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

NCT04905589 | Completed

• 1 other identifier: 19.18.CLI
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Diurnal glucose Incremental area under curve (iAUC) concentrations

  Constant glucose monitoring (CGM) comparing treatment regimen A-B-C

  115 days

Secondary Outcomes (14)

• Glucose concentrations

  115 days

• Area under curve (AUC) glucose

  115 days

• Incremental area under curve (iAUC) glucose

  115 days

• Visual Analogue Scale (VAS) questionnaire

  115 days

• Glucose mean

  115 days

Study Arms (3)

ARM A

PLACEBO COMPARATOR

Subsequent order of intake : Iso-voluminous water, breakfast, iso-voluminous water, lunch, iso-voluminous water, dinner

Other: Iso-voluminous water

ARM B

ACTIVE COMPARATOR

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

Dietary Supplement: BetaQuik™; Other: Iso-voluminous water

ARM C

ACTIVE COMPARATOR

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™; Dietary Supplement: WheyBasics

Interventions

BetaQuik™ DIETARY_SUPPLEMENT

MCT (Medium chain triglycerides)

ARM B; ARM C

WheyBasics DIETARY_SUPPLEMENT

Whey Protein Isolate

ARM C

Iso-voluminous water OTHER

Iso-voluminous Water as comparitor to Betaquik or WheyBasics

ARM A; ARM B

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

Location

Related Publications (1)

• Pabla P, Mallinson J, Nixon A, Keeton M, Cooper S, Marshall M, Jacques M, Brown S, Johansen OE, Cuenoud B, Karagounis LG, Tsintzas K. Effect of medium-chain triglycerides and whey protein isolate preloads on glycaemia in type 2 diabetes: a randomized crossover study. Am J Clin Nutr. 2025 Feb;121(2):232-245. doi: 10.1016/j.ajcnut.2024.12.022. Epub 2024 Dec 26.

  PMID: 39732398 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Professor Kostas Tsintzas

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 27, 2021
• Study Start: April 30, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)