Recruiting at 1 site No phase MASLD

MASLD study: Fructose

Official title High Fructose Diet, the Gut Microbiome, and Metabolic Health

ClinicalTrials.gov ID: NCT06329544

What this study is testing

What it's testing
The study aims to see if eating fructose changes the gut microbiome and whether those changes raise metabolic risk, including insulin resistance and liver fat.
Who it's for
Adults who have fatty liver disease, type 2 diabetes, or obesity.
What's involved
Participants will eat a 12‑day diet where 25% of calories come from added fructose or from glucose, then a 10‑day washout period. They will give stool samples, have blood drawn, and get an MRI of the liver. The research team will analyze the bacteria, their metabolites, and markers of inflammation.
Time commitment
The study lasts about 30 days, with two 12‑day diet periods and a 10‑day washout, plus a few clinic visits for tests.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 25 to 45. Healthy volunteers may be eligible.

You may be able to join if

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

You likely can't join if

  • 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
  • Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder
See the full eligibility criteria
Who can join
  • Participants must be determined to be a fructose malabsorber (screening visit) via hydrogen breath test.
What rules you out
  • 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
  • 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

The study team makes the final eligibility decision.

Where it is enrolling

  • New York, New York, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 25 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.