N/A
N=22
Impact of Meal Timing on Glycemic Profile in Latino Adolescents With Obesity
Pediatric Obesity · Meal Timing
Bottom Line
View on ClinicalTrials.gov: NCT05391438 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change in Insulinogenic Index From Baseline After Test Meal From Venous Sample — 268; 215; 153 Microunits per milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Meal-timing (Other)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Los Angeles
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insulinogenic Index From Baseline After Test Meal From Venous Sample |
268; 215; 153 | — |
| PRIMARY Change in Incremental Glucose Area Under the Curve From Baseline After Test Meal From Venous Sample |
17705; 18279; 19122 | — |
| SECONDARY Change in Quantifying Glucagon Like Peptide 1 Concentrations From Baseline After Test Meal From Venous Sample |
6; 2; 8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05391438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.