The Effects of Leucine on Body Weight

Columbia University

Status: Completed

Conditions: Overweight; Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00683826

AAAC6762

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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8 participants in 3 patient groups, including a placebo group

L-Leucine 4grams

Experimental group

Description:

This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.

Treatment:

Other: Liquid meal

Dietary Supplement: L-Leucine 4g

L-Leucine 8 grams

Experimental group

Description:

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

Treatment:

Other: Liquid meal

Dietary Supplement: L-Leucine 8gr

L-Leucine 0 grams

Placebo Comparator group

Description:

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

Treatment:

Other: Liquid meal