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High Fructose Diet, Gut Microbiome, and Metabolic Health Study

This study is looking at how a high fructose diet affects your gut microbiome (the bacteria in your intestines) and overall metabolic health, especially in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Type 2 Diabetes, or Obesity. You would follow either a high fructose diet or a high glucose diet for 12 days. Researchers want to understand how fructose impacts your body and potentially contributes to conditions like Type 2 Diabetes. To join, you must be a fructose malabsorber, meaning your body doesn't fully absorb fructose. The study aims to measure changes in liver fat (Liver proton density fat fraction) and liver scarring (Degree of fibrosis) after three years. The current recruitment status is unclear.

Study design
This is an interventional study with 30 planned participants. It compares a high fructose diet to a high glucose diet.
What's involved
You would follow a specific diet (either high fructose or high glucose) for 12 days. Your liver fat and scarring would be measured at year 3.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three years to measure liver fat and fibrosis.

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NCT06329544

High Fructose Diet, the Gut Microbiome, and Metabolic Health

Recruiting
NAAges 25–45InterventionalPrevention
Icahn School of Medicine at Mount Sinai
~30 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Fructoseglucose

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Liver proton density fat fraction (PDFF)
Measured over year 3
+1 more outcome measured

Conditions

MASLD
Type 2 Diabetes
Obesity

Explore related trials

Hereditary Fructose Intolerance

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Ryan Walker · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Ryan Walker, PhD
[email protected]
212-824-7088
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must be determined to be a fructose malabsorber (screening visit) via hydrogen breath test.

Exclusion

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
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

What this trial measures

  • Liver proton density fat fraction (PDFF)year 3

    Liver proton density fat fraction (PDFF) in %

  • Degree of fibrosisyear 3

    Tissue shear stiffness will be measured in the right hepatic lobe \[in kilopascals (kPa)\] to assess the degree of fibrosis.