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

Study Overview
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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

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

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: BetaQuik™
* Dietary Supplement: WheyBasics
* Other: Iso-voluminous water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, 25 to 65 years of age, inclusive. Subjects with a BMI of ≤ 40kg/m2. 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. Willing and able to sign written informed consent prior to study entry. Subjects with laboratory parameters within normal range, or showing no clinically relevant deviations, as judged by the investigator. Willing and able to comply with the requirements of the study protocol. Exclusion Criteria: Fasting blood glucose >11mmol/L at screening. Elevated liver transaminases > 3 Upper limit of normal at screening. Ongoing or recent (i.e. < 3month) insulin therapy. Ongoing or recent (i.e. < 3month) GLP-1 therapy. Ongoing or recent (i.e. < 3month) treatment with any oral or injectable glucose-lowering drug other than metformin. Ongoing or recent weight loss interventions (e.g. dietary weight loss programmes) or any history of bariatric surgery. Ongoing treatment with anorectic drugs, steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption. Major medical/surgical event requiring hospitalization in the last 3 months. Known allergy and intolerance to product components. Alcohol intake higher than 4 units per day in line with National Health Service guidelines. History of regular smoking (daily or most days in a week) or use of nicotine products (3 or more nicotine containing products). Have a hierarchical link with the research team members. 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. Positive pregnancy test at screening for women of child-bearing potential. 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. 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. Evidence of eating disorders and regularly skipping breakfast and dinner. 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. Total score of ≥ 20 on the Eating Attitude Test (EAT-26) at the screening visit.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Open-label - randomization-concealed trial randomized in a 1:1:1 ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: ARM A<br>Subsequent order of intake : Iso-voluminous water, breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner | Other: Iso-voluminous water<br>* Iso-voluminous Water as comparitor to Betaquik or WheyBasics<br>|
| Active Comparator: ARM B<br>Subsequent order of intake : MCT in liquid form (75 ml of BetaQuik™), breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner | Dietary Supplement: BetaQuik™<br>* MCT (Medium chain triglycerides)<br>Other: Iso-voluminous water<br>* Iso-voluminous Water as comparitor to Betaquik or WheyBasics<br>|
| Active Comparator: ARM C<br>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 | Dietary Supplement: BetaQuik™<br>* MCT (Medium chain triglycerides)<br>Dietary Supplement: WheyBasics<br>* Whey Protein Isolate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diurnal glucose Incremental area under curve (iAUC) concentrations | Constant glucose monitoring (CGM) comparing treatment regimen A-B-C | 115 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose concentrations | Mean, standard deviation and coefficient of variation of 24h glucose concentration as 24h 24h assessed by CGM | 115 days | 
| Area under curve (AUC) glucose | 24h assessed by CGM | 115 days | 
| Incremental area under curve (iAUC) glucose | 24h assessed by CGM | 115 days | 
| Visual Analogue Scale (VAS) questionnaire | 100-point VAS on satiety | 115 days | 
| Glucose mean | Arterialised blood concentration | 115 days | 
| Glucose Incremental area under curve (iAUC) | Arterialised blood concentration | 115 days | 
| Leptin mean | Arterialised blood concentration | 115 days | 
| Leptin Incremental area under curve (iAUC) | Arterialised blood concentration | 115 days | 
| Gastric inhibitory polypeptide (GIP) - GLP-1 mean | Arterialised blood concentration | 115 days | 
| Glucagon-like peptide-1 (GLP-1) mean | Arterialised blood concentration | 115 days | 
| Gastric inhibitory polypeptide (GIP) - Incremental area under curve (iAUC) | Arterialised blood concentration | 115 days | 
| Glucagon-like peptide-1 (GLP-1) Incremental area under curve (iAUC) | Arterialised blood concentration | 115 days | 
| Peptide tyrosine tyrosine (PYY) mean | Arterialised blood concentration | 115 days | 
| Peptide tyrosine tyrosine (PYY) Incremental area under curve (iAUC) | Arterialised blood concentration | 115 days |