Clinical trial NCT01710722: The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man
Official title: The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2012-10-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare three treatments to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.

Detailed description: Three treatments are compared to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.

1) Leptin A-200 injections daily with 2 inactive pills taken three times a day, 2) Caffeine with ephedrine pills taken 3 times a day with an inactive injection daily and 3) Both Leptin A-200 injections daily and caffeine with ephedrine pills taken three times a day.

Eligibility criteria: Inclusion Criteria:

* You are healthy.
* You are not pregnant or nursing.
* You are between 18 and 60 years of age.
* You have a body mass index, calculated from your height and weight, of 30 to 40 kg/m2.

Exclusion Criteria:

* You take chronic medications except hormone replacement or contraception.
* You are a woman and are unwilling to use effective contraception during the trial.
* You have blood pressure higher than 150/90.
* You have heart disease.
* You have urinary symptoms from an enlarged prostate.
* You have gained or lost more than 10 pounds in the last 6 months.
* You have used a monoamine oxidase inhibitor medication in the last month.
* You have high or low thyroid function that has not been controlled in the normal range for at least 2 months.
* You have heart disease or a history of stroke.
* You have a known sensitivity to E. coli or E. coli derived products.

Primary outcomes:
measure: Compare the percent loss of total body fat to the percent loss of visceral fat with leptin alone, caffeine and ephedrine and the combination of leptin,caffeine and ephedrine.
timeFrame: 28 weeks
Secondary outcomes:
measure: Compare the loss of fat and lean tissue with leptin alone.
timeFrame: 28 Weeks
measure: To compare the loss of fat and lean tissue with caffeine with ephedrine alone.
timeFrame: 28 Weeks
measure: compare the loss of fat and lean tissue with leptin, ephedrine and caffeine combination.
timeFrame: 28 Weeks
measure: To compare weight loss with leptin alone.
timeFrame: 28 Weeks
measure: To compare weight loss caffeine with ephedrine alone.
timeFrame: 28 Weeks
measure: To compare weight loss with leptin, ephedrine and caffeine combination.
timeFrame: 28 Weeks
measure: To compare the changes in insulin, with leptin alone.
timeFrame: 28 Weeks
measure: To compare the changes in insulin, with caffeine with ephedrine alone
timeFrame: 28 Weeks
measure: To compare the changes in insulin, with leptin , ephedrine and caffeine combination.
timeFrame: 28 Weeks
measure: To compare the changes in triglycerides, with leptin alone.
timeFrame: 28 Weeks
measure: To compare the changes in triglycerides, caffeine with ephedrine alone.
timeFrame: 28 Weeks
measure: To compare the changes in triglycerides, with leptin , ephedrine and caffeine combination
timeFrame: 28 Weeks
measure: To compare the changes in cholesterol, with leptin alone.
timeFrame: 28 Weeks
measure: To compare the changes in cholesterol, caffeine with ephedrine alone.
timeFrame: 28 Weeks
measure: To compare the changes in cholesterol with leptin , ephedrine and caffeine combination
timeFrame: 28 Weeks
measure: To compare the changes in HDL cholesterol, with leptin alone.
timeFrame: 28 Weeks
measure: To compare the changes in HDL cholesterol, caffeine with ephedrine alone.
timeFrame: 28 Weeks
measure: To compare the changes in HDL cholesterol, with leptin , ephedrine and caffeine combination
timeFrame: 28 Weeks
measure: To compare the changes in LDL cholesterol, with leptin alone.
timeFrame: 28 Weeks
measure: To compare the changes in LDL cholesterol, caffeine with ephedrine alone.
timeFrame: 28 Weeks
measure: To compare the changes in LDL cholesterol, with leptin , ephedrine and caffeine combination
timeFrame: 28 Weeks
measure: To compare the changes in glucose, with leptin alone.
timeFrame: 28 Weeks
measure: To compare the changes in glucose, caffeine with ephedrine alone.
timeFrame: 28 Weeks
measure: To compare the changes in glucose, with leptin , ephedrine and caffeine combination
timeFrame: 28 Weeks
measure: To compare the changes in uric acid, with leptin alone.
timeFrame: 28 Weeks
measure: To compare the changes in uric acid, caffeine with ephedrine alone.
timeFrame: 28 Weeks
measure: To compare the changes in uric acid, with leptin , ephedrine and caffeine combination
timeFrame: 28 Weeks
measure: To compare the changes in Alanine Aminotransferase (ALT )with leptin alone.
timeFrame: 28 Weeks
measure: To compare the changes in Alanine Aminotransferase (ALT ) caffeine with ephedrine alone.
timeFrame: 28 Weeks
measure: To compare the changes in Alanine Aminotransferase (ALT ) with leptin , ephedrine and caffeine combination
timeFrame: 28 Weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
citation: Liu AG, Smith SR, Fujioka K, Greenway FL. The effect of leptin, caffeine/ephedrine, and their combination upon visceral fat mass and weight loss. Obesity (Silver Spring). 2013 Oct;21(10):1991-6. doi: 10.1002/oby.20416. Epub 2013 Jun 11.