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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: caffeine and ephedrine
* Drug: Leptin A
* Drug: caffeine, ephedrine, and leptin A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: caffeine and ephedrine<br>Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily. | Drug: caffeine and ephedrine<br>* Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.<br>|
| Experimental: leptin A<br>Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day. | Drug: Leptin A<br>* Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.<br>|
| Experimental: caffeine, ephedrine, and leptin A<br>Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily. | Drug: caffeine, ephedrine, and leptin A<br>* Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the loss of fat and lean tissue with leptin alone. |  | 28 Weeks | 
| To compare the loss of fat and lean tissue with caffeine with ephedrine alone. |  | 28 Weeks | 
| compare the loss of fat and lean tissue with leptin, ephedrine and caffeine combination. |  | 28 Weeks | 
| To compare weight loss with leptin alone. |  | 28 Weeks | 
| To compare weight loss caffeine with ephedrine alone. |  | 28 Weeks | 
| To compare weight loss with leptin, ephedrine and caffeine combination. |  | 28 Weeks | 
| To compare the changes in insulin, with leptin alone. |  | 28 Weeks | 
| To compare the changes in insulin, with caffeine with ephedrine alone |  | 28 Weeks | 
| To compare the changes in insulin, with leptin , ephedrine and caffeine combination. |  | 28 Weeks | 
| To compare the changes in triglycerides, with leptin alone. |  | 28 Weeks | 
| To compare the changes in triglycerides, caffeine with ephedrine alone. |  | 28 Weeks | 
| To compare the changes in triglycerides, with leptin , ephedrine and caffeine combination |  | 28 Weeks | 
| To compare the changes in cholesterol, with leptin alone. |  | 28 Weeks | 
| To compare the changes in cholesterol, caffeine with ephedrine alone. |  | 28 Weeks | 
| To compare the changes in cholesterol with leptin , ephedrine and caffeine combination |  | 28 Weeks | 
| To compare the changes in HDL cholesterol, with leptin alone. |  | 28 Weeks | 
| To compare the changes in HDL cholesterol, caffeine with ephedrine alone. |  | 28 Weeks | 
| To compare the changes in HDL cholesterol, with leptin , ephedrine and caffeine combination |  | 28 Weeks | 
| To compare the changes in LDL cholesterol, with leptin alone. |  | 28 Weeks | 
| To compare the changes in LDL cholesterol, caffeine with ephedrine alone. |  | 28 Weeks | 
| To compare the changes in LDL cholesterol, with leptin , ephedrine and caffeine combination |  | 28 Weeks | 
| To compare the changes in glucose, with leptin alone. |  | 28 Weeks | 
| To compare the changes in glucose, caffeine with ephedrine alone. |  | 28 Weeks | 
| To compare the changes in glucose, with leptin , ephedrine and caffeine combination |  | 28 Weeks | 
| To compare the changes in uric acid, with leptin alone. |  | 28 Weeks | 
| To compare the changes in uric acid, caffeine with ephedrine alone. |  | 28 Weeks | 
| To compare the changes in uric acid, with leptin , ephedrine and caffeine combination |  | 28 Weeks | 
| To compare the changes in Alanine Aminotransferase (ALT )with leptin alone. |  | 28 Weeks | 
| To compare the changes in Alanine Aminotransferase (ALT ) caffeine with ephedrine alone. |  | 28 Weeks | 
| To compare the changes in Alanine Aminotransferase (ALT ) with leptin , ephedrine and caffeine combination |  | 28 Weeks |