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NCT Number: NCT00683826

The Effects of Leucine on Body Weight

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.

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Key information

Conditions

Overweight Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-Leucine 8gr

Dietary Supplement

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.

liquid meal

Other

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.

L-Leucine 4g

Dietary Supplement

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.

Primary outcomes

  1. Effects on Weight

    Time frame: 4 weeks

  2. Weight

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

Secondary outcomes

  1. Energy Expenditure

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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Effects of Leucine Supplement on Body Weight and Cardiometabolic Changes

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 26, 2008
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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