The influence of whey protein on free-living glycaemic control in type 2 diabetes

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN17563146
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35618446/ (added 27/05/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35276924/ Qualitative interview study (added 14/06/2023) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39138690/ Secondary analysis (added 15/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-21
• Study Completion: 2021-09-01
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Diagnosed with type 2 diabetes mellitus for at least 1 year prior to participation in this trial.
2. Treated with either lifestyle modifications and/or oral medications, which have been stable for 3 months or more.
3. Weight stable for 1 month or more (i.e. weight has not fluctuated by more than 1kg prior to study enrolment).
4. HbA1c of below 9.5% (80mmol/mol)
5. Aged between 30-68 years of age
6. Regularly consume breakfast
7. Adhere to a normal sleep/wake cycle

Exclusion Criteria

1. Treated with insulin or incretin mimetic therapies.
2. History of severe cardiovascular events, renal failure or liver disease within the last 12 months.
3. Gastrointestinal issues.
4. Known food intolerance's or allergies.
5. Substance abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postprandial glycaemic responses (incremental area under the curve) to patient’s free-living main meals (breakfast, lunch and dinner) following prior consumption of the protein-rich and protein-depleted supplement (i.e. pre-load”). Glycaemic responses will be measured from interstitial glucose concentrations collected from patient's continuous glucose monitoring system (CGM) over a 7-day free-living period, where a postprandial period will be defined as an uninterrupted 2-hour phase following commencement of a reported meal. Postprandial glycaemic responses will be calculated using the trapezoidal rule.