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RecruitingNCT07408479GLYMICAREUpdated Feb 13, 2026

Impact of Starch Digestibility on Glycemic Variability and Control, Cardiometabolic and Inflammatory Profiles, Microbiota and Intestinal Health in Subjects With Insulin Resistance

An interventional study of Balanced diet high in Slowly Digestible Starch and Resistant Starch and Balanced diet low in Slowly Digestible Starch and Resistant Starch in Insulin Resistance, sponsored by Mondelēz International, Inc.. Recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Mondelēz International, Inc. · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 66 studies in Insulin Resistance with a site in France — 10 open to participants now, 11 under way, none of them phase 3. Insulin Resistance · France.

Planned enrollment
26th of 52
40 · median 40
Started
2025
with 2 others
No phase
34 of 66
5 open now
Primary completion
2027-12
later than 9 of 10 live
Registered
65th of 66
by date

Among the 66 studies in Insulin Resistance with a site in France, this one is the 26th largest by planned enrollment of the 52 interventional ones, is one of 3 that started in 2025, is one of 34 with no phase, reaches primary completion later than 9 of the 10 other live ones, and was the 65th registered.

By phase

66 studies; the count open now beside each. This study's row is marked.

No phasethis study34 · 5 open
Observational14 · 5 open
Phase 35 · 0 open
Phase 45 · 0 open
Phase 24 · 0 open
Phase 2/32 · 0 open
Phase 11 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2002; this study’s year is marked. 3 started in 2025.

Size and results

Median enrollment 40 across the 52 interventional studies, 114 across the 14 observational. Of the 51 that completed or were terminated, 5 (10%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 66 studies in Insulin Resistance with a site in France, or all of them as a file.
02

Study summary

To study the potential impact of a diet rich in both Slowly Digestible Starch (SDS) and Resistant Starch (RS), we propose a 2-month nutritional intervention study in which we will study the evolution of carbohydrate variability and metabolism and health-related parameters in 40 volunteers with insulin resistance. Regular sampling of blood, urine and faeces as well as continuous measurement of blood glucose levels will be performed to assess changes in blood glucose levels, insulin resistance, lipid metabolism, inflammation and the composition of the microbiota following the introduction of starch products rich in SDS and RS into the diet.

03

Conditions studied

  • Insulin Resistance

Browse trials for

Keywords

  • Slowly Digestible Starch
  • SDS
  • Resistant Starch
  • Insulin resistant subjets
  • Glycemic control
  • Continuous Glucose Monitoring System
  • CGMS
  • Diet
  • Mean Amplitude of Glucose Excursion
  • microbiota
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • General criteria:
  • Age between 18 and 75 years (bounds included)
  • HOMA-IR ≥ 2.5
  • (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 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

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 ) \< 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
    • individuals (e.g., those with AIDS, lymphoma, long-term therapy, chemotherapy, or transplant)
    • Central venous catheter carriers and post-surgical patients
    • Any other 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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    High SDS-RS diet

    Balanced diet containing high levels of Slowly digestible Starch (SDS) and Resistant Starch (RS)

    Other: Balanced diet high in Slowly Digestible Starch and Resistant Starch

  • Placebo comparator
    Low SDS-RS diet

    Balanced diet containing low levels of Slowly digestible Starch (SDS) and Resistant Starch (RS)

    Other: Balanced diet low in Slowly Digestible Starch and Resistant Starch

Interventions

  • OtherBalanced diet high in Slowly Digestible Starch and Resistant Starch

    Diet where all the starchy foods were selected based on their SDS and RS content. This diet needs to be easy to apply by subjects. It will be consumed during 2 months

    Also known as: Diet A, H-SDS-RS

  • OtherBalanced diet low in Slowly Digestible Starch and Resistant Starch

    Diet where all the starchy foods were selected based on their SDS and RS content. This diet needs to be easy to apply by subjects. It will be consumed during 2 months

    Also known as: Diet B, L-SDS-RS

06

What researchers measure

Primary outcomes

  1. Change in MAGE measured on 3 occasions between diets High or Low in SDS and RS

    Mean Amplitude of Glucose Excursions (MAGE) from CGMS record

    Time frame: Evaluations done before, after 1 week and after 2 months on a diet

Secondary outcomes

  1. Glycemia iAUC after a standard challenge test (FlexMeal) during the first metabolic day

    iAUC of postprandial glycemia

    Time frame: 5 hours post standard challenge test during visit 2 (before starting nutritional intervention)

  2. Insulin iAUC after a standard challenge test (FlexMeal) during the first metabolic day

    iAUC of postprandial insulinemia

    Time frame: 5 hours post standard challenge test during visit 2 (before starting nutritional intervention)

  3. GLP-1 iAUC after a standard challenge test (FlexMeal) during the first metabolic day

    GLP-1 iAUC

    Time frame: 5 hours post standard challenge test during visit 2 (before starting nutritional intervention)

  4. Inflammatory status comparison during the first metabolic day : CRP concentration

    C-Reactive Protein (CRP)

    Time frame: At baseline during V2 (before starting nutritional intervention)

  5. Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : TNFa iAUC

    iAUC of TNFa

    Time frame: 5 hours post challenge test during visit 2 (before starting nutritional intervention)

  6. Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : IL6 iAUC

    iAUC of Interleukin 6 (IL-6)

    Time frame: 5 hours post challenge test during visit 2(before starting nutritional intervention)

  7. Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : IL1Ra iAUC

    iAUC of Interleukin-1 Receptor a (IL1Ra)

    Time frame: 5 hours post challenge test during visit 2 (before starting nutritional intervention)

  8. Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day : IL18 iAUC

    iAUC of Interleukin-18 (IL-18)

    Time frame: 5 hours post challenge test during visit 2 (before starting nutritional intervention)

  9. Glycemic impacts comparison following the intake of a diet either high or low in SDS and RS

    Glycemia concentration

    Time frame: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  10. Insulinemic impacts comparison following the intake of a diet either high or low in SDS during the time course of the study

    Insulin concentration

    Time frame: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  11. Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : CRPus concentration

    CRPus

    Time frame: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  12. Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : TNFa concentration

    TNFa concentration

    Time frame: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  13. Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL6 concentration

    IL6 concentration

    Time frame: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  14. Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL1Ra concentration

    IL1Ra concentration

    Time frame: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  15. Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL18 concentration

    IL18 concentration

    Time frame: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  16. Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : MDA concentration

    Malondialdehyde (MDA) concentration

    Time frame: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  17. Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : Urinary isoprostanes concentration

    Urinary isoprostanes

    Time frame: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  18. Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sICAM concentration

    sICAM concentration

    Time frame: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  19. Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sVCAM concentration

    sVCAM concentration

    Time frame: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  20. Glycemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day

    Glycamia iAUC

    Time frame: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  21. Insulinemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day

    Insulin iAUC

    Time frame: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  22. GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the second metabolic day

    GLP1 iAUC

    Time frame: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  23. Inflammatory impacts comparison following 2 months of intake of a diet either high or low in SDS : CRPus concentration

    CRPus concentration

    Time frame: In fasting state during visit 6 (after 8 weeks of nutritional intervention)

  24. Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : TNFa iAUC

    TNFa iAUC

    Time frame: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  25. Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL6 iAUC

    IL6 iAUC

    Time frame: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  26. Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL1Ra iAUC

    IL1Ra iAUC

    Time frame: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  27. Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL18 iAUC

    IL18 iAUC

    Time frame: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  28. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MAGE

    Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia

    Time frame: minimum 3 days to a maximum of 6 days of CGMS record starting at Visit 1, Visit 3 and Visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  29. Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : TIR

    Time In Range (TIR) from CGMS glycaemia

    Time frame: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, Visit 3 or visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  30. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CV

    Coefficient of Variation (CV) from CGMS glycaemia

    Time frame: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  31. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : SD

    Standard Deviation (SD) from CGMS glycaemia

    Time frame: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  32. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MIME

    Mean Indices of Meal Excursions (MIME) from CGMS glycaemia

    Time frame: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  33. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MODD

    Mean Of Daily Differences (MODD) from CGMS glycaemia

    Time frame: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  34. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CONGA

    Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia

    Time frame: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  35. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : ADRR

    Average Daily Risk Range (ADRR) from CGMS glycaemia

    Time frame: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  36. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : LGBI

    Low Blood Glucose Index (LGBI) from CGMS glycaemia

    Time frame: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  37. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : HGBI

    High Blood Glucose Index (HGBI) from CGMS glycaemia

    Time frame: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  38. Mean daylong incremental Area Under the Curve (iAUC) of glycemia, measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study

    The iAUC of glycemia will be calculated using the trapezoid rule. The iAUC includes all area below the curve and above the fasting concentration, with any area beneath fasting being ignored.

