Type 2 Diabetes
Conditions
Brief summary
Evaluation of effect on diurnal glycaemia following consumption of MCT and whey protein in patients with type 2 diabetes
Detailed description
The purpose of this study (Combine) is to evaluate the effects of Combined Intake of Medium chain triglycerides (MCT) at breakfast and whey protein isolate (WPI) preload at lunch and dinner for patients with type 2 diabetes
Interventions
DIETARY_SUPPLEMENTBetaQuik™
MCT (Medium chain triglycerides)
DIETARY_SUPPLEMENTWheyBasics
Whey Protein Isolate
OTHERIso-voluminous water
Iso-voluminous Water as comparitor to Betaquik or WheyBasics
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open-label - randomization-concealed trial randomized in a 1:1:1 ratio
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects, 25 to 65 years of age, inclusive. 2. Subjects with a BMI of ≤ 40kg/m2. 3. Established diagnosis of Type 2 diabetes mellitus (T2DM), documented by either HbA1c 6.5 -10.0% or active therapy with metformin at a daily dose of up to 3000 mg at screening. 4. Willing and able to sign written informed consent prior to study entry. 5. Subjects with laboratory parameters within normal range, or showing no clinically relevant deviations, as judged by the investigator. 6. Willing and able to comply with the requirements of the study protocol.
Exclusion criteria
1. Fasting blood glucose \>11mmol/L at screening. 2. Elevated liver transaminases \> 3 Upper limit of normal at screening. 3. Ongoing or recent (i.e. \< 3month) insulin therapy. 4. Ongoing or recent (i.e. \< 3month) GLP-1 therapy. 5. Ongoing or recent (i.e. \< 3month) treatment with any oral or injectable glucose-lowering drug other than metformin. 6. Ongoing or recent weight loss interventions (e.g. dietary weight loss programmes) or any history of bariatric surgery. 7. Ongoing treatment with anorectic drugs, steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption. 8. Major medical/surgical event requiring hospitalization in the last 3 months. 9. Known allergy and intolerance to product components. 10. Alcohol intake higher than 4 units per day in line with National Health Service guidelines. 11. History of regular smoking (daily or most days in a week) or use of nicotine products (3 or more nicotine containing products). 12. Have a hierarchical link with the research team members. 13. Subjects who have been dosed in another clinical trial with any investigational drug/new chemical entity within 3 months or 5 half-lives (whichever is longer) prior to screening, or subjects currently participating in any investigational trial. 14. Positive pregnancy test at screening for women of child-bearing potential. 15. Subject who, in the judgment of the investigator, is likely to be noncompliant or uncooperative during the study due to language barrier, poor mental development or any other reason. 16. Subjects with fasting blood glucose that is not within 20% of the value at the previous study visit. Note: In such cases, subjects can come in on another day within the visit window at the discretion of the investigator, however, subjects will be discontinued if the same observation is made at the new visit. 17. Evidence of eating disorders and regularly skipping breakfast and dinner. 18. Current or recent history (in last 3 months) of clinically significant gastrointestinal, liver, cardiovascular, clotting, metabolic or endocrine disorders, apart from T2DM, that in the opinion of the investigator might put the subject at risk by entering the study or interfere with the aims of the study. 19. Total score of ≥ 20 on the Eating Attitude Test (EAT-26) at the screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diurnal glucose Incremental area under curve (iAUC) concentrations | 115 days | Constant glucose monitoring (CGM) comparing treatment regimen A-B-C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under curve (AUC) glucose | 115 days | 24h assessed by CGM |
| Incremental area under curve (iAUC) glucose | 115 days | 24h assessed by CGM |
| Visual Analogue Scale (VAS) questionnaire | 115 days | 100-point VAS on satiety |
| Glucose mean | 115 days | Arterialised blood concentration |
| Glucose Incremental area under curve (iAUC) | 115 days | Arterialised blood concentration |
| Leptin mean | 115 days | Arterialised blood concentration |
| Glucose concentrations | 115 days | Mean, standard deviation and coefficient of variation of 24h glucose concentration as 24h 24h assessed by CGM |
| Gastric inhibitory polypeptide (GIP) - GLP-1 mean | 115 days | Arterialised blood concentration |
| Glucagon-like peptide-1 (GLP-1) mean | 115 days | Arterialised blood concentration |
| Gastric inhibitory polypeptide (GIP) - Incremental area under curve (iAUC) | 115 days | Arterialised blood concentration |
| Glucagon-like peptide-1 (GLP-1) Incremental area under curve (iAUC) | 115 days | Arterialised blood concentration |
| Peptide tyrosine tyrosine (PYY) mean | 115 days | Arterialised blood concentration |
| Peptide tyrosine tyrosine (PYY) Incremental area under curve (iAUC) | 115 days | Arterialised blood concentration |
| Leptin Incremental area under curve (iAUC) | 115 days | Arterialised blood concentration |
Countries
United Kingdom
Outcome results
None listed