Gut fermentation and metabolism in teens and young adults with obesity
Pathogenic Mechanisms of Obesity and Its Cardiometabolic Complications
This will test whether giving lactulose to teens and young adults with obesity and insulin resistance changes gut fermentation in ways that lower fat release from fat tissue and reduce appetite.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 15 Years to 22 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06768827 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are 15–22 years old, in puberty (Tanner III–V), with BMI above the 85th percentile, not pregnant, not taking insulin‑resistance affecting medications, and consuming less than 30 g/day of fiber.
Not a fit: Patients currently using metformin or GLP‑1 analogues, with endocrinopathies, pregnancy, substance abuse, or very high habitual fiber intake are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could point to dietary or fermentable‑substrate strategies to reduce insulin resistance and appetite in youth with obesity.
How similar studies have performed: Prior mechanistic studies by the investigators and others have shown that intestinal fermentation alters FFA and gut hormones and that some responses are blunted in obese, insulin‑resistant youths, but clinical translation is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Haven, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.