OverweightNCT00683826
The Effects of Leucine on Body Weight
A study testing L-Leucine 8gr, Liquid meal and L-Leucine 4g in people with Overweight and Obesity, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- L-Leucine 8gr, Liquid meal and L-Leucine 4g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 year old overweight/obese
- healthy men and women
- Body Mass Index (BMI) of 28-35
Who cannot join
- 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)
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: 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.
Read more
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.
- Conditions
- Overweight, Obesity
- Being tested
- L-Leucine 8gr, Liquid meal, L-Leucine 4g
- Keywords
- Leucine, Weight Loss
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Leucine 8grDietary supplement
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 mealOther
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.
L-Leucine 4gDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| L-Leucine 4grams | Experimental | This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine. Receives: Other: Liquid meal; Dietary Supplement: L-Leucine 4g |
| L-Leucine 8 grams | Experimental | Arm number two of the study will be a dose of Leucine of 8g. Receives: Dietary Supplement: L-Leucine 8gr; Other: Liquid meal |
| L-Leucine 0 grams | Placebo comparator | The third arm of the study will be composed of a control drink with no leucine in it. Receives: Other: Liquid meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on Weight
Measured: 4 weeks
Weight
Measured: at the end of each study treatment arm (six weeks)
Secondary outcomes (1)
Energy Expenditure
Measured: will be measure at the end of each treatment period (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startMay 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry N. Ginsberg, Columbia University
- Investigators
- Henry Ginsberg, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683826
- Sponsor's protocol ID
- AAAC6762
- Status last verified
- Mar 2013
- First submitted
- 22 May 2008
- Last updated
- 5 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Leucine Supplement on Body Weight and Cardiometabolic Changes
- ClinicalTrials.gov ID
- NCT00683826
- Acronym / sponsor ID
- AAAC6762
- Conditions
- Overweight, Obesity
- Keywords
- Leucine, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 9 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L-Leucine 4grams | Experimental | Other: Liquid meal, Dietary Supplement: L-Leucine 4gThis 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 | Experimental | Dietary Supplement: L-Leucine 8gr, Other: Liquid mealArm number two of the study will be a dose of Leucine of 8g. |
| L-Leucine 0 grams | Placebo comparator | Other: Liquid mealThe third arm of the study will be composed of a control drink with no leucine in it. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 year old overweight/obese
- healthy men and women
- Body Mass Index (BMI) of 28-35
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-Leucine 8grSupplementation 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. | Dietary supplement | L-Leucine 8 grams |
| Liquid mealLiquid 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. | Other | L-Leucine 0 grams, L-Leucine 4grams, L-Leucine 8 grams |
| L-Leucine 4gSupplementation 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. | Dietary supplement | L-Leucine 4grams |
Primary outcome
Effects on Weight
Time frame: 4 weeks
Weight
Time frame: at the end of each study treatment arm (six weeks)
1 secondary outcome
Energy Expenditure
Time frame: will be measure at the end of each treatment period (6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Ginsberg, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Leucine 8gr, Liquid meal and L-Leucine 4g in people with Overweight and Obesity, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on Weight (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013.