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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905589
• Other study ID #: 19.18.CLI
• Status: Completed
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• BetaQuik™
MCT (Medium chain triglycerides)
• WheyBasics
Whey Protein Isolate

Other:
• Iso-voluminous water
Iso-voluminous Water as comparitor to Betaquik or WheyBasics

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diurnal glucose Incremental area under curve (iAUC) concentrations	Constant glucose monitoring (CGM) comparing treatment regimen A-B-C	115 days
Secondary	Glucose concentrations	Mean, standard deviation and coefficient of variation of 24h glucose concentration as 24h 24h assessed by CGM	115 days
Secondary	Area under curve (AUC) glucose	24h assessed by CGM	115 days
Secondary	Incremental area under curve (iAUC) glucose	24h assessed by CGM	115 days
Secondary	Visual Analogue Scale (VAS) questionnaire	100-point VAS on satiety	115 days
Secondary	Glucose mean	Arterialised blood concentration	115 days
Secondary	Glucose Incremental area under curve (iAUC)	Arterialised blood concentration	115 days
Secondary	Leptin mean	Arterialised blood concentration	115 days
Secondary	Leptin Incremental area under curve (iAUC)	Arterialised blood concentration	115 days
Secondary	Gastric inhibitory polypeptide (GIP) - GLP-1 mean	Arterialised blood concentration	115 days
Secondary	Glucagon-like peptide-1 (GLP-1) mean	Arterialised blood concentration	115 days
Secondary	Gastric inhibitory polypeptide (GIP) - Incremental area under curve (iAUC)	Arterialised blood concentration	115 days
Secondary	Glucagon-like peptide-1 (GLP-1) Incremental area under curve (iAUC)	Arterialised blood concentration	115 days
Secondary	Peptide tyrosine tyrosine (PYY) mean	Arterialised blood concentration	115 days
Secondary	Peptide tyrosine tyrosine (PYY) Incremental area under curve (iAUC)	Arterialised blood concentration	115 days