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Sugar shock: could fructose be wrecking your gut and raising diabetes risk?

NCT ID NCT06329544

Knowledge-focused Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how eating a lot of fructose (a type of sugar) changes the bacteria in your gut and affects your risk for type 2 diabetes and fatty liver. Thirty adults with obesity, diabetes, or fatty liver will eat a high-fructose or high-glucose diet for 12 days, then switch after a break. Researchers will measure changes in gut bacteria, blood markers, and liver fat to understand the link between sugar, the microbiome, and metabolic disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fructose (dietary supplement)
What this could lead to
If successful, this study could reveal how excess fructose harms metabolic health through gut microbiome changes, pointing to new dietary or microbiome-based strategies to reduce diabetes risk.
What could go wrong
This is a small, early-stage study with only 30 participants, so results may not apply to everyone. It is designed to understand mechanisms, not to test a treatment, so no direct health benefit is expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

fatty liver disease metabolic dysfunction-associated steatotic liver disease Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MASLD Obesity Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mount Sinai Morningside

    RECRUITING

    New York, New York, 10025, United States

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