The Effect of Leucine on Body Composition and Muscle Characteristics in Elderly, Type 2 Diabetes Patients

This study is currently recruiting participants.

Verified by Maastricht University Medical Center, February 2009

First Received: March 20, 2008 Last Updated: February 3, 2009 History of Changes

Sponsors and Collaborators:	Maastricht University Medical Center Top Institute Food and Nutrition
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00643773

Purpose

The purpose of this study is to determine whether long term leucine supplementation has a positive effect on body composition and muscle characteristics in elderly, type 2 diabetes patients.

Condition	Intervention	Phase
Type 2 Diabetes	Dietary Supplement: Leucine Dietary Supplement: Wheat flour	Phase II Phase III

MedlinePlus related topics: Diabetes Dietary Supplements Diets

Drug Information available for: Leucine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver), Factorial Assignment, Efficacy Study
Official Title:	The Influence of Leucine Supplementation on Body Composition and Muscle Characteristics in Elderly, Type 2 Diabetes Patients.

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

Body Composition [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Muscle characteristics [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2008
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Leucine supplement	Dietary Supplement: Leucine capsules are 0.5g, subjects take 5 capsules with every main meal for 6 months In total this is 15 capsules per day
B: Placebo Comparator Wheat flour	Dietary Supplement: Wheat flour Wheat flour

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of type 2 diabetes

Exclusion Criteria:

Impaired renal or liver function
Cardiac disease
Subjects with metal implants
Hypertension
Diabetes complications
Exogenous insulin therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643773

Contacts

Contact: Marika Leenders, MSc	043 3881394 ext +31	Marika.Leenders@BW.unimaas.nl
Contact: Luc JC van Loon, PhD	043 3881397 ext +31	L.vanLoon@hb.unimaas.nl

Locations

Netherlands
Maastricht University	Recruiting
Maastricht, Netherlands, 6229 ER
Contact: Marika Leenders, MSc +31433881394 Marika.Leenders@BW.unimaas.nl
Principal Investigator: Marika Leenders, MSc

Sponsors and Collaborators

Maastricht University Medical Center

Top Institute Food and Nutrition

Investigators

Principal Investigator:

Marika Leenders, MSc

Maastricht University Medical Center

More Information

No publications provided

Responsible Party:	Maastricht University ( MSc Marika Leenders )
Study ID Numbers:	MEC-07-1111
Study First Received:	March 20, 2008
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00643773 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:

Elderly

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009