Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients

This is a monocentric, randomized, single-blind and controlled study with a parallel design (2 arms). The research hypothesis is that the diet high in Slow Digestible Starch (SDS) content (H-SDS) will lower the daylong glycemic response and improve the glycemic control just as metabolic, inflammatory, cardiovascular and oxidative stress parameters in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS). The hypothesis is that these differences in glycemic response and in metabolic, inflammatory, cardiovascular and oxidative stress parameters response can be observed after 3 months of diet.

Study Overview

• Status: Recruiting
• Conditions: Type2 Diabetes
• Intervention / Treatment: Other: Balanced diet high in Slowly Digestible Starch; Other: Balanced diet low in Slowly Digestible Starch

Detailed Description

This is a monocentric, randomized, single-blind and controlled study with a parallel design (2 arms). The research hypothesis is that the diet high in Slow Digestible Starch (SDS) content (H-SDS) will lower the daylong glycemic response and improve the glycemic control just as metabolic, inflammatory, cardiovascular and oxidative stress parameters in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS). The hypothesis is that these differences in glycemic response and in metabolic, inflammatory, cardiovascular and oxidative stress parameters response can be observed after 3 months of diet.

80 patients with type 2 diabetes will be recruited.

Subjects will have 11 visits:

V0 = selection visit: check whether the patients fulfill inclusion and exclusion criteria for the study.

Visit V1 = CGMS insertion on usual lifestyle without any changes in his/her diet. This is the Run-in period.

Visit V2 (6 days +/- 1 day) = CGMS removal and randomization according to sex, HbA1c and MAGE.

Visit V3 = first metabolic day: medical check-up, dietary interview, indirect calorimetry, impedancemetry measurements and FlexMeal challenge test with 5h follow up (blood samples). CGMS insertion with detailed dietetic instructions according to their allocated group (adapted food provisions).

Visit V4 (6 days +/- 1 day) = CGMS removal. Arterial Endothelial Function (AEF) measurement. Adapted food provisions.

Visit V5 = Adapted food provisions.

Visit V6 = medical check-up, dietary interview, CGMS insertion and baseline blood measurements. Adapted food provisions.

Visit V7 (6 days +/- 1 day) = CGMS removal. Arterial Endothelial Function (AEF) measurement. Adapted food provisions.

Visit V8 = Adapted food provisions.

Visit V9 = CGMS insertion. Arterial Endothelial Function (AEF) measurement. Adapted food provisions.

Visit V10 (6 days +/- 1 day) = second metabolic day: medical check-up, dietary interview, indirect calorimetry, impedancemetry measurements and FlexMeal challenge test with 5h follow up (blood samples). CGMS removal. Feedback questionnaire.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• 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: Aurélie Goux, PhD; Phone Number: +33 1 83 11 46 20; Email: aurelie.goux@mdlz.com

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Recruiting
    • Centre de Recherche en Nutrition Humaine Rhône-Alpes
    • Contact: Anne-Esther BREYTON; Phone Number: + 33 4 78 86 29 81; Email: amidon@crnh-rhone-alpes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient able to understand the study information and providing written consent for his/her participation to the study
• Male or female
• Patient undergoing medical examination during the selection visit
• Patient aged between 18 and 75 years old (bounds included)
• T2D volunteer with HbA1c between 7% and 8,5% without signs of insulinopenia according to the investigator
• Patient with BMI ranging between 25 and 40 kg/m2 (bounds included)
• Patient with stable body weight over the past three months (+/- 5 % of body weight)
• Patient accepting to change its diet for three months
• Patient not suffering from food intolerance or allergy
• Patient regularly consuming products proposed in the study
• Patient agreeing to consume 3 main meals per day without extra-prandial carbohydrates intakes
• Sedentary behavior or stable predicted physical activity during the study
• Patient not presenting any disease during the medical examination / interview which could interfere with the results of the study according to the investigator
• Patient covered by health insurance
• Patient accepting to have short nails on his/her 2 forefingers

