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

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ClinicalTrials.gov Identifier: NCT01710722
Recruitment Status : Completed
First Posted : October 19, 2012
Last Update Posted : December 18, 2015
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : February 2001
Actual Primary Completion Date : February 2002
Actual Study Completion Date : February 2002


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.




Primary Outcome Measures :
  1. 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 Measures :
  1. Compare the loss of fat and lean tissue with leptin alone. [ Time Frame: 28 Weeks ]
  2. To compare the loss of fat and lean tissue with caffeine with ephedrine alone. [ Time Frame: 28 Weeks ]
  3. compare the loss of fat and lean tissue with leptin, ephedrine and caffeine combination. [ Time Frame: 28 Weeks ]
  4. To compare weight loss with leptin alone. [ Time Frame: 28 Weeks ]
  5. To compare weight loss caffeine with ephedrine alone. [ Time Frame: 28 Weeks ]
  6. To compare weight loss with leptin, ephedrine and caffeine combination. [ Time Frame: 28 Weeks ]
  7. To compare the changes in insulin, with leptin alone. [ Time Frame: 28 Weeks ]
  8. To compare the changes in insulin, with caffeine with ephedrine alone [ Time Frame: 28 Weeks ]
  9. To compare the changes in insulin, with leptin , ephedrine and caffeine combination. [ Time Frame: 28