ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01034241
Recruitment Status : Completed
First Posted : December 17, 2009
Last Update Posted : July 23, 2010
Sponsor:
Collaborator:
Nederlandse Zuivel Organisatie
Information provided by:
Maastricht University Medical Center

Brief Summary:
The purpose of this study is to determine whether different protein diets affects glucose and insulin metabolism and substrate partitioning.

Condition or disease Intervention/treatment Phase
Insulin Glucose Metabolism Dietary Supplement: Control Dietary Supplement: High dairy protein Dietary Supplement: vegetable protein Dietary Supplement: High GI Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Study Start Date : April 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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 Posted: December 17, 2009    Key Record Dates
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