CompletedNCT03289494Updated May 27, 2020

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

An interventional study of Balanced diet high in Slowly Digestible Starch and Balanced diet low in Slowly Digestible Starch in Type2 Diabetes, sponsored by Mondelēz International, Inc.. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by Mondelēz International, Inc. · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 9
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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).

Read the 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.

Conditions studied

Type2 Diabetes

Browse trials for

Diabetes Mellitus, Type 2 9,339

Keywords

Slowly Digestible Starch
SDS
Type 2 diabetes
T2D
Glycemic response
Continuous Glucose Monitoring System
CGMS

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 9 participants (actual)

Study arms

Active comparator
Diet A
Balanced diet high in Slowly Digestible Starch
Other: Balanced diet high in Slowly Digestible Starch
Placebo comparator
Diet B
Balanced diet low in Slowly Digestible Starch
Other: Balanced diet low in Slowly Digestible Starch

Interventions

OtherBalanced 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.
OtherBalanced 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.

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Centre de Recherche en Nutrition Humaine Rhone-Alpe
Pierre-Bénite, 69310, France

References and documents

Publications

Breyton AE, Goux A, Lambert-Porcheron S, Meynier A, Sothier M, VanDenBerghe L, Brack O, Disse E, Laville M, Vinoy S, Nazare JA. Starch digestibility modulation significantly improves glycemic variability in type 2 diabetic subjects: A pilot study. Nutr Metab Cardiovasc Dis. 2021 Jan 4;31(1):237-246. doi: 10.1016/j.numecd.2020.08.010. Epub 2020 Aug 25. PubMed 32988721 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03289494
Lead sponsor: Mondelēz International, Inc.
Collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe, Biofortis Mérieux NutriSciences
Responsible party: Sponsor
First posted: Sep 21, 2017
Start date: Aug 30, 2017
Primary completion: Jul 24, 2018
Completion: Jul 24, 2018
Last update: May 27, 2020

Study contacts

Emmanuel DISSE, MD, PhD

principal investigator · Centre de Recherche en Nutrition Humaine Rhône-Alpes

Martine LAVILLE, MD, PhD

study chair · Centre de Recherche en Nutrition Humaine Rhône-Alpes

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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