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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: caffeine and ephedrine; Drug: Leptin A; Drug: caffeine, ephedrine, and leptin 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.

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Amgen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2001
• Primary Completion (Actual): February 1, 2002
• Study Completion (Actual): February 1, 2002

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (Estimate): October 19, 2012

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Caffeine; Ephedrine; Pseudoephedrine
• Other Study ID Numbers: PBRC 20034