Type2 DiabetesNCT03847701
Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients
A study testing Balanced diet high in Slowly Digestible Starch and Balanced diet low in Slowly Digestible Starch in people with Type2 Diabetes, run by Mondelēz International, Inc. at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Balanced diet high in Slowly Digestible Starch and Balanced diet low in Slowly Digestible Starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2019to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine Rhone-Alpes
Pierre-Bénite, 69310
About this study
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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- Balanced diet high in Slowly Digestible Starch, Balanced diet low in Slowly Digestible Starch
- Keywords
- Slowly Digestible Starch, SDS, Type 2 diabetes, T2D, Glycemic response, Continuous Glucose Monitoring System, CGMS, Diet, MAGE, Mean Amplitude of Glucose Excursion
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced diet high in Slowly Digestible StarchOther
Also called Diet A, H-SDS
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.
Balanced diet low in Slowly Digestible StarchOther
Also called Diet B, L-SDS
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.
| Study group | Role | What they receive |
|---|---|---|
| High in SDS | Active comparator | Balanced diet high in Slowly Digestible Starch Receives: Other: Balanced diet high in Slowly Digestible Starch |
| Low in SDS | Placebo comparator | Balanced diet low in Slowly Digestible Starch Receives: Other: Balanced diet low in Slowly Digestible Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Minimum 3 days to a maximum of 6 days of CGMS record
Secondary outcomes (91)
Glycemia iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day
Glycemia iAUC
Measured: 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
Measured: 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
Measured: 5 hours post standard challenge test during visit 3
Inflammatory status comparison during the first metabolic day : CRPus concentration
CRPus
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: After 3 months consumption of the diet, at the basal state
Compare Diabetes follow-up markers during the first metabolic day : Fructosamine concentration
Fructosamine
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At a basal state during visit 4, visit 7 and visit 9
Anthropometry parameters characterisation during the first metabolic day : height
Height
Measured: At baseline during visit 3
Anthropometry parameters characterisation during the first metabolic day : body weight
body weight
Measured: At baseline during visit 3
Anthropometry parameters characterisation during the first metabolic day : waist circumference
waist circumference
Measured: At baseline during visit 3
Anthropometry parameters characterisation during the first metabolic day : hip circumference
hip circumference
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline during visit 10
Body composition parameters characterisation during the first metabolic day: total body water
Total body water measured by bioimpedancemetry
Measured: At baseline during visit 3
Body composition parameters characterisation during the first metabolic day: body fat
Body fat measured by bioimpedancemetry
Measured: At baseline during visit 3
Body composition parameters characterisation during the first metabolic day: lean mass.
Lean mass measured by bioimpedancemetry
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline during visit 10
Resting energy metabolism profile during the first metabolic day: Resting Metabolism Rate
Resting Metabolism Rate (RMR)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: After 3 months consumption of the diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start25 Jun 2019
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will be allocated to an intervention arm in a parallel design for 3 months of intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpe, Biofortis Mérieux NutriSciences
- Responsible party
- Sponsor
- Investigators
- Emmanuel DISSE, MD, PhD, Principal investigator, Centre de Recherche en Nutrition Humaine Rhone-AlpeMartine LAVILLE, MD, PhD, Study chair, Centre de Recherche en Nutrition Humaine Rhone-Alpe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847701
- Sponsor's protocol ID
- KBE045
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2019
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41092985
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT03847701
- Acronym / sponsor ID
- KBE045
- Conditions
- Type2 Diabetes
- Keywords
- Slowly Digestible Starch, SDS, Type 2 diabetes, T2D, Glycemic response, Continuous Glucose Monitoring System, CGMS, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpe, Biofortis Mérieux NutriSciences
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will be allocated to an intervention arm in a parallel design for 3 months of intervention
| Arm | Type | Receives |
|---|---|---|
| High in SDS | Active comparator | Other: Balanced diet high in Slowly Digestible StarchBalanced diet high in Slowly Digestible Starch |
| Low in SDS | Placebo comparator | Other: Balanced diet low in Slowly Digestible StarchBalanced diet low in Slowly Digestible Starch |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (35 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balanced diet high in Slowly Digestible StarchAlso: Diet A, H-SDSThe 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 | High in SDS |
| Balanced diet low in Slowly Digestible StarchAlso: Diet B, L-SDSThe 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 | Low in SDS |
Primary outcome
MAGE comparison following 3 months of intake of a diet either high or low in SDS
Time frame: Minimum 3 days to a maximum of 6 days of CGMS record
Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia
91 secondary outcomes
Glycemia iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day
Time frame: 5 hours post standard challenge test during visit 3
Insulin iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day
Time frame: 5 hours post standard challenge test during visit 3
GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day
Time frame: 5 hours post standard challenge test during visit 3
Inflammatory status comparison during the first metabolic day : CRPus concentration
Time frame: At a basal state during visit 3
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : TNFa iAUC
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 hours post standard challenge test during visit 10
Insulinemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day
Time frame: 5 hours post standard challenge test during visit 10
GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the second metabolic day
Time frame: 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
Time frame: At a basal state during visit 10
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : TNFa iAUC
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After 3 months consumption of the diet
Oxydative stress characterisation following the intake of a diet either high or low in SDS : MDA concentration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 frame: 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 frame: 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
Time frame: 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
Time frame: 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
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 41092985Chisbert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel DISSE, MD, PhD principal investigator
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Martine LAVILLE, MD, PhD study chair
Centre de Recherche en Nutrition Humaine Rhone-Alpe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balanced diet high in Slowly Digestible Starch and Balanced diet low in Slowly Digestible Starch in people with Type2 Diabetes, run by Mondelēz International, Inc. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAGE comparison following 3 months of intake of a diet either high or low in SDS (time frame: Minimum 3 days to a maximum of 6 days of CGMS record). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03847701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.