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Can cutting carbs reshape the Body's sugar response?

NCT ID NCT07802275

Knowledge-focused Sponsor: Azienda Ospedaliero, Universitaria Pisana Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study compares two diets in people with overweight and early signs of blood sugar problems: a low-carbohydrate diet and a Mediterranean diet, both designed to produce similar weight loss. Each participant follows both diets for four weeks, in random order, with a break in between. After each diet, researchers use a special sugar drink test to measure how quickly sugar enters the blood, how much the liver releases, and how fast the body clears sugar. The goal is to see whether carbohydrate restriction changes these processes independently of weight loss.

What this could mean

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

Active substance
A 4-week low-carbohydrate diet (20% carbs) compared with a 4-week Mediterranean diet (50% carbs), both with mild calorie restriction
What this could lead to
If it works, this could clarify whether cutting carbohydrates changes how the body handles sugar after meals, which might inform dietary advice for people with prediabetes.
What could go wrong
The trial is small and short, and results may not apply to everyone. Differences in glucose handling could be modest or hard to detect.

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

29 people

The number who actually took part.

Started

Nov 2019

Finished

Aug 2026

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * both females and males * age 18-65 years * BMI 25-40 kg/m2 * impaired glucose regulation (defined as fasting plasma glucose 5.6-6.9 mmol/L, 1-h plasma glucose ≥8.6 mmol/L, 2-h plasma glucose 7.8-11.0 mmol/L, or HbA1c 39-47 mmol/mol) Exclusion Criteria: * Diabetes mellitus * Chronic kidney disease * Heart failure * Severe liver disease * Medications known to interfere with carbohydrate metabolism or intestinal nutrient absorption * Metabolic surgery

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Conditions

The condition(s) this trial relates to.

carbohydrate metabolism disease glucose intolerance Insulin Resistance Obesity obesity disorder Overweight prediabetes syndrome type 2 diabetes mellitus

As listed by the trial registrant

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

Carbohydrate metabolism Diet interventions Obesity & overweight Prediabetes

Contacts and locations

Locations

  • Laboratory of Metabolism, Nutrition and Atherosclerosis, University of Pisa

    Pisa, PI, 56126, Italy

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