Effect of Different Protein Diets on Glucose and Insulin Metabolism and Substrate Partitioning

August 21, 2018 updated by: Maastricht University Medical Center
The purpose of this study is to determine whether different protein diets affects glucose and insulin metabolism and substrate partitioning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI: 18.5-25 kg/m2 (lean)
  • Gender: Male
  • Age: <35 years
  • Caucasian

Exclusion Criteria:

  • Elevated fasting blood glucose level
  • Lactose intolerant
  • Diabetes Mellitus
  • Hypertension (systolic/diastolic blood pressure)
  • Hypotension (systolic/diastolic blood pressure)
  • Cardiovascular diseases
  • Asthma and other obstructive pulmonary diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
Diet consists of 15% dairy protein and low Glycemic Index (GI < 40), 55 En% carbohydrates and 30 En% fat
Dietary supplement: Control
Diet consists of 15 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat
Experimental: High dairy protein
Diet consists of 25% dairy protein and low GI (GI < 40), 45 En% carbohydrates and 30 En% fat
Dietary supplement: High dairy protein
Diet consists of 25 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat
Experimental: vegetable protein
Diet consists of 15 En% vegetable protein and low GI (GI < 40), 55 En% carbohydrates and 30 En% fat
Dietary supplement: vegetable protein
Diet consists of 15 En% vegetable protein and low GI, 55 En% carbohydrates and 30 En% fat
Experimental: High GI
Diet consists of 15 En% dairy protein and high GI(GI > 60, 55 En% carbohydrates and 30 En% fat
Dietary supplement: High GI
Diet consists of 15 En% dairy protein and high GI, 55 En% carbohydrates and 30 En% fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose and insulin metabolism (24 h)
Time Frame: 24 h
24 h

Secondary Outcome Measures

Outcome Measure
Time Frame
Substrate partitioning and metabolic markers
Time Frame: 24 h
24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Nederlandse Zuivel Organisatie

Investigators

  • Principal Investigator: Wim Saris, Prof. Dr., Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (Estimate)

December 17, 2009

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MEC 08-3-072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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