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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: WHE; Dietary supplement: speWHE

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: WHE (regular whey protein); 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.	Dietary supplement: WHE; 25 gram protein of a regular whey compound
Experimental: speWHE (specific whey protein compound); 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.	Dietary supplement: speWHE; 25 gram of a specific whey fraction (confidential)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in iAUC for insulin between WHE and speWHE	Difference in iAUC for insulin between WHE and speWHE	OGTT, 3 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in iAUC and concentration differences for GIP		OGTT 3 hours
Differences in iAUC and concentration differences for GLP-1		OGTT 3 hours
Differences in iAUC and concentration differences for glucagon		OGTT 3 hours
Differences in iAUC and concentration differences for glucose		OGTT 3 hours
Differences in iAUC and concentration differences for C-peptid		OGTT 3 hours
Differences in iAUC and concentration differences for FFA		OGTT 3 hours
Activity measurements		5 days
continuous glucose measurement (CGM)	CGM with time in normal range 4-10 mmol/l, peak after a meal, AUC in the days with the interventions.	5 days

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Director: Niels Jessen, Professor, Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): June 17, 2020
• Study Completion (Actual): June 24, 2020

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: TAKE4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No