CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
obese carbohydrate diet +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03454828
NCT03454828N/ACompleted
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Mechanisms of Obesity and Its Metabolic Complications in Youth

Yale University·interventional·Posted Mar 6, 2018·Updated Oct 9, 2025

In Brief

A clinical study evaluating obese carbohydrate diet and lean carbohydrate diet for Obesity, Childhood. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The overarching goal of this project is to determine whether the effect of gut microbiota on human metabolism might be mediated by short chain fatty acids (SCFA) and whether the SCFA might modulate lipid metabolism.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Childhood
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 6, 2018
Enrollment StartAug 18, 2018
Primary CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 8.3 years ago

Interventions

obese carbohydrate dietdietary

The experimental diet will consist of 30% carbohydrates (CHO), 35% protein, and 35% fat. Since the experimental diet is lower in CHO, the fiber and sugar content will be calculated based on total CHO in the same percentage as the control (0.25 g fiber per each kcal of CHO and 18.2% sugar for total CHO).

lean carbohydrate dietdietary

The control diet composition will follow the American Dietary Guidelines of 55% carbohydrates (CHO), 15% protein, and 30% fat. CHO content will be primarily complex CHO of high quality (14 g fiber/1,000 kcals and \<10% of total kcals in the form of sugar).