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

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT01710722

Collaborator

Amgen (Industry)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: caffeine and ephedrine Drug: Leptin A Drug: caffeine, ephedrine, and leptin A	N/A

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2001

Actual Primary Completion Date :

Feb 1, 2002

Actual Study Completion Date :

Feb 1, 2002

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: caffeine and ephedrine

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

Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.

Experimental: leptin A

Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.

Drug: Leptin A

Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.

Experimental: caffeine, ephedrine, and leptin A

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

Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

Pennington Biomedical Research Center
Amgen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Frank Greenway, Principal Investigator, Pennington Biomedical Research Center

ClinicalTrials.gov Identifier:

NCT01710722

Other Study ID Numbers:

PBRC 20034

First Posted:

Oct 19, 2012

Last Update Posted:

Dec 18, 2015

Last Verified:

Dec 1, 2015

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 18, 2015