Impact of Meal Timing on Glycemic Profile in Latino Adolescents With Obesity

NCT05391438 | Completed Results

• 1 other identifier: CHLA-22-00119
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

In adolescents, conventional obesity treatment comprehensively addresses nutritional, activity, and behavioral topics. Due to limited resources in historically marginalized communities, implementation of nutrition-based interventions that require easy access to fresh food and ability to change the home environment is difficult, which may exacerbate health disparities. It is critical to find nutrition strategies and recommendations that are impactful, sustainable, and cost effective across all communities. There is growing interest in time-based interventions focusing on "when" food is consumed rather than on prescribed macronutrient composition. Time-restricted eating (TRE) is a type of meal-timing which involves fasting for at least 14-hours per day and eating over a 10-hour eating window initiated in the morning, mid-day, or afternoon. TRE recommendations are simple in merely dictating when eating occurs and thus may represent a more straightforward approach for adolescents than other caloric restriction regimens relying on numeracy (kilocalories and macronutrients) and goal setting. In adults, early-day TRE has been shown to reduce body weight, fasting glucose, and insulin resistance. By contrast, restricting food intake to the evening has produced mostly null results or even worsened post prandial glucose levels and β-cell responsiveness. To date, there has been no trial comparing early vs. late TRE on glycemic profiles in adolescents, and it is unclear how meal-timing impacts glycemic profiles in youth. The optimal timing of food intake for adolescents may be very different than adults due to increasing sex steroids and growth hormone levels overnight which may contribute to increased insulin resistance in the early morning. The proposed proof-of-concept study addresses this question by measuring metabolic response to a test meal consumed in the morning, afternoon, and evening among 30 adolescents with obesity using a within participant design. These findings will provide the needed research base for the refinement of TRE interventions in adolescence.

Conditions

Pediatric Obesity; Meal Timing

Outcome Measures

Primary Outcomes (2)

• Change in Insulinogenic Index From Baseline After Test Meal From Venous Sample

  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.

  Baseline to Day 14

• Change in Incremental Glucose Area Under the Curve From Baseline After Test Meal From Venous Sample

  Glucose incremental area under curve: The positive area under the post-meal glucose curve after subtracting the glucose value at the start.

  Baseline to Day 14

Secondary Outcomes (1)

• Change in Quantifying Glucagon Like Peptide 1 Concentrations From Baseline After Test Meal From Venous Sample

  Baseline to Day 14

Study Arms (1)

Meal-timing

OTHER

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.

Other: Meal-timing

Interventions

Meal-timing OTHER

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.

Meal-timing

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 13-19 years
• Hispanic or Latino defined by the NIH as a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race; (3)Tanner stage III and above
• (4) body mass index \> 95th percentile (5) participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods.

You may not qualify if:

• diagnosis of Prader-Willi Syndrome, brain tumor or hypothalamic obesity
• serious intellectual disability
• parent/guardian-reported physical, mental of other inability to participate in the assessments
• previous bariatric surgery
• current use of an anti-obesity or other diabetes medication (e.g., phentermine, topiramate, orlistat, GLP-1 agonist, naltrexone, buproprion, or insulin)
• current participation in other interventional weight loss studies.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alaina Vidmar
• Organization: Children's Hospital Los Angeles

avidmar@chla.usc.edu

3236614606

Study Officials

• Alaina Vidmar, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Model Details: 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. 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. The primary endpoints will be glucose, insulin, and C-peptide area under the curve, insulinogenic index, and glucose variability as captured by percent time in range on CGM following the test meal.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 26, 2022
• Study Start: September 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)