Protein Hydrolyzation and Glycemic Control

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01034618
• Collaborator: (none)
• Location: 1
• Arms: 3
• Duration (Months): 16

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Dec 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Glucose and insulin homeostasis. []

Secondary Outcome Measures

1. Plasma amino acid profiles []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center+	Maastricht	Limburg	Netherlands	6229ER

Sponsors and Collaborators

• Maastricht University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01034618
• Other Study ID Numbers: 06-3-081
• First Posted: Dec 17, 2009
• Last Update Posted: Dec 17, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: Diabetes; protein; protein hydrolysate
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Dec 17, 2009