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Completed

NCT Number: NCT03454828

Mechanisms of Obesity and Its Metabolic Complications in Youth

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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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

15 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Research Unit

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

obese carbohydrate diet

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

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).

Primary outcomes

  1. Rate of Appearance of Acetate

    Time frame: Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours)

    Starting at 08:00, we began a 10-h, primed, continuous, peripheral venous infusion of 99% sodium [d3]-acetate with a priming dose of 200 μg · kg-1 · min-1 for 4 min and a continuous infusion rate of 59.5 μg · kg-1 · min-1 for 10 h. After 180 min from the start of the infusion, subjects received 20 g of lactulose per os, dissolved in 30 mL of water.

  2. Percent of Hepatic de Novo Lipogenesis.

    Time frame: Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours)

    The percent of hepatic de novo lipogenesis (DNL) refers to the proportion of fatty acids in the liver that are derived from a de novo synthesis pathway, rather than from dietary sources.

  3. Change in the Rate of Appearance of Acetate

    Time frame: Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours)

    The changes in rate of appearance of acetate (RaAcetate) are measured averaging the basal RaAcetate 9 timepoints (2 and 3 hours) and the post-lactulose RaAcetate (timepoints 7, 8, 9 and 10 hours).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2018
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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