Clinical trial Recruiting at 1 site Interventional Ages 25 to 45

Effects of a high fructose diet on gut health and metabolism

Official title: The Effects of a High Fructose Diet on the Gut Microbiome and Metabolic Health: A Controlled Clinical Intervention Study

Run by Icahn School of Medicine at Mount Sinai · NCT06329544 · Data updated 2026-11-12

This study is testing how eating a high fructose diet affects gut health and metabolism in people who may struggle to digest fructose.

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Quick facts

Study typeInterventional
Ages25 Years to 45 Years
SexAll
Enrollment30 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedOctober 8, 2024
Main results expectedAugust 31, 2028
Study endsAugust 31, 2028
Registry record updatedDecember 17, 2025
Trial IDNCT06329544 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals identified as fructose malabsorbers who do not have major medical illnesses or restrictive dietary habits.

Probably 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.

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

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.