NCT03454828

Mechanisms of Obesity and Its Metabolic Complications in Youth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 15 Years – 21 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Obesity, Childhood

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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).
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).

Timeline

• Start date: 2018-08-18
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2018-03-06
• Last updated: 2025-10-09
• Results posted: 2025-10-09

Locations

1 site across 1 country: United States