High Fructose Diet, the Gut Microbiome, and Metabolic Health
Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Mar 18, 2024
Trial Information
Current as of May 30, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating how a high fructose diet affects our gut health and its connection to metabolic conditions like type 2 diabetes and obesity. Researchers want to understand if eating too much fructose, which is commonly found in sugary foods and drinks, can change the bacteria in our gut and increase the risk of developing metabolic health issues. They will do this by having 30 participants follow two different diets for 12 days each—one high in fructose and the other high in glucose, with a break in between. Participants will be monitored for changes in their gut bacteria, metabolism, and other health markers.
To be eligible, participants need to have difficulty absorbing fructose, which will be determined through a simple breath test. They should not be taking certain supplements, consuming more than one sugary drink per day, or have any major health issues like diabetes. Throughout the study, participants can expect to eat a controlled diet and provide stool samples for analysis. The findings from this research could help identify new ways to improve metabolic health, especially for those who consume a lot of fructose, such as children.
Gender
ALL
Eligibility 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
About Icahn School Of Medicine At Mount Sinai
The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Patients applied
Trial Officials
Ryan Walker
Principal Investigator
Icahn School of Medicine at Mount Sinai
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported