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

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.

Study Overview

• Status: Recruiting
• Conditions: Insulin Resistance
• Intervention / Treatment: Other: Balanced diet high in Slowly Digestible Starch and Resistant Starch; Other: Balanced diet low in Slowly Digestible Starch and Resistant Starch

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie-Anne Nazare, PhD; Phone Number: +33 4 78 86 29 81; Email: julie-anne.nazare@univ-lyon1.fr
• Study Contact Backup: Name: Alexandra Meynier, PhD; Phone Number: +33 1 83 11 45 68; Email: alexandra.meynier@mdlz.com

Study Locations

• France
  • Lyon, France, 69310
    • Recruiting
    • Centre de recherche en nutrition humaine Rhone-Alpes
    • Contact: Anne-Laure Castell, MD; Phone Number: +33 4 78 86 19 72; Email: anne-laure.castell@chu-lyon.fr
    • Contact: Maeliss Chisbert, MSc; Email: ext-maeliss.chisbert@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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; Other Names: Diet A; H-SDS-RS
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; 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; Other Names: Diet B; L-SDS-RS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Evaluations done before, after 1 week and after 2 months on a diet

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemia iAUC after a standard challenge test (FlexMeal) during the first metabolic day	iAUC of postprandial glycemia	5 hours post standard challenge test during visit 2 (before starting nutritional intervention)
Insulin iAUC after a standard challenge test (FlexMeal) during the first metabolic day	iAUC of postprandial insulinemia	5 hours post standard challenge test during visit 2 (before starting nutritional intervention)
GLP-1 iAUC after a standard challenge test (FlexMeal) during the first metabolic day	GLP-1 iAUC	5 hours post standard challenge test during visit 2 (before starting nutritional intervention)
Inflammatory status comparison during the first metabolic day : CRP concentration	C-Reactive Protein (CRP)	At baseline during V2 (before starting nutritional intervention)
Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : TNFa iAUC	iAUC of TNFa	5 hours post challenge test during visit 2 (before starting nutritional intervention)
Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : IL6 iAUC	iAUC of Interleukin 6 (IL-6)	5 hours post challenge test during visit 2(before starting nutritional intervention)
Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : IL1Ra iAUC	iAUC of Interleukin-1 Receptor a (IL1Ra)	5 hours post challenge test during visit 2 (before starting nutritional intervention)
Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day : IL18 iAUC	iAUC of Interleukin-18 (IL-18)	5 hours post challenge test during visit 2 (before starting nutritional intervention)
Glycemic impacts comparison following the intake of a diet either high or low in SDS and RS	Glycemia concentration	In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)
Insulinemic impacts comparison following the intake of a diet either high or low in SDS during the time course of the study	Insulin concentration	In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)
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	In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)
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	In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)
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	In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)
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	In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)
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	In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)
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	In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)
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	In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)
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	In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)
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	In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)
Glycemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day	Glycamia iAUC	5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)
Insulinemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day	Insulin iAUC	5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)
GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the second metabolic day	GLP1 iAUC	5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)
Inflammatory impacts comparison following 2 months of intake of a diet either high or low in SDS : CRPus concentration	CRPus concentration	In fasting state during visit 6 (after 8 weeks of nutritional intervention)
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : TNFa iAUC	TNFa iAUC	5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL6 iAUC	IL6 iAUC	5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL1Ra iAUC	IL1Ra iAUC	5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL18 iAUC	IL18 iAUC	5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)
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	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)
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	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)
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	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)
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	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)
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	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)
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	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)
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	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)
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	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)
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	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)
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	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)
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.	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)
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	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)
Diabetes follow-up markers : HbA1c	HbA1c concentration	In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)
Diabetes follow-up markers : Fructosamine concentration	Fructosamine concentration	In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)
Diabetes follow-up markers : Glycated Albumin concentration	Glycated albumin concentration	In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)
Anthropometry parameters	Height	In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)
Antropometry parameters : body weight	body weight	In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)
Anthropometric parameters : waist circumference	waist circumference	In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)
Athropometric parameters : hip circumference	hip circumference	In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)
Body composition parameters characterisation : total body water	Total body water measured by bioimpedancemetry	In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)
Body composition parameters characterisation : body fat	Body fat measured by bioimpedancemetry	In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)
Body composition parameters characterisation : lean mass	Lean mass measured by bioimpedancemetry	In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)
Resting energy metabolism profile : Resting Metabolism Rate	Resting Metabolism Rate (RMR) measured by indirect calorimetry	In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)
Exhaled gases - Dihydrogen	Dihydrogen measured during breath test	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)
Exhaled gases - Methane	Methane measured during breath test	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)
Exhaled gases : Volatile Organic Compounds	Volatile Organic Compounds	Measured at time T-30 minutes of breath test during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)
Gut microbiota composition	Whole genome shotgun sequencing	Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)
Microbiota activity : short chain fatty acids	Short chain fatty acids measured in fecal samples	Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)
Microbiota functionlity	Bacterial enzymes measured in feces	Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)
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)	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)

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe; Unite MetaGenoPolis INRAE
• Investigators: Principal Investigator: Anne-Laure Castell, MD, Centre de recherche en nutrition humaine Rhone-Alpes

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Resistant Starch; Diet; microbiota; Glycemic control; CGMS; SDS; Slowly Digestible Starch; Continuous Glucose Monitoring System; Mean Amplitude of Glucose Excursion; Insulin resistant subjets
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Nutritional and Metabolic Diseases; Insulin Resistance; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates; Polymers; Macromolecular Substances; Polysaccharides; Starch; Glucans; Biopolymers; Dietary Fiber; Resistant Starch
• Other Study ID Numbers: KBE072 / Glymicare

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No