Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.

University of Aarhus

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: speWHE; Dietary Supplement: WHE

Study type: Interventional

Funder types: Other

Identifiers

NCT04166760

TAKE4

Details and patient eligibility

About

The main objective of our study is to investigate the metabolic effects of a i) ordinary whey protein (WHE) and ii) a specific whey protein fraction (speWHE) when the interventions are ingested by patients with type 2 diabetes 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate the glucose response when the patients ingest the interventions at home in their own environment 30 minutes before breakfast and dinner (2days) and also monitor glucose levels without interventions (2 days).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Type 2 diabetes (T2D) diagnosis
• No medical treatment or metformin/sulfonylureas(SU) alone in the treatment of T2D
• No daily use of protein drinks
• Hba1c between 40 mmol/mol and 69 mmol/mol
• 20 kg/m2 < BMI < 35 kg/m2
• Screening blood test: 1200 pmol/l > C-peptid > 370 pmol/l

Exclusion criteria

• Other diabetes medication than metformin/SU (e.g. insulin, GLP-1 analog, DPP-4 inhibitor, SGLT2-inhibitor)
• Affected screening blood test assessed by the primary investigator(PI)/sponsor
• Does not understand or speak danish
• Milk allergy
• PI finds the patient not fit (e.g. mental illness, too nervous or other)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

WHE (regular whey protein)

Active Comparator group

Description:

Regular whey protein. The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast and dinner for 2 days in the patient's own environment.

Treatment:

Dietary Supplement: WHE

speWHE (specific whey protein compound)

Experimental group

Description:

Specific whey protein compound. The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast and dinner for 2 days in the patient's own environment.

Treatment:

Dietary Supplement: speWHE