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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034241
First Posted: December 17, 2009
Last Update Posted: July 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nederlandse Zuivel Organisatie
Information provided by:
Maastricht University Medical Center
  Purpose
The purpose of this study is to determine whether different protein diets affects glucose and insulin metabolism and substrate partitioning.

Condition Intervention
Insulin Glucose Metabolism Dietary Supplement: Control Dietary Supplement: High dairy protein Dietary Supplement: vegetable protein Dietary Supplement: High GI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Different Protein Diets on Glucose and Insulin Metabolism and Substrate Partitioning

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Glucose and insulin metabolism (24 h) [ Time Frame: 24 h ]

Secondary Outcome Measures:
  • Substrate partitioning and metabolic markers [ Time Frame: 24 h ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034241


Sponsors and Collaborators
Maastricht University Medical Center
Nederlandse Zuivel Organisatie
Investigators
Principal Investigator: Wim Saris, Prof. Dr. Maastricht University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. dr. WHM Saris, University of Maastricht
ClinicalTrials.gov Identifier: NCT01034241     History of Changes
Other Study ID Numbers: MEC 08-3-072
First Submitted: December 16, 2009
First Posted: December 17, 2009
Last Update Posted: July 23, 2010
Last Verified: July 2010

Keywords provided by Maastricht University Medical Center:
milk protein
overweight
insulin metabolism
substrate partitioning

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs