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:
- 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.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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.
|
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.
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.
|
|
Placebo Comparator: L-Leucine 0 grams
The third arm of the study will be composed of a control drink with no leucine in it.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Effects on Weight
Time Frame: 4 weeks
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4 weeks
|
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Weight
Time Frame: at the end of each study treatment arm (six weeks)
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at the end of each study treatment arm (six weeks)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Energy Expenditure
Time Frame: will be measure at the end of each treatment period (6 weeks)
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will be measure at the end of each treatment period (6 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Henry Ginsberg, MD, Columbia University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAC6762
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