The Effects of Leucine on Body Weight

Not Applicable

Completed

Conditions: Overweight
Obesity

Interventions: Other: Liquid meal
Dietary Supplement: L-Leucine 8gr
Dietary Supplement: L-Leucine 4g

Registration Number: NCT00683826

Lead Sponsor: Columbia University

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. 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
L-Leucine 4grams	Liquid meal	This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
L-Leucine 4grams	L-Leucine 4g	This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
L-Leucine 8 grams	L-Leucine 8gr	Arm number two of the study will be a dose of Leucine of 8g.
L-Leucine 8 grams	Liquid meal	Arm number two of the study will be a dose of Leucine of 8g.
L-Leucine 0 grams	Liquid meal	The third arm of the study will be composed of a control drink with no leucine in it.