|
17 U/L
Interval 11.0 to 26.0
|
SECONDARY outcome
Timeframe: 12 MonthSystolic Blood Pressure
Outcome measures
| Measure |
Sugar-Sweetened Beverages
n=60 Participants
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
n=60 Participants
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=66 Participants
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
Systolic Blood Pressure
|
109 mmHg
Standard Deviation 10
|
107 mmHg
Standard Deviation 11
|
106 mmHg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 12 MonthDiastolic Blood Pressure
Outcome measures
| Measure |
Sugar-Sweetened Beverages
n=60 Participants
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
n=60 Participants
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=66 Participants
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
Diastolic Blood Pressure
|
68 mmHg
Standard Deviation 9
|
67 mmHg
Standard Deviation 8
|
67 mmHg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 12 MonthPopulation: Data missing for 1 subject in ASB group.
Body Weight
Outcome measures
| Measure |
Sugar-Sweetened Beverages
n=60 Participants
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
n=59 Participants
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=66 Participants
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
Body Weight
|
78.0 kg
Standard Deviation 17.4
|
76.8 kg
Standard Deviation 17.2
|
78.3 kg
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: 12 MonthPopulation: Data missing for 1 subject in USB group.
Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day
Outcome measures
| Measure |
Sugar-Sweetened Beverages
n=60 Participants
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
n=60 Participants
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=65 Participants
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
Diet Quality: Sugar-Sweetened Beverage Consumption
|
2.5 Servings per day
Standard Deviation 1.8
|
0.1 Servings per day
Standard Deviation 0.3
|
0.2 Servings per day
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 12 MonthPopulation: Data missing for 1 subject in SSB group.
We evaluated preference for sweet taste using ten solutions ranging in sucrose concentration (%m/v) from 0% (sample 1) to 18% (sample 10). After tasting each solution, participant reported the sample number corresponding to his or her overall favorite.
Outcome measures
| Measure |
Sugar-Sweetened Beverages
n=59 Participants
Provision of beverages: Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Artificially-sweetened Beverages
n=60 Participants
Provision of beverages: Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Unsweetened Beverages
n=66 Participants
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
Preference for Sweet Taste
|
6 Sample number
Interval 5.0 to 7.0
|
6 Sample number
Interval 4.5 to 7.0
|
5 Sample number
Interval 4.0 to 6.0
|
Adverse Events
Group 1
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=67 participants at risk
Sugar-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Group 2
n=67 participants at risk
Artificially-sweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
Group 3
n=69 participants at risk
Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Body Aches
|
1.5%
1/67 • Number of events 1 • 1 year
|
0.00%
0/67 • 1 year
|
0.00%
0/69 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.5%
1/67 • Number of events 1 • 1 year
|
0.00%
0/67 • 1 year
|
0.00%
0/69 • 1 year
|
|
Nervous system disorders
Headaches and mood swings due to toothache
|
0.00%
0/67 • 1 year
|
1.5%
1/67 • Number of events 1 • 1 year
|
0.00%
0/69 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place