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OpenTrials
Completed

NCT Number: NCT00643773

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Maastricht University

Maastricht, 6229 ER, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leucine

Dietary Supplement

capsules are 0.5g, subjects take 5 capsules with every main meal for 6 months In total this is 15 capsules per day

Wheat flour

Dietary Supplement

Wheat flour

Primary outcomes

  1. Body Composition

    Time frame: 1, 3, and 6 months

Secondary outcomes

  1. Muscle characteristics

    Time frame: 1, 3, and 6 months

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 26, 2008
Registry last updated
Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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