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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Iso-voluminous water; Dietary supplement: BetaQuik™; Dietary supplement: WheyBasics

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Professor Kostas Tsintzas, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 19.18.CLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No