The Effect of Leucine on Body Composition and Muscle Char... | NCT00643773

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

NCT00643773

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Aug 26, 2011Estimated

Enrollment

60Estimated

Phase

Phase 2Phase 3

Conditions

Type 2 Diabetes

Interventions

Leucine
Wheat flour

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Jun 2010Actual

First Submitted Date

Mar 20, 2008

First Submission Date that Met QC Criteria

Mar 25, 2008

First Posted Date

Mar 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2011

Last Update Posted Date

Aug 26, 2011Estimated

Name	Class
Top Institute Food and Nutrition	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Leucine supplement	Dietary Supplement: Leucine
B	Placebo Comparator	Wheat flour	Dietary Supplement: Wheat flour

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	A

Measure	Description	Time Frame
Body Composition		1, 3, and 6 months

Measure	Description	Time Frame
Muscle characteristics		1, 3, and 6 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marika Leenders, MSc	Maastricht University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University		Maastricht		6229 ER	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21525248	Derived	Leenders M, Verdijk LB, van der Hoeven L, van Kranenburg J, Hartgens F, Wodzig WK, Saris WH, van Loon LJ. Prolonged leucine supplementation does not augment muscle mass or affect glycemic control in elderly type 2 diabetic men. J Nutr. 2011 Jun;141(6):1070-6. doi: 10.3945/jn.111.138495. Epub 2011 Apr 27.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D007930	Leucine
D005433	Flour

ID	Term
D000597	Amino Acids, Branched-Chain
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000601	Amino Acids, Essential