Exclusion Criteria:

• Patient under legal protection measure
• Patient deprived of liberty by a court or an administrative decision
• Patient currently participating in another study or being in the exclusion period of another study
• Volunteer that exceed the financial compensation allowed per year for participating in research programs
• Gamma-GT > 2.5 times above the norm (>160 UI/L)
• ASAT > 2.5 times above the norm (>85 UI/L)
• ALAT > 2.5 times above the norm (>137.5 UI/L)
• Triglycerides > 4 g/L
• LDL-cholesterol > 1.90 g/L
• CRP > 15 mg/L
• Hemoglobin < 120 mg/dL
• eGRF (estimated glomerular filtration rate) < 45 ml/min
• Other biological abnormality with clinical significant relevance according to the investigator
• Patient with type 1 diabetes, post pancreatectomy or post transplant diabetes, MODY diabetes, mitochondrial diabetes, iatrogenic diabetes
• T2D volunteer with any other anti-diabetic treatment other than metformin: insulin therapy, GLP-1 analogues, acarbose, sulphonylureas, repaglinide, SGLT2 agonists,…
• Patient consuming in the two previous months regularly corticoids, beta-blocking drugs or immunosuppressing drugs
• Patient with hemoglobin pathology
• Patient with medical history of hemoglobinopathies (thalassemia, drepanocytosis…)
• Patient with past bariatric surgery
• Patient with medical history of endocrine diseases who may interfere with glucose metabolism according to the investigator (such as hyperthyroidism, acromegaly, hypercorticism…)
• Patient treated with anticoagulants
• Patient with a pace-maker
• Uncontrolled high blood pressure defined by Systolic blood pressure > 150 mmHg or Diastolic blood pressure > 100 mmHg
• Evidence of any other unstable or untreated clinically significant immunological, neoplasic, endocrine, haematological, gastrointestinal, hepatic, neurological or psychiatric abnormalities or medical disease with clinical significant relevance according to the investigator
• Pregnant women or willing to become pregnant or lactating women
• Women of childbearing age without an efficient contraceptive method according to the investigator
• Patient under a restrictive diet or with a planned weight loss program during the study
• Patient with severe eating disorders (e.g. anorexia nervosa, binge eating disorder and bulimia) according to the investigator
• Patient without stable dietary habits or with specific diet (vegetarian, vegan, gluten-free…) according to the investigator
• Patient who smokes more than 5 cigarettes per day
• Patient regularly consuming more than 20 g/day of alcohol. Consumption of more than 3 alcoholic beverages per day is recognized as excessive. An alcoholic beverage is: 30 mL of spirituous, 120 mL of wine or 330 mL of beer
• Patient regularly consuming recreational drugs
• Adhesive plaster skin allergy
• Claustrophobic patient
• Patient willing to take the plane during the CGMS periods

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: High in SDS; Balanced diet high in Slowly Digestible Starch	Other: Balanced diet high in Slowly Digestible Starch; The carbohydrates present in high Slowly Digestible Starch diet were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during three months.; Other Names: Diet A; H-SDS
PLACEBO_COMPARATOR: Low in SDS; Balanced diet low in Slowly Digestible Starch	Other: Balanced diet low in Slowly Digestible Starch; The carbohydrates present in low-Slowly Digestible Starch diet were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during three months.; Other Names: Diet B; L-SDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAGE comparison following 3 months of intake of a diet either high or low in SDS	Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia	Minimum 3 days to a maximum of 6 days of CGMS record

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemia iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day	Glycemia iAUC	5 hours post standard challenge test during visit 3
Insulin iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day	Insulin iAUC	5 hours post standard challenge test during visit 3
GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day	GLP1 iAUC	5 hours post standard challenge test during visit 3
Inflammatory status comparison during the first metabolic day : CRPus concentration	CRPus	At a basal state during visit 3
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : TNFa iAUC	TNFa iAUC	5 hours post standard challenge test during visit 3
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL6 iAUC	IL6 iAUC	5 hours post standard challenge test during visit 3
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL1Ra iAUC	IL1Ra iAUC	5 hours post standard challenge test during visit 3
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL18 iAUC	IL18 iAUC	5 hours post standard challenge test during visit 3
Glycemic impacts comparison following the intake of a diet either high or low in SDS during the time course of the study	Glycemia concentration	At a basal state during visit 3, visit 6 and visit 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	At a basal state during visit 3, visit 6 and visit 10
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 concentration	At a basal state during visit 3, visit 6 and visit 10
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	At a basal state during visit 3, visit 6 and visit 10
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	At a basal state during visit 3, visit 6 and visit 10
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	At a basal state during visit V3, V6 and V10
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	At a basal state during visit 3, visit 6 and visit 10
Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : MDA concentration	Malonaldehyde : MDA concentration	At a basal state during visit 3, visit 6 and visit 10
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 concentration	At a basal state during visit 3, visit 6 and visit 10
Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : MCP1 concentration	MCP1 concentration	At a basal state during visit 3, visit 6 and visit 10
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	At a basal state during visit 3, visit 6 and visit 10
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	At a basal state during visit 3, visit 6 and visit 10
Glycemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day	Glycemia iAUC	5 hours post standard challenge test during visit 10
Insulinemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day	Insulin iAUC	5 hours post standard challenge test during visit 10
GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the second metabolic day	GLP1 iAUC	5 hours post standard challenge test during visit 10
Inflammatory impacts comparison following 3 months of intake of a diet either high or low in SDS : CRPus concentration	CRPus concentration	At a basal state during visit 10
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 10
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 10
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 10
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 10
Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : MCP1 concentration	MCP1 concentration	After 3 months consumption of the diet
Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : sICAM concentration	sICAM concentration	After 3 months consumption of the diet
Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : sVCAM concentration	sVCAM concentration	After 3 months consumption of the diet
Oxydative stress characterisation following the intake of a diet either high or low in SDS : MDA concentration	Malonaldehyde : MDA concentration	After 3 months consumption of the diet
Oxydative stress characterisation following the intake of a diet either high or low in SDS : Urinary isoprostanes concentration	Urinary isoprostanes concentration	After 3 months consumption of the diet
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
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MAGE	Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : TIR	Time In Range (TIR) from CGMS glycaemia	minimum 3 days to a maximum of 6 days of CGMS record
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	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
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
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : CV	Coefficient of Variation (CV) from CGMS glycaemia	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
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
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : SD	Standard Deviation (SD) from CGMS glycaemia	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
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
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MIME	Mean Indices of Meal Excursions (MIME) from CGMS glycaemia	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
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
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MODD	Mean Of Daily Differences (MODD) from CGMS glycaemia	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
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
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : CONGA	Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
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
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : ADRR	Average Daily Risk Range (ADRR) from CGMS glycaemia	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
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
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : LGBI	Low Blood Glucose Index (LGBI) from CGMS glycaemia	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
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
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : HGBI	High Blood Glucose Index (HGBI) from CGMS glycaemia	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
Mean daylong incremental Area Under the Curve (iAUC), measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study	The iAUC 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 min to 360 min postprandial during the CGMS record periods (from visit 3 to visit 4, from visit 6 to visit 7 and from visit 9 to visit 10)
Mean daylong total Area Under the Curve (tAUC), 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 min to 360 min postprandial during the CGMS record periods (from visit 3 to visit 4, from visit 6 to visit 7 and from visit 9 to visit 10)
Compare diabetes follow-up markers during the first metabolic day : HbA1c	Hba1c concentration	At the basal state during visit 3
Compare diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : HbA1c concentration	Hba1c	At a basal state, during visit 3, visit 6 and visit 10
Compare diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : HbA1c concentration	Hba1c	After 3 months consumption of the diet, at the basal state
Compare Diabetes follow-up markers during the first metabolic day : Fructosamine concentration	Fructosamine	At the basal state during visit 3
Compare Diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : fructosamine concentration	Fructosamine	At a basal state, during visit 3, visit 6 and visit 10
Compare Diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : Fructosamine concentration	Fructosamine	After 3 months consumption of the diet, at the basal state
Compare Diabetes follow-up markers during the first metabolic day : Glycated Albumin concentration	Glycated albumin	At the basal state during visit 3
Compare Diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : glycated albumin concentration	Glycated albumin	At a basal state, during visit 3, visit 6 and visit 10
Compare Diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : Glycated Albumin concentration	Glycated albumin	After 3 months consumption of the diet, at the basal state
Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : RHI	Reactive Hyperemia (RHI)	At a basal state during visit 4, visit 7 and visit 9
Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : AI	Augmentation Index (AI)	At a basal state during visit 4, visit 7 and visit 9
Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : HRV	Heart Rate Variability (HRV)	At a basal state during visit 4, visit 7 and visit 9
Anthropometry parameters characterisation during the first metabolic day : height	Height	At baseline during visit 3
Anthropometry parameters characterisation during the first metabolic day : body weight	body weight	At baseline during visit 3
Anthropometry parameters characterisation during the first metabolic day : waist circumference	waist circumference	At baseline during visit 3
Anthropometry parameters characterisation during the first metabolic day : hip circumference	hip circumference	At baseline during visit 3
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : height	Height	At baseline during visit 3, visit 6 and visit 10
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : body weight	body weight	At baseline during visit 3, visit 6 and visit 10
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : waist circumference	waist circumference	At baseline during visit 3, visit 6 and visit 10
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : hip circumference	hip circumference	At baseline during visit 3, visit 6 and visit 10
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : height	Height	At baseline during visit 10
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : body weight	body weight	At baseline during visit 10
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : waist circumference	waist circumference	At baseline during visit 10
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : hip circumference	hip circumference	At baseline during visit 10
Body composition parameters characterisation during the first metabolic day: total body water	Total body water measured by bioimpedancemetry	At baseline during visit 3
Body composition parameters characterisation during the first metabolic day: body fat	Body fat measured by bioimpedancemetry	At baseline during visit 3
Body composition parameters characterisation during the first metabolic day: lean mass.	Lean mass measured by bioimpedancemetry	At baseline during visit 3
Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : total body water	Total body water measured by bioimpedancemetry	At baseline during visit 10
Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : body fat	Body fat measured by bioimpedancemetry	At baseline during visit 10
Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : lean mass	Lean mass measured by bioimpedancemetry	At baseline during visit 10
Resting energy metabolism profile during the first metabolic day: Resting Metabolism Rate	Resting Metabolism Rate (RMR)	At baseline during visit 3
Resting energy metabolism profile following the 3 months consumption of a diet either high or low in SDS : Resting Metabolism Rate	Resting Metabolism Rate (RMR)	At baseline during visit 10
Diabetic glycemic variability characterisation following the 3 months consumption of a diet either high or low in SDS	Percent of subjects reaching the target for HbA1C, TIR and CV	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days
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)	After each CGMS record periods, ie : at visit 4, visit 7 and visit 10
Characterisation of acceptability to H-SDS diet in free living conditions	Feedback questionnaire	After 3 months consumption of the diet, at visit 10
Characterisation of the percent of compliance to H-SDS diet in free living conditions	Table of compliance in the volunteer's notebook. Subjects will have to fulfill it after each meal during the study period	After 3 months consumption of the diet

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe; Biofortis Mérieux NutriSciences
• Investigators: Principal Investigator: Emmanuel DISSE, MD, PhD, Centre de Recherche en Nutrition Humaine Rhône-Alpes; Study Chair: Martine LAVILLE, MD, PhD, Centre de Recherche en Nutrition Humaine Rhône-Alpes

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 25, 2019
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (ACTUAL): February 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Diet; T2D; MAGE; CGMS; Glycemic response; SDS; Slowly Digestible Starch; Continuous Glucose Monitoring System; Mean Amplitude of Glucose Excursion
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: KBE045

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