Trial Outcomes & Findings for The Effects of Leucine on Body Weight (NCT NCT00683826)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

4 weeks

Results posted on

2013-03-05

Participant Flow

Recruitment was completed. All subjects were recruited from the surrounding neighborhood and affiliates of Columbia University Medical Center (CUMC).

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	8
Overall Study 0g Leucine	8
Overall Study 8g Leucine	8
Overall Study 4g Leucine	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Leucine on Body Weight

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Leucine 4 Grams n=2 Participants Initial intervention.	Leucine 8 Grams n=3 Participants Initial intervention.	Leucine 0 Grams-control n=3 Participants Initial intervention.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	35 years STANDARD_DEVIATION 7 • n=5 Participants	40 years STANDARD_DEVIATION 7 • n=7 Participants	45 years STANDARD_DEVIATION 7 • n=5 Participants	40 years STANDARD_DEVIATION 7 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	8 participants n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Leucine 4 Grams n=7 Participants This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.	Leucine 8 Grams n=8 Participants Arm number two of the study will be a dose of Leucine of 8g.	Leucine 0 Grams-control n=8 Participants The third arm of the study will be composed of a control drink with no leucine in it.
Effects on Weight	93.4 kilograms Standard Deviation 16.8	91.7 kilograms Standard Deviation 17.2	91.9 kilograms Standard Deviation 15.2

PRIMARY outcome

Timeframe: at the end of each study treatment arm (six weeks)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: will be measure at the end of each treatment period (6 weeks)

Outcome measures

Outcome data not reported

Adverse Events

Leucine 4 Grams

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Leucine 8 Grams

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Leucine 0 Grams-control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Henry N. Ginsberg MD, Gissette Reyes Soffer MD

Columbia University Medical Center

Phone: 2123059298

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place