The Effects of Leucine on Body Weight
Condition: Overweight; Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional

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.
    


Intervention name(s): L-Leucine 8gr; Liquid meal; L-Leucine 4g
Intervention type(s): Dietary Supplement; Other; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Leucine; Weight Loss