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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2022-08-01

Brief Summary

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Evaluation of effect on diurnal glycaemia following consumption of MCT and whey protein in patients with type 2 diabetes

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Detailed Description

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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

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Open-label - randomization-concealed trial randomized in a 1:1:1 ratio

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ARM A

Subsequent order of intake :

Iso-voluminous water, breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner

Group Type PLACEBO_COMPARATOR

Iso-voluminous water

Intervention Type OTHER

Iso-voluminous Water as comparitor to Betaquik or WheyBasics

ARM B

Subsequent order of intake :

MCT in liquid form (75 ml of BetaQuik™), breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner

Group Type ACTIVE_COMPARATOR

BetaQuik™

Intervention Type DIETARY_SUPPLEMENT

MCT (Medium chain triglycerides)

Iso-voluminous water

Intervention Type OTHER

Iso-voluminous Water as comparitor to Betaquik or WheyBasics

ARM C

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

Group Type ACTIVE_COMPARATOR

BetaQuik™

Intervention Type DIETARY_SUPPLEMENT

MCT (Medium chain triglycerides)

WheyBasics

Intervention Type DIETARY_SUPPLEMENT

Whey Protein Isolate

Interventions

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BetaQuik™

MCT (Medium chain triglycerides)

Intervention Type DIETARY_SUPPLEMENT

WheyBasics

Whey Protein Isolate

Intervention Type DIETARY_SUPPLEMENT

Iso-voluminous water

Iso-voluminous Water as comparitor to Betaquik or WheyBasics

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No