Clinical trial NCT04905589: Medium Chain Triglycerides (MCT) and Whey Protein Isolate (WPI) for Type 2 Diabetes Patients (Combine)
Official title: Effect of Combined Intake of Medium Chain Triglycerides (MCT) At Breakfast and Whey Protein Isolate (WPI) Preload At Lunch and Dinner on Diurnal Glucose and Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open-label - randomization-concealed trial randomized in a 1:1:1 ratio
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Diurnal glucose Incremental area under curve (iAUC) concentrations
timeFrame: 115 days
Secondary outcomes:
measure: Glucose concentrations
timeFrame: 115 days
measure: Area under curve (AUC) glucose
timeFrame: 115 days
measure: Incremental area under curve (iAUC) glucose
timeFrame: 115 days
measure: Visual Analogue Scale (VAS) questionnaire
timeFrame: 115 days
measure: Glucose mean
timeFrame: 115 days
measure: Glucose Incremental area under curve (iAUC)
timeFrame: 115 days
measure: Leptin mean
timeFrame: 115 days
measure: Leptin Incremental area under curve (iAUC)
timeFrame: 115 days
measure: Gastric inhibitory polypeptide (GIP) - GLP-1 mean
timeFrame: 115 days
measure: Glucagon-like peptide-1 (GLP-1) mean
timeFrame: 115 days
measure: Gastric inhibitory polypeptide (GIP) - Incremental area under curve (iAUC)
timeFrame: 115 days
measure: Glucagon-like peptide-1 (GLP-1) Incremental area under curve (iAUC)
timeFrame: 115 days
measure: Peptide tyrosine tyrosine (PYY) mean
timeFrame: 115 days
measure: Peptide tyrosine tyrosine (PYY) Incremental area under curve (iAUC)
timeFrame: 115 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Professor Kostas Tsintzas
role: PRINCIPAL_INVESTIGATOR
References: