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
  Purpose

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.


Condition Intervention
Overweight
Obesity
Dietary Supplement: L-Leucine 8gr
Other: Liquid meal
Dietary Supplement: L-Leucine 4g

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
Official Title: Effects of Leucine Supplement on Body Weight and Cardiometabolic Changes

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Energy Expenditure [ Time Frame: will be measure at the end of each treatment period (6 weeks) ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: May 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 8 grams
Arm number two of the study will be a dose of Leucine of 8g.
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.
Placebo Comparator: L-Leucine 0 grams
The third arm of the study will be composed of a control drink with no leucine in it.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683826

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Henry Ginsberg, MD Columbia University
  More Information

No publications provided

Responsible Party: Henry N. Ginsberg, Herbert and Florence Irving Professor of Medicine; Director - Irving Institute for Clinical & Translational Research, 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

Keywords provided by Columbia University:
Leucine
Weight Loss

Additional relevant MeSH terms:
Body Weight
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014