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The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man

Information source: Pennington Biomedical Research Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: caffeine and ephedrine (Drug); Leptin A (Drug); caffeine, ephedrine, and leptin A (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pennington Biomedical Research Center

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.

Clinical Details

Official title: The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: 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.

Secondary outcome:

Compare the loss of fat and lean tissue with leptin alone.

To compare the loss of fat and lean tissue with caffeine with ephedrine alone.

compare the loss of fat and lean tissue with leptin, ephedrine and caffeine combination.

To compare weight loss with leptin alone.

To compare weight loss caffeine with ephedrine alone.

To compare weight loss with leptin, ephedrine and caffeine combination.

To compare the changes in insulin, with leptin alone.

To compare the changes in insulin, with caffeine with ephedrine alone

To compare the changes in insulin, with leptin , ephedrine and caffeine combination.

To compare the changes in triglycerides, with leptin alone.

To compare the changes in triglycerides, caffeine with ephedrine alone.

To compare the changes in triglycerides, with leptin , ephedrine and caffeine combination

To compare the changes in cholesterol, with leptin alone.

To compare the changes in cholesterol, caffeine with ephedrine alone.

To compare the changes in cholesterol with leptin , ephedrine and caffeine combination

To compare the changes in HDL cholesterol, with leptin alone.

To compare the changes in HDL cholesterol, caffeine with ephedrine alone.

To compare the changes in HDL cholesterol, with leptin , ephedrine and caffeine combination

To compare the changes in LDL cholesterol, with leptin alone.

To compare the changes in LDL cholesterol, caffeine with ephedrine alone.

To compare the changes in LDL cholesterol, with leptin , ephedrine and caffeine combination

To compare the changes in glucose, with leptin alone.

To compare the changes in glucose, caffeine with ephedrine alone.

To compare the changes in glucose, with leptin , ephedrine and caffeine combination

To compare the changes in uric acid, with leptin alone.

To compare the changes in uric acid, caffeine with ephedrine alone.

To compare the changes in uric acid, with leptin , ephedrine and caffeine combination

To compare the changes in Alanine Aminotransferase (ALT )with leptin alone.

To compare the changes in Alanine Aminotransferase (ALT ) caffeine with ephedrine alone.

To compare the changes in Alanine Aminotransferase (ALT ) with leptin , ephedrine and caffeine combination

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

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808, United States
Additional Information

Starting date: February 2001
Last updated: October 17, 2012

Page last updated: August 20, 2015

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