The Effects of Leucine on Body Weight

NCT00683826 | Completed Results DMC

• 1 other identifier: AAAC6762
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To provide data that can be used to design more definitive trials with regard to dietary leucine supplementation.

Conditions

Overweight; Obesity

Keywords

Leucine; Weight Loss

Outcome Measures

Primary Outcomes (2)

• Effects on Weight

  4 weeks

• Weight

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

Secondary Outcomes (1)

• Energy Expenditure

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

Study Arms (3)

L-Leucine 4grams

EXPERIMENTAL

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; Dietary Supplement: L-Leucine 4g

L-Leucine 8 grams

EXPERIMENTAL

Arm number two of the study will be a dose of Leucine of 8g.

Dietary Supplement: L-Leucine 8gr; Other: Liquid meal

L-Leucine 0 grams

PLACEBO COMPARATOR

The third arm of the study will be composed of a control drink with no leucine in it.

Other: Liquid meal

Interventions

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.

L-Leucine 8 grams

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 0 grams; L-Leucine 4grams; L-Leucine 8 grams

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.

L-Leucine 4grams

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Interventions

Leucine

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Results Point of Contact

• Title: Henry N. Ginsberg MD, Gissette Reyes Soffer MD
• Organization: Columbia University Medical Center

gr2104@columbia.edu

2123059298

Study Officials

• Henry Ginsberg, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Herbert and Florence Irving Professor of Medicine; Director - Irving Institute for Clinical & Translational Research

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: May 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 5, 2013
• Results First Posted: August 9, 2011

Record last verified: 2013-03

Locations

US (1)