Clinical trial NCT00683826: The Effects of Leucine on Body Weight
Official title: Effects of Leucine Supplement on Body Weight and Cardiometabolic Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Leucine
Weight Loss
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2008-05-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effects on Weight
timeFrame: 4 weeks
measure: Weight
timeFrame: at the end of each study treatment arm (six weeks)
Secondary outcomes:
measure: Energy Expenditure
timeFrame: will be measure at the end of each treatment period (6 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Henry Ginsberg, MD
role: PRINCIPAL_INVESTIGATOR
References: