Trial Outcomes & Findings for Impact of Meal Timing on Glycemic Profile in Latino Adolescents With Obesity (NCT NCT05391438)
NCT ID: NCT05391438
Last Updated: 2024-10-23
Results Overview
Baseline and post-meal samples will be assayed for glucose, insulin, and c-peptide at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after the meal is consumed. The Insulinogenic index (change in insulin/change in glucose over the first 30 min after the load) will be calculated. IGI has been widely used as an index of early phase insulin secretion in clinical studies. It is highly correlated with the acute insulin response on intravenous glucose tolerance test and is considered a reasonable surrogate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Baseline to Day 14
Results posted on
2024-10-23
Participant Flow
Participant milestones
| Measure |
Meal-timing
All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period.
Meal-timing: We propose a cross-over, proof-of-concept study to measure glycemic and metabolic responses to a test meal (controlled for macronutrient profile and caloric amount) administered at various times of the day (early vs. afternoon vs. late) in thirty Latino adolescents (ages 13-19 years), with obesity, without diabetes, to determine how timing of eating impacts glycemic response to the test meal after a 16-h fasting period. All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. Baseline and post-meal samples will be assayed for glucose, insulin, c-peptide, GLP-1, GIP, PP at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after glucose.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
7 subjects withdrew
Baseline characteristics by cohort
| Measure |
Meal-timing
n=22 Participants
All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period.
Meal-timing: We propose a cross-over, proof-of-concept study to measure glycemic and metabolic responses to a test meal (controlled for macronutrient profile and caloric amount) administered at various times of the day (early vs. afternoon vs. late) in thirty Latino adolescents (ages 13-19 years), with obesity, without diabetes, to determine how timing of eating impacts glycemic response to the test meal after a 16-h fasting period. All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. Baseline and post-meal samples will be assayed for glucose, insulin, c-peptide, GLP-1, GIP, PP at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after glucose.
|
|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
|
Age, Continuous
|
16.5 Years
STANDARD_DEVIATION 1.0 • n=22 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=15 Participants • 7 subjects withdrew
|
|
Sex: Female, Male
Male
|
12 Participants
n=15 Participants • 7 subjects withdrew
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 14Baseline and post-meal samples will be assayed for glucose, insulin, and c-peptide at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after the meal is consumed. The Insulinogenic index (change in insulin/change in glucose over the first 30 min after the load) will be calculated. IGI has been widely used as an index of early phase insulin secretion in clinical studies. It is highly correlated with the acute insulin response on intravenous glucose tolerance test and is considered a reasonable surrogate.
Outcome measures
| Measure |
Meal-timing
n=15 Participants
All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period.
Meal-timing: We propose a cross-over, proof-of-concept study to measure glycemic and metabolic responses to a test meal (controlled for macronutrient profile and caloric amount) administered at various times of the day (early vs. afternoon vs. late) in thirty Latino adolescents (ages 13-19 years), with obesity, without diabetes, to determine how timing of eating impacts glycemic response to the test meal after a 16-h fasting period. All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. Baseline and post-meal samples will be assayed for glucose, insulin, c-peptide, GLP-1, GIP, PP at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after glucose.
|
|---|---|
|
Change in Insulinogenic Index From Baseline After Test Meal From Venous Sample
4 PM
|
153 Microunits per milliliter
Interval 84.0 to 266.0
|
|
Change in Insulinogenic Index From Baseline After Test Meal From Venous Sample
8 AM
|
268 Microunits per milliliter
Interval 83.0 to 515.0
|
|
Change in Insulinogenic Index From Baseline After Test Meal From Venous Sample
12 PM
|
215 Microunits per milliliter
Interval 111.0 to 286.0
|
PRIMARY outcome
Timeframe: Baseline to Day 14Glucose incremental area under curve: The positive area under the post-meal glucose curve after subtracting the glucose value at the start.
Outcome measures
| Measure |
Meal-timing
n=15 Participants
All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period.
Meal-timing: We propose a cross-over, proof-of-concept study to measure glycemic and metabolic responses to a test meal (controlled for macronutrient profile and caloric amount) administered at various times of the day (early vs. afternoon vs. late) in thirty Latino adolescents (ages 13-19 years), with obesity, without diabetes, to determine how timing of eating impacts glycemic response to the test meal after a 16-h fasting period. All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. Baseline and post-meal samples will be assayed for glucose, insulin, c-peptide, GLP-1, GIP, PP at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after glucose.
|
|---|---|
|
Change in Incremental Glucose Area Under the Curve From Baseline After Test Meal From Venous Sample
8 AM
|
17705 mg/dL·min
Interval 15154.0 to 20152.0
|
|
Change in Incremental Glucose Area Under the Curve From Baseline After Test Meal From Venous Sample
12 PM
|
18279 mg/dL·min
Interval 17614.0 to 18860.0
|
|
Change in Incremental Glucose Area Under the Curve From Baseline After Test Meal From Venous Sample
4 PM
|
19122 mg/dL·min
Interval 18427.0 to 20493.0
|
SECONDARY outcome
Timeframe: Baseline to Day 14Glucagon like peptide 1 concentrations will be measured in duplicate from plasma samples using Millipore Enzyme-linked Immunosorbent Assays (ELISA) or multiplex assays according to the recommendations of the manufacturer (Birmington, MA).
Outcome measures
| Measure |
Meal-timing
n=15 Participants
All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period.
Meal-timing: We propose a cross-over, proof-of-concept study to measure glycemic and metabolic responses to a test meal (controlled for macronutrient profile and caloric amount) administered at various times of the day (early vs. afternoon vs. late) in thirty Latino adolescents (ages 13-19 years), with obesity, without diabetes, to determine how timing of eating impacts glycemic response to the test meal after a 16-h fasting period. All participants will consume three standard test meals administered in random order at different times of day over two-weeks: (1) Early: test meal consumed at 8 AM; (2) Afternoon: test meal consumed at 12 PM; (3) Late: test meal consumed at 4 PM. A continuous glucose monitor (CGM) will be placed on the participant for the duration of the 2-week period. Baseline and post-meal samples will be assayed for glucose, insulin, c-peptide, GLP-1, GIP, PP at times -10, -5, 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes after glucose.
|
|---|---|
|
Change in Quantifying Glucagon Like Peptide 1 Concentrations From Baseline After Test Meal From Venous Sample
8 AM
|
6 pg/mL
Interval 1.0 to 7.0
|
|
Change in Quantifying Glucagon Like Peptide 1 Concentrations From Baseline After Test Meal From Venous Sample
12 PM
|
2 pg/mL
Interval 2.0 to 10.0
|
|
Change in Quantifying Glucagon Like Peptide 1 Concentrations From Baseline After Test Meal From Venous Sample
4 PM
|
8 pg/mL
Interval 1.0 to 14.0
|
Adverse Events
Early
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Afternoon
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Late
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place