    Time frame: from 0 minutes to 360 minutes postprandial during the CGMS record periods starting on visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  39. Mean daylong total Area Under the Curve (tAUC) of glycemia, measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study

    The tAUC will be calculated using the trapezoid rule

    Time frame: from 0 minutes to 360 minutes postprandial during the CGMS record periods starting on visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  40. Diabetes follow-up markers : HbA1c

    HbA1c concentration

    Time frame: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  41. Diabetes follow-up markers : Fructosamine concentration

    Fructosamine concentration

    Time frame: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  42. Diabetes follow-up markers : Glycated Albumin concentration

    Glycated albumin concentration

    Time frame: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  43. Anthropometry parameters

    Height

    Time frame: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  44. Antropometry parameters : body weight

    body weight

    Time frame: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  45. Anthropometric parameters : waist circumference

    waist circumference

    Time frame: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  46. Athropometric parameters : hip circumference

    hip circumference

    Time frame: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  47. Body composition parameters characterisation : total body water

    Total body water measured by bioimpedancemetry

    Time frame: In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)

  48. Body composition parameters characterisation : body fat

    Body fat measured by bioimpedancemetry

    Time frame: In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)

  49. Body composition parameters characterisation : lean mass

    Lean mass measured by bioimpedancemetry

    Time frame: In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)

  50. Resting energy metabolism profile : Resting Metabolism Rate

    Resting Metabolism Rate (RMR) measured by indirect calorimetry

    Time frame: In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)

  51. Exhaled gases - Dihydrogen

    Dihydrogen measured during breath test

    Time frame: Measured at time 0, 60, 120, 180, 240 minutes of breath test during visit 1 and visit 5 ((before and after 7 weeks of nutritional intervention)

  52. Exhaled gases - Methane

    Methane measured during breath test

    Time frame: Measured at time 0, 60, 120, 180, 240 minutes of breath test during visit 1 and visit 5 (before and after 7 weeks of nutritional intervention)

  53. Exhaled gases : Volatile Organic Compounds

    Volatile Organic Compounds

    Time frame: Measured at time T-30 minutes of breath test during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)

  54. Gut microbiota composition

    Whole genome shotgun sequencing

    Time frame: Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  55. Microbiota activity : short chain fatty acids

    Short chain fatty acids measured in fecal samples

    Time frame: Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  56. Microbiota functionlity

    Bacterial enzymes measured in feces

    Time frame: Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  57. Level of physical activity characterisation following the intake of a diet either high or low in SDS during the time course of the study : IPAQ

    International Physical Activity Questionnaire (IPAQ)

    Time frame: Evaluated at the arrival in the laboratory during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Dec 2027, 25 months after the start.

Of 40 industry-sponsored interventional studies with no phase under Insulin Resistance, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 22. This study's planned 25 months is above that.

Counting every sponsor, half of 754 studies reached it within 21 months; a quarter within 9 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2026
First posted
Feb 13, 2026
StartActual
Nov 15, 2025
Primary completionEst.
Dec 2027
CompletionEst.
Jul 2028
Last update
Feb 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07408479
Lead sponsor
Mondelēz International, Inc.
Collaborators
Centre de Recherche en Nutrition Humaine Rhone-Alpe, Unite MetaGenoPolis INRAE
Responsible party
Sponsor
First posted
Feb 13, 2026
Start date
Nov 15, 2025
Primary completion
Dec 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Feb 13, 2026

Study contacts

Julie-Anne Nazare, PhD
Contact
julie-anne.nazare@univ-lyon1.fr
+33 4 78 86 29 81
Alexandra Meynier, PhD
Contact
alexandra.meynier@mdlz.com
+33 1 83 11 45 68
Anne-Laure Castell, MD
principal investigator · Centre de Recherche en Nutrition Humaine Rhone-Alpe

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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