The Effects of Leucine on Body Weight

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Henry N. Ginsberg, Columbia University

ClinicalTrials.gov Identifier:

NCT00683826

First received: May 22, 2008

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Results First Received: March 1, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Overweight Obesity
Interventions:	Dietary Supplement: L-Leucine 8gr Other: Liquid meal Dietary Supplement: L-Leucine 4g

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was completed. All subjects were recruited from the surrounding neighborhood and affiliates of Columbia University Medical Center (CUMC).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
All Study Participants	This will be a three-way crossover design, where subjects will be randomized into three groups. All subjects will receive all interventions (0g leucine, 4g leucine, 8g leucine) in a randomized order.

Participant Flow: Overall Study

	All Study Participants
STARTED	8
0g Leucine	8
8g Leucine	8
4g Leucine	7
COMPLETED	7
NOT COMPLETED	1

Baseline Characteristics

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Reporting Groups

	Description
Leucine 4 Grams	Initial intervention.
Leucine 8 Grams	Initial intervention.
Leucine 0 Grams-control	Initial intervention.
Total	Total of all reporting groups

Baseline Measures

	Leucine 4 Grams	Leucine 8 Grams	Leucine 0 Grams-control	Total
Number of Participants [units: participants]	2	3	3	8
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	2	3	3	8
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	35 ± 7	40 ± 7	45 ± 7	40 ± 7
Gender [units: participants]
Female	1	3	3	7
Male	1	0	0	1
Region of Enrollment [units: participants]
United States	2	3	3	8

Outcome Measures

1. Primary:

Effects on Weight [ Time Frame: 4 weeks ]

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2. Primary:

Weight [ Time Frame: at the end of each study treatment arm (six weeks) ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Energy Expenditure [ Time Frame: will be measure at the end of each treatment period (6 weeks) ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Henry N. Ginsberg MD, Gissette Reyes Soffer MD
Organization: Columbia University Medical Center
phone: 2123059298
e-mail: gr2104@columbia.edu

No publications provided

Responsible Party:	Henry N. Ginsberg, Columbia University
ClinicalTrials.gov Identifier:	NCT00683826 History of Changes
Other Study ID Numbers:	AAAC6762
Study First Received:	May 22, 2008
Results First Received:	March 1, 2011
Last Updated:	March 4, 2013
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

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