The Effects of Leucine on Body Weight

Obesity Clinical Trial

Official title:

Effects of Leucine Supplement on Body Weight and Cardiometabolic Changes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683826
• Other study ID #: AAAC6762
• Status: Completed
• Phase: N/A
• First received: May 22, 2008
• Last updated: March 4, 2013
• Start date: May 2007
• Est. completion date: February 2010

Study information

• Verified date: March 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects on Weight		4 weeks	No
Primary	Weight		at the end of each study treatment arm (six weeks)	No
Secondary	Energy Expenditure		will be measure at the end of each treatment period (6 weeks)	No