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

NCT ID: NCT04166760

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2020-06-24

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double blinded, randomized, crossover design
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

WHE

Intervention Type DIETARY_SUPPLEMENT

25 gram protein of a regular whey compound

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.

Group Type EXPERIMENTAL

speWHE

Intervention Type DIETARY_SUPPLEMENT

25 gram of a specific whey fraction (confidential)

Interventions

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speWHE

25 gram of a specific whey fraction (confidential)

Intervention Type DIETARY_SUPPLEMENT

WHE

25 gram protein of a regular whey compound

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niels Jessen, Professor

Role: STUDY_DIRECTOR

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

Locations

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

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TAKE4

Identifier Type: -

Identifier Source: org_study_id