Evaluation of 2 Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile, in T2D Patients

Sponsor

Mondelēz International, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03289494

Collaborator

Centre de Recherche en Nutrition Humaine Rhone-Alpe (Other), Biofortis Mérieux NutriSciences (Other)

Enrollment

Location

Arms

10.8

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes	Other: Balanced diet high in Slowly Digestible Starch Other: Balanced diet low in Slowly Digestible Starch	N/A

Detailed Description

8 patients with type 2 diabetic patients will be recruited.

Subjets will have 5 visits:

The selection visit (V1) is required to check whether the patients fulfill inclusion and exclusion criteria for the study.

The visit V2 will include randomization, medical check-up and a dietary interview (LogBook supply with explanations for filling and dietary advice cards for the 1st week of diet). The nurse will insert the CGMS and the patient will receive detailed instructions on wearing the sensor and recorder. The patient will leave the research center with a glucometer, the starchy foods and cereal products adapted for its first week of diet and the associated cooking instruction sheets and menus given by the dietician.

During each day of the first experimental diet period, the patient will take at least four blood glucometer readings per day, and will consume the food products according to a menu plan and the cooking instruction sheets given by the dietician, and fill a dietary record.

After 6 days +/- 1 day, the patient will return to the center (Visit V3) to remove the CGMS, bring back the glucometer and the follow-up LogBook. A Medical check-up will also be performed. Compliance will be assessed using the dietary record of the follow-up LogBook and the return of the uneaten products (weighting). A feedback questionnaire will be completed by each patient to have a global assessment of the diet and to evaluate the feasibility of this type of diet over longer periods.

The wash-out period will then last 2 weeks +/- 3 days. Then a new sequence will start. The visit V4 will be similar to visit V2 with: installation of the CGMS, provision of the LogBook and diet specific information for the second period. The glucometer and starchy foods and cereal products will be supplied to the patients.

During each day of this second diet period, patients will be required to consume starchy foods and cereal products according to a menu plan and cooking instructions provided by the dietician, and fill a dietary record. The patient will realize 4 capillary blood glucose control and will fill the information required in the LogBook.

Finally, Visit V5 will be the last visit. It will include, like for visit V3: removal of CGMS, return of glucometer and follow-up LogBook and a medical check-up . Compliance will be assessed using the dietary record of the follow-up LogBook and the return of the uneaten products (weighting). A feedback questionnaire will be completed by patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Each subject will receive two independant weeks of diet intervention, in a crossover designEach subject will receive two independant weeks of diet intervention, in a crossover design

Masking:

Single (Participant)

Masking Description:

Each diet will be labelled "Diet A" or "Diet B"

Primary Purpose:

Prevention

Official Title:

A Pilot Randomized Controlled Trial Evaluating the Effect of Two Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile Measured by Continuous Glucose Monitoring System (CGMS), in Type 2 Diabetic Patients

Actual Study Start Date :

Aug 30, 2017

Actual Primary Completion Date :

Jul 24, 2018

Actual Study Completion Date :

Jul 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Diet A Balanced diet high in Slowly Digestible Starch	Other: Balanced diet high in Slowly Digestible Starch The carbohydrate present in the diet high in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.
Placebo Comparator: Diet B Balanced diet low in Slowly Digestible Starch	Other: Balanced diet low in Slowly Digestible Starch The carbohydrate present in the diet low in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.

Arm

Intervention/Treatment

Active Comparator: Diet A

Balanced diet high in Slowly Digestible Starch

Other: Balanced diet high in Slowly Digestible Starch

The carbohydrate present in the diet high in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.

Placebo Comparator: Diet B

Balanced diet low in Slowly Digestible Starch

Other: Balanced diet low in Slowly Digestible Starch

The carbohydrate present in the diet low in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.

Outcome Measures

Primary Outcome Measures

Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS [minimum 2h to maximum 6h postprandial periods and average value of minimum 3 days to a maximum of 6 days of CGMS record]
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.

Secondary Outcome Measures

Glycemic profile parameters: Minimum glycaemia [minimum 3 days to a maximum of 6 days of CGMS record]
Minimum glycaemia
Glycemic profile parameters: maximum glycaemia [minimum 3 days to a maximum of 6 days of CGMS record]
maximum glycaemia
Glycemic profile parameters: Standard Deviation (SD) from CGMS glycaemia [minimum 3 days to a maximum of 6 days of CGMS record]
Standard Deviation (SD) from CGMS glycaemia
Glycemic profile parameters: Coefficient of Variation (CV) from CGMS glycaemia [minimum 3 days to a maximum of 6 days of CGMS record]
Coefficient of Variation (CV) from CGMS glycaemia
Glycemic profile parameters: MAGE [minimum 3 days to a maximum of 6 days of CGMS record]
Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia
Glycemic profile parameters: MODDs [minimum 3 days to a maximum of 6 days of CGMS record]
Mean Of Daily Differences (MODDs) from CGMS glycaemia
Glycemic profile parameters: MIME [minimum 3 days to a maximum of 6 days of CGMS record]
Mean Indices of Meal Excursions (MIME) from CGMS glycaemia
Glycemic profile parameters: Time in Range [minimum 3 days to a maximum of 6 days of CGMS record]
Mean time spent in the appropriate glycemic range in %
Glycemic profile parameters: ADRR [minimum 3 days to a maximum of 6 days of CGMS record]
Average of Daily Risk Ratio (ADRR) from CGMS glycaemia
Glycemic profile parameters: CONGA [minimum 3 days to a maximum of 6 days of CGMS record]
Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia
Glycemic profile parameters: hyperglycemia durations [minimum 3 days to a maximum of 6 days of CGMS record]
hyperglycemia durations
Glycemic profile parameters: hypoglycemia durations [minimum 3 days to a maximum of 6 days of CGMS record]
hypoglycemia durations
Glycemic profile parameters: mean glycemic value [minimum 3 days to a maximum of 6 days of CGMS record]
mean glycemic value on relevant time interval
Glycemic profile parameters: incremental AUC [minimum 3 days to a maximum of 6 days of CGMS record]
incremental AUC calculated on relevant time interval
Glycemic profile parameters: total AUC [minimum 3 days to a maximum of 6 days of CGMS record]
total AUC calculated on relevant time interval, calculated using the trapezoid rule and including all area below the curve
Glycemic profile parameters: kinetics [minimum 3 days to a maximum of 6 days of CGMS record]
Daylong glycaemia kinetics
Compliance parameters: mean SDS ingestion [maximum of 6 days of LogBook record]
mean SDS ingestion by type of meal and per day
Dietary intake evaluation [After 1 week intervention diet]
Dietary record analysis, in g of macronutrient intake
Dietary record evaluation [After 1 week intervention diet]
Dietary record analysis, in % of total energy intake
Charaterisation of acceptability to H-SDS diet in free living conditions [After 1 week intervention diet]
Feedback questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient able to understand the study information and providing written consents 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 6,5% and 8,5%
Bi-therapy associating metformin and sitagliptin at stable dose for at least 1 month
T2D volunteer without insulin therapy or GLP-1 analogues
Patient with BMI ranging between 22 and 37 kg/m2 (bounds included)
Patient with stable body weight over the past three months (+/- 5 % of body weight)
Patient accepting to change its diet for two weeks
Patient not suffering from intolerance or allergy
Patient regularly consuming products proposed in the study
Patient regularly consuming 3 main meals per day
Sedentary behavior or stable regular 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 assurance

Exclusion Criteria:

General criteria:
Patient under legal protection measure
Patient deprived of liberty by a court or an administrative decision
Patient currently participating in another study or being in the exclusion period of another study
Volunteer that exceed the financial compensation allowed per year for participating in research programs
Biological criteria:
Gamma-GT > 2.5 times above the norm (>160 UI/L)
ASAT > 2.5 times above the norm (>85 UI/L)
ALAT > 2.5 times above the norm (>137.5 UI/L)
Triglycerides > 4 g/L
LDL-cholesterol > 1.90 g/L
CRP > 15 mg/L
Hemoglobin < 120 mg/dL
Other biological abnormality with clinical significant relevance according to the investigator
Therapeutic and medical criteria:
Patient with type 1 diabetes
T2D treatment other than metformin and sitagliptin
Patient with past bariatric surgery
Patient with medical history of endocrine diseases who may interfere with glucose metabolism according to the investigator (such as thyroid dysfunction, acromegaly, hypercorticism…)
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 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 willing to lose weight
Patient with eating disorders (e.g. anorexia nervosa and bulimia) according to the investigator
Patient without stable dietary habits or with specific diet (vegetarian, vegan,…) according to the investigator
Patient who smokes
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
Patient consuming in the two previous months regularly corticoids, anorectics, adrenergic drugs, beta-blocking drugs, antiplatelet agent (like aspirin) or other drugs or supplement that should impact glucose metabolism (other than metformin or DPP4 inhibitor) in the investigator's opinion
Adhesive plaster skin allergy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de Recherche en Nutrition Humaine Rhone-Alpe	Pierre-Bénite		France	69310

Sponsors and Collaborators

Mondelēz International, Inc.
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Biofortis Mérieux NutriSciences

Investigators

Principal Investigator: Emmanuel DISSE, MD, PhD, Centre de Recherche en Nutrition Humaine Rhône-Alpes
Study Chair: Martine LAVILLE, MD, PhD, Centre de Recherche en Nutrition Humaine Rhône-Alpes