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Starch study seeks to tame blood sugar swings

NCT ID NCT07408479

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether eating more slowly digestible starch and resistant starch can help control blood sugar and improve health in people with insulin resistance. Forty adults will follow a special diet for two months, with regular blood, urine, and stool tests to track changes. The goal is to understand how starch type affects glucose levels, inflammation, and gut bacteria.

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 40 people

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

Started

Nov 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 75 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: • General criteria: * Age between 18 and 75 years (bounds included) * HOMA-IR ≥ 2.5 * Body Mass Index (BMI) between 25 and 40 kg/m² (bounds included) * Stable weight over the past 3 months (+/- 5% of body weight) * Waist circumference \> 80 cm for women, \> 94 cm for men * Sedentary subject or subject practising regular and stable physical activity for the duration of the study (maximum 4 hours per week) * Able to understand the provided information and having signed the informed consent forms * Able to read and write in French * Having a freezer and comfortable with storing stool samples at home * Having undergone a prior medical examination during the screening visit Food-related criteria: * Willing to modify their diet for 2 months * No food intolerances or allergies * Regular consumption of the study products * Fiber intake ≤ 25 g/day * Willing to consume three main meals with no more than one snack per day and to take meals or snacks at least two hours apart Exclusion Criteria: * General criteria: * Adult under legal protection (guardianship or curatorship) * Person with unstable medical or psychological conditions that, according to the investigator, could lead to non-compliance or non-cooperation during the study or compromise safety or participation (as per Articles L.1121-6, L.1121-8, L.1121-9, and L.1122-1-2 of the French Public Health Code) * Presence of a condition identified during clinical examination or medical interview that could interfere with study evaluations, as judged by the investigator * Person deprived of liberty by judicial or administrative decision * Failure to comply with the exclusion period of another study as indicated in the "national volunteer database" * Person exceeding the annual compensation limit for participation in research protocols * Tobacco (or vaping equivalent) consumption \> 5 cigarettes per day and inability to abstain from smoking or vaping from the evening prior to exploration days specified in the protocol * Alcoholism or alcohol abuse (\> 30 g/day). Consuming more than three alcoholic drinks per day is considered abusive. One alcoholic drink corresponds to 30 mL of spirits, 120 mL of wine, or 330 mL of beer or abuse or dependency on another drug * Person not affiliated with a social security system or benefiting from a similar scheme * Absence of valid, approved health certificates in the event of government measures during an exceptional epidemic situation * Biological criteria: * Fasting blood glucose ≥ 7 mmol/L or ≥ 1.26 g/L * Triglycerides \> 4 g/L * LDL-cholesterol \> 1.90 g/L * eGRF (estimated glomerular filtration rate) \< 60 ml/min * Other biological abnormality with significant clinical relevance according to the investigator * Population-related criteria : * Person with a specific dietary regimen (vegetarian, lacto-vegetarian, vegan, high-protein, low-carbohydrates, weight-loss diet, etc.) * Person consuming dietary supplements (prebiotics, probiotics, or minerals such as divalent cations like magnesium and calcium) regularly in the month before the selection visit and during the study * Blood donation within 2 months prior to the selection visit * Claustrophobia preventing indirect calorimetry measurement * Limited venous access making blood sampling and catheter placement difficult * Therapeutic and medical criteria: * Type 1 or Type 2 diabetes * Systolic blood pressure ≥ 140 mmHg * Diastolic blood pressure ≥ 90 mmHg * Hypertension treatment * Known endocrine pathology interfering with carbohydrate metabolism (uncontrolled thyroid dysfunction, acromegaly, hypercortisolism, etc.) * Gastrointestinal diseases with an inflammatory component or associated with malabsorption or considered likely to interfere with the results of the study; * History of bloody diarrhea * Exocrine pancreatic insufficiency * History of bariatric surgery * History of digestive surgery, except appendectomy and simple hernia repair * Severe eating disorders (e.g., anorexia, bulimia, binge-eating disorder, night-eating syndrome) as judged by the investigator; * Hepatocellular insufficiency * Immunosuppressed individuals (e.g., those with AIDS, lymphoma, long-term corticosteroid therapy, chemotherapy, or allogeneic transplant) * Central venous catheter carriers and post-surgical patients * Any other clinically significant unstable or untreated abnormality in the immunological, neoplastic, endocrine, hematological, gastrointestinal, hepatic, neurological, or psychiatric domains, as judged by the investigator * Obesity medication use within the past 3 months or during the study * Antibiotic use in the month prior to explorations (for common beta-lactam antibiotics) or within 3 months before explorations (for other antibiotics), as judged by the investigator * Daily laxative use within the 3 months prior to explorations or other medications significantly interfering with gut microbiota composition; * Use of treatments that could interfere with study measurements, as judged by the study's co-investigating physicians * Pregnant, planning to become pregnant (verified by a blood pregnancy test), or breastfeeding woman * Person with known allergy to adhesive materials

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Conditions

The condition(s) this trial relates to.

Insulin Resistance

As listed by the trial registrant

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

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

  • Centre de Recherche en Nutrition Humaine Rhone-Alpes

    RECRUITING

    Lyon, 69310, France

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Other studies related to the condition(s) this trial covers.