N/A
N=38
Mechanisms of Obesity and Its Metabolic Complications in Youth
Obesity, Childhood
Bottom Line
View on ClinicalTrials.gov: NCT03454828 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Rate of Appearance of Acetate — 7.40; 7.69; 9.29; 14.7 umol/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- obese carbohydrate diet (Dietary_supplement); lean carbohydrate diet (Dietary_supplement)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Appearance of Acetate |
7.40; 7.69; 9.29; 14.7 | — |
| PRIMARY Percent of Hepatic de Novo Lipogenesis. |
1.96; 2.53; 1.97; 3.38 | — |
| PRIMARY Change in the Rate of Appearance of Acetate |
-2.34; 1.63; -1.59; -0.96 | 0.399 |
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.
Eligibility Criteria
Inclusion Criteria
- Good general health,
- Taking no medication on a chronic basis
- Age 15 to 21 years,
- In puberty (girls and boys: Tanner stage III - V)
- BMI >25th and 95th for obese cohort
- Girls who begin menstruating must have a negative pregnancy test during the study.
Exclusion criteria
- Baseline creatinine >1.0 mg
- Food allergies
- Pregnancy
- Presence of endocrinopathies (e.g. Cushing syndrome)
- Significant chronic illness.
Data sourced from ClinicalTrials.gov (NCT03454828). 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.