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| Name | Class |
|---|---|
| Centre de Recherche en Nutrition Humaine Rhone-Alpe | OTHER |
| Unite MetaGenoPolis INRAE | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High SDS-RS diet | Active Comparator | Balanced diet containing high levels of Slowly digestible Starch (SDS) and Resistant Starch (RS) |
|
| Low SDS-RS diet | Placebo Comparator | Balanced diet containing low levels of Slowly digestible Starch (SDS) and Resistant Starch (RS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced diet high in Slowly Digestible Starch and Resistant Starch | Other | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
• General criteria:
Food-related criteria:
Exclusion Criteria:
General criteria:
Biological criteria:
Population-related criteria :
Therapeutic and medical criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie-Anne Nazare, PhD | Contact | +33 4 78 86 29 81 | julie-anne.nazare@univ-lyon1.fr | |
| Alexandra Meynier, PhD | Contact | +33 1 83 11 45 68 | alexandra.meynier@mdlz.com |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Laure Castell, MD | Centre de Recherche en Nutrition Humaine Rhone-Alpe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche en Nutrition Humaine Rhone-Alpes | Recruiting | Lyon | 69310 | France |
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This will be a single blind, randomized, controlled 2 months intervention study with parallel design
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Each diet will be labelled "Diet A" or "Diet B" with both diets containing similar categories of products
|
| Balanced diet low in Slowly Digestible Starch and Resistant Starch | Other | 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 |
|
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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) |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000084922 | Resistant Starch |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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