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

May 22, 2008
March 4, 2013
May 2007
February 2010   (final data collection date for primary outcome measure)
  • Effects on Weight [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at the end of each study treatment arm (six weeks) ] [ Designated as safety issue: No ]
Weight [ Time Frame: at the end of each study treatment arm (six weeks) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00683826 on ClinicalTrials.gov Archive Site
Energy Expenditure [ Time Frame: will be measure at the end of each treatment period (6 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Leucine on Body Weight
Effects of Leucine Supplement on Body Weight and Cardiometabolic Changes

Protein-rich diets appear to show some benefits in promoting weight loss. It is thought that increased intake of leucine may account for some of this effect. This study is designed to assess whether any of the beneficial effects of dietary leucine supplementation observed in mice also apply to humans.

Specifically, our team would like to determine whether oral leucine supplementation in overweight/obese humans increases metabolic rate, reduces body weight, improves glucose utilization and/or, reduces circulating fat levels in the blood. We hope that the results obtained from this pilot study will highlight the specific aspects of metabolic improvement associated with increased daily leucine intake. This study will should provide data that can be used to design more definitive trials with regard to dietary leucine supplementation.

Hypothesis

This pilot study is designed to accomplish the following two goals:

  1. to assess whether any of the beneficial effects of dietary leucine supplementation observed in mice also apply in humans. Specifically, we want to determine whether oral leucine supplementation in overweight/obese individuals' increases basal metabolic rate, reduces body weight, improves glucose tolerance and/or insulin sensitivity, and/or reduces circulating Low-density Lipoprotein (LDL)-cholesterol levels.
  2. To provide data that can be used to design more definitive trials with regard to dietary leucine supplementation.

We hope that the results obtained from this pilot study will highlight the specific aspects of metabolic improvement associated with increased daily leucine intake. This would in turn lead to more rigorous clinical trials involving larger sample sizes, and with diverse populations of different gender, age, and ethnic groups. Future trials may also be directed to determine minimal doses and durations of leucine supplementation that are capable of achieving clinically significant improvement in the cardio-metabolic risk profile in people.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Overweight
  • Obesity
  • Dietary Supplement: L-Leucine 8gr
    Supplementation in the form of a liquid meal (premixed leucine powder solutions with flavor made by the Bionutrition Unit of the Irving Insitute for Clinical and Translational Research (IICTR)). Dosing of leucine will be a combination of 2 ounces of liquid per 1 gm of leucine. L-leucine was purchased (FCC quality) from Spectrum Chemical,California. Certificate of analysis enclosed (99.89% leucine).Liquid meal preparation: Grape juice and crystal light mixes will be used for the preparation of liquid meals that will be given to each participant each week. Participants will consume two 8 ounce drinks (packaged in two 10 ounce bottles) per day. Each drink will be individually prepared with 8 grams of leucine.
  • Other: Liquid meal
    Liquid meal preparation (contents): Grape juice and crystal light mixes will be used for the preparation of liquid meals that will be given to each participant each week. Participants will consume two 8 ounce drinks (packaged in two 10 ounce bottles) per day. The placebo group will have the same drinks listed above with no leucine incorporated.
  • Dietary Supplement: L-Leucine 4g
    Supplementation in the form of a liquid meal (premixed leucine powder solutions with flavor made by the Bionutrition Unit of the Irving Insitute for Clinical and Translational Research (IICTR)). Dosing of leucine will be a combination of 2 ounces of liquid per 1 gm of leucine. L-leucine was purchased (FCC quality) from Spectrum Chemical,California. Certificate of analysis enclosed (99.89% leucine).Liquid meal preparation: Grape juice and crystal light mixes will be used for the preparation of liquid meals that will be given to each participant each week. Participants will consume two 8 ounce drinks (packaged in two 10 ounce bottles) per day. Each drink will be individually prepared with 4 grams of leucine.
  • Experimental: L-Leucine 4grams
    This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
    Interventions:
    • Other: Liquid meal
    • Dietary Supplement: L-Leucine 4g
  • Experimental: L-Leucine 8 grams
    Arm number two of the study will be a dose of Leucine of 8g.
    Interventions:
    • Dietary Supplement: L-Leucine 8gr
    • Other: Liquid meal
  • Placebo Comparator: L-Leucine 0 grams
    The third arm of the study will be composed of a control drink with no leucine in it.
    Intervention: Other: Liquid meal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-65 year old overweight/obese
  • healthy men and women
  • Body Mass Index (BMI) of 28-35

Exclusion Criteria:

  • unusual or extreme dietary or exercise habits
  • daily leucine supplement use
  • inability to follow instructions to drink liquid meals
  • type 1 diabetes or type 2 diabetes on drug treatment(diet controlled diabetics will be enrolled after consulting with their treating physicians)
  • hypothyroidism or hyperthyroidism
  • chronic wasting diseases (Acquired Immune Deficiency Syndrome (AIDS), cancers, cirrhosis, renal failure, Chronic Obstructive Pulmonary Disease (COPD), heart failure)
  • drug or alcohol abuse
  • tobacco smoker within the past 6 months
  • pregnancy or lactating
  • use of medications known to affect carbohydrate or lipid metabolism, satiety, or hunger
  • anemia
  • abnormal liver function tests (LFTs)
  • women who are of child bearing age without adequate birth control modality
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00683826
AAAC6762
Yes
Henry N. Ginsberg, Columbia University
Columbia University
Not Provided
Principal Investigator: Henry Ginsberg, MD Columbia University
Columbia University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP