Effects of a high fructose diet on gut health and metabolism
The Effects of a High Fructose Diet on the Gut Microbiome and Metabolic Health: A Controlled Clinical Intervention Study
This study is testing how eating a high fructose diet affects gut health and metabolism in people who may struggle to digest fructose.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06329544 on ClinicalTrials.gov |
What this trial studies
This study investigates how a high fructose diet affects metabolic health by altering the gut microbiome. It involves a controlled cross-over dietary intervention where 30 participants will consume either a fructose or glucose diet for 12 days, separated by a 10-day washout period. The participants will be selected based on their fructose malabsorption status, determined through a hydrogen breath test. The goal is to understand the mechanisms linking dietary fructose to metabolic outcomes, particularly in relation to conditions like Type 2 Diabetes and obesity.
Who should consider this trial
Good fit: Ideal candidates are individuals identified as fructose malabsorbers who do not have major medical illnesses or restrictive dietary habits.
Not a fit: Patients with diagnosed Type 1 or Type 2 diabetes, significant medical illnesses, or those on medications affecting metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that improve metabolic health and reduce the risk of Type 2 Diabetes.
How similar studies have performed: While the impact of fructose on metabolic health is a known concern, this specific approach examining the gut microbiome's role is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be determined to be a fructose malabsorber (screening visit) via hydrogen breath test. Exclusion Criteria: * Use of probiotic/prebiotic/synbiotic supplements * Consumption of \> 1 sugar sweetened beverage per day * Antibiotics within 3 months prior to enrollment or during intervention * Vegetarian, vegan or other restrictive dietary habits * Food allergy * Alcohol consumption in excess of 2 drink per day The following additional factors will be exclusion criteria: * Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder * Physical, mental, or cognitive handicaps that prevent participation * Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles; * Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs; e) restrictive dietary habits; * food allergy; * excess alcohol consumption; * recent use of pro-, pre- or Synbiotics of receipt of antibiotics within 3 months prior to enrollment or during the intervention; * consumption of greater than 1 sugar sweetened beverage per day prior to enrollment
Where this trial is running
New York, New York
- Mount Sinai Morningside — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ryan Walker — Icahn School of Medicine at Mount Sinai
- Study coordinator: Ryan Walker, PhD
- Email: ryan.walker@mssm.edu
- Phone: 212-824-7088
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.