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| Name | Class |
|---|---|
| Centre de Recherche en Nutrition Humaine Rhone-Alpe | OTHER |
| Biofortis Mérieux NutriSciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High in SDS | Active Comparator | Balanced diet high in Slowly Digestible Starch |
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| Low in SDS | Placebo Comparator | Balanced diet low in Slowly Digestible Starch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced diet high in Slowly Digestible Starch | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel DISSE, MD, PhD | Centre de Recherche en Nutrition Humaine Rhone-Alpe | Principal Investigator |
| Martine LAVILLE, MD, PhD | Centre de Recherche en Nutrition Humaine Rhone-Alpe | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche en Nutrition Humaine Rhone-Alpes | Pierre-Bénite | 69310 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41092985 | Derived | Chisbert M, Castell AL, Van Den Berghe L, Breyton AE, Feugier N, Cuerq C, Chikh K, Brack O, Laville M, Goux A, Meynier A, Vinoy S, Nazare JA. Optimizing glycemic variability in type 2 diabetes using simple dietary and culinary recommendations to modulate starch digestibility: a randomized controlled trial. Am J Clin Nutr. 2025 Dec;122(6):1591-1601. doi: 10.1016/j.ajcnut.2025.10.007. Epub 2025 Oct 13. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Each participant will be allocated to an intervention arm in a parallel design for 3 months of intervention
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Each diet will be labelled "Diet A" or "Diet B"
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| Balanced diet low in Slowly Digestible Starch | Other | 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. |
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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 |
| D004700 | Endocrine System Diseases |