Mechanisms of Obesity and Its Metabolic Complications in Youth

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-18

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity, Childhood

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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obese carbohydrate diet

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

Group Type EXPERIMENTAL

obese carbohydrate diet

Intervention Type DIETARY_SUPPLEMENT

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 diet

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

Group Type ACTIVE_COMPARATOR

lean carbohydrate diet

Intervention Type DIETARY_SUPPLEMENT

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).

Interventions

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obese carbohydrate diet

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).

Intervention Type DIETARY_SUPPLEMENT

lean carbohydrate diet

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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.