Protein Hydrolyzation and Glycemic Control

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. Identifier: NCT01034618
Recruitment Status : Completed
First Posted : December 17, 2009
Last Update Posted : December 17, 2009
Information provided by:
Maastricht University Medical Center

Brief Summary:
The insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic controls. The objective of the study is to investigate the optimal dose of such an insulinotropic mixture.

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Protein hydrolyzation Not Applicable

Study Type : Interventional  (Clinical Trial)
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Additional Effects of Protein Hydrolysate Supplementation on Glucose Homeostasis in Type 2 Diabetes
Study Start Date : December 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Protein hydrolyzation
Experimental: Intact protein Dietary Supplement: Protein hydrolyzation
Experimental: Protein hydrolysate Dietary Supplement: Protein hydrolyzation

Primary Outcome Measures :
  1. Glucose and insulin homeostasis.

Secondary Outcome Measures :
  1. Plasma amino acid profiles

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male
  • Age between 40 and 70 years
  • Oral blood glucose lowering medication
  • BMI < 35 kg/m2

Exclusion Criteria:

  • Exogenous insulin use
  • Cardiac disease (any cardiac event in the last 5 years)
  • Diabetic complications (microvascular complications, microalbuminuria: albumin:creatinine ratio >2,5)

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 identifier (NCT number): NCT01034618

Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6229ER
Sponsors and Collaborators
Maastricht University Medical Center

Responsible Party: Ralph J.F. Manders, PhD, Maastricht University Medical Center Identifier: NCT01034618     History of Changes
Other Study ID Numbers: 06-3-081
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: December 17, 2009
Last Verified: December 2009

Keywords provided by Maastricht University Medical Center:
protein hydrolysate