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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
caffeine and ephedrine
Leptin A
caffeine, ephedrine, and leptin A
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

caffeine and ephedrine

leptin A

caffeine, ephedrine, and leptin A

Arm Description

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

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

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

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2012
Last Updated
December 17, 2015
Sponsor
Pennington Biomedical Research Center
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01710722
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
February 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Amgen

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
caffeine and ephedrine
Arm Type
Experimental
Arm Description
Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.
Arm Title
leptin A
Arm Type
Experimental
Arm Description
Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.
Arm Title
caffeine, ephedrine, and leptin A
Arm Type
Experimental
Arm Description
Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.
Intervention Type
Drug
Intervention Name(s)
caffeine and ephedrine
Intervention Description
Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.
Intervention Type
Drug
Intervention Name(s)
Leptin A
Intervention Description
Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.
Intervention Type
Drug
Intervention Name(s)
caffeine, ephedrine, and leptin A
Intervention Description
Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.
Primary Outcome Measure Information:
Title
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.
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Compare the loss of fat and lean tissue with leptin alone.
Time Frame
28 Weeks
Title
To compare the loss of fat and lean tissue with caffeine with ephedrine alone.
Time Frame
28 Weeks
Title
compare the loss of fat and lean tissue with leptin, ephedrine and caffeine combination.
Time Frame
28 Weeks
Title
To compare weight loss with leptin alone.
Time Frame
28 Weeks
Title
To compare weight loss caffeine with ephedrine alone.
Time Frame
28 Weeks
Title
To compare weight loss with leptin, ephedrine and caffeine combination.
Time Frame
28 Weeks
Title
To compare the changes in insulin, with leptin alone.
Time Frame
28 Weeks
Title
To compare the changes in insulin, with caffeine with ephedrine alone
Time Frame
28 Weeks
Title
To compare the changes in insulin, with leptin , ephedrine and caffeine combination.
Time Frame
28 Weeks
Title
To compare the changes in triglycerides, with leptin alone.
Time Frame
28 Weeks
Title
To compare the changes in triglycerides, caffeine with ephedrine alone.
Time Frame
28 Weeks
Title
To compare the changes in triglycerides, with leptin , ephedrine and caffeine combination
Time Frame
28 Weeks
Title
To compare the changes in cholesterol, with leptin alone.
Time Frame
28 Weeks
Title
To compare the changes in cholesterol, caffeine with ephedrine alone.
Time Frame
28 Weeks
Title
To compare the changes in cholesterol with leptin , ephedrine and caffeine combination
Time Frame
28 Weeks
Title
To compare the changes in HDL cholesterol, with leptin alone.
Time Frame
28 Weeks
Title
To compare the changes in HDL cholesterol, caffeine with ephedrine alone.
Time Frame
28 Weeks
Title
To compare the changes in HDL cholesterol, with leptin , ephedrine and caffeine combination
Time Frame
28 Weeks
Title
To compare the changes in LDL cholesterol, with leptin alone.
Time Frame
28 Weeks
Title
To compare the changes in LDL cholesterol, caffeine with ephedrine alone.
Time Frame
28 Weeks
Title
To compare the changes in LDL cholesterol, with leptin , ephedrine and caffeine combination
Time Frame
28 Weeks
Title
To compare the changes in glucose, with leptin alone.
Time Frame
28 Weeks
Title
To compare the changes in glucose, caffeine with ephedrine alone.
Time Frame
28 Weeks
Title
To compare the changes in glucose, with leptin , ephedrine and caffeine combination
Time Frame
28 Weeks
Title
To compare the changes in uric acid, with leptin alone.
Time Frame
28 Weeks
Title
To compare the changes in uric acid, caffeine with ephedrine alone.
Time Frame
28 Weeks
Title
To compare the changes in uric acid, with leptin , ephedrine and caffeine combination
Time Frame
28 Weeks
Title
To compare the changes in Alanine Aminotransferase (ALT )with leptin alone.
Time Frame
28 Weeks
Title
To compare the changes in Alanine Aminotransferase (ALT ) caffeine with ephedrine alone.
Time Frame
28 Weeks
Title
To compare the changes in Alanine Aminotransferase (ALT ) with leptin , ephedrine and caffeine combination
Time Frame
28 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23686786
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.
Results Reference
derived

Learn more about this trial

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

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