Medium Chain Triglycerides (MCT) and Whey Protein Isolate (WPI) for Type 2 Diabetes Patients (Combine)

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: BetaQuik™; Other: Iso-voluminous water; Dietary Supplement: WheyBasics

• Registration Number: NCT04905589
• Lead Sponsor: Société des Produits Nestlé (SPN)

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

Study Timeline

• Study Start: 2021-04-30
• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-27
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ARM B	Iso-voluminous water	Subsequent order of intake : MCT in liquid form (75 ml of BetaQuik™), breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner
ARM B	BetaQuik™	Subsequent order of intake : MCT in liquid form (75 ml of BetaQuik™), breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner
ARM C	BetaQuik™	Subsequent order of intake: MCT in liquid form (75 ml of BetaQuik™), breakfast, WPI in liquid from (12.5g of WheyBasics in 200ml water), lunch, WPI in liquid from (12.5g of WheyBasics in 200ml water)), dinner
ARM A	Iso-voluminous water	Subsequent order of intake : Iso-voluminous water, breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner
ARM C	WheyBasics	Subsequent order of intake: MCT in liquid form (75 ml of BetaQuik™), breakfast, WPI in liquid from (12.5g of WheyBasics in 200ml water), lunch, WPI in liquid from (12.5g of WheyBasics in 200ml water)), dinner

Primary Outcome Measures

Name	Time	Method
Diurnal glucose Incremental area under curve (iAUC) concentrations	115 days	Constant glucose monitoring (CGM) comparing treatment regimen A-B-C

Secondary Outcome Measures

Name	Time	Method
Glucose concentrations	115 days	Mean, standard deviation and coefficient of variation of 24h glucose concentration as 24h 24h assessed by CGM
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
Leptin Incremental area under curve (iAUC)	115 days	Arterialised blood concentration
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

Trial Locations

Locations (1)

University of Nottingham; 🇬🇧 Nottingham, United Kingdom