Gut fermentation and metabolism in teens and young adults with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study gives an oral lactulose product to youths aged 15–22 with BMI above the 85th percentile to provoke colonic fermentation and measure metabolic responses. Investigators will track changes in adipose tissue lipolysis, plasma free fatty acids, and entero‑endocrine hormones such as PYY, GLP‑1, and ghrelin under controlled conditions. The protocol focuses on how insulin resistance modifies the adipose tissue and hormonal responses to fermentation. Participants with confounding conditions or on medications that affect insulin resistance are excluded to isolate the fermentation effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 15 to 22 years
* In puberty (girls and boys: Tanner stage III-V);
* BMI \>85th

Exclusion Criteria:

* Pregnancy;
* endocrinopathies (e.g., Cushing syndrome);
* substance abuse;
* medications affecting insulin resistance such as metformin, GLP-1 analogues; -
* high fibers intake (\> 30g/day) as assessed by a 3-day food record.

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: NICOLA SANTORO, MD, PhD — Yale University
• Study coordinator: NICOLA SANTORO, MD, PhD
• Email: nicola.santoro@yale.edu
• Phone: 2037852819

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.