Mechanisms of Obesity and Its Metabolic Complications in Youth

Yale University

Status: Completed

Conditions: Obesity, Childhood

Treatments: Dietary Supplement: lean carbohydrate diet; Dietary Supplement: obese carbohydrate diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03454828

1R01DK114504-01A1 (U.S. NIH Grant/Contract)

2000022239

Details and patient eligibility

About

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.

Full description

This would be the first study determining the effect of SCFA synthesis on hepatic de novo lipogenesis and to assess whether and how isocaloric dietary changes (namely low carbohydrates) might modify the composition of the gut microbiota and reduce the synthesis of SCFA during adolescence, a sensitive period for the development of obesity.

Enrollment: 38 patients

Sex: All

Ages: 15 to 21 years old

Volunteers: Accepts Healthy Volunteers

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 <85th for lean cohort; BMI >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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

obese carbohydrate diet

Experimental group

Description:

Obese adolescents with a body mass index (BMI) \>95th percentile.

Treatment:

Dietary Supplement: obese carbohydrate diet

lean carbohydrate diet

Active Comparator group

Description:

Lean adolescents with a body mass index (BMI) \<85th percentile.

Treatment:

Dietary Supplement: lean carbohydrate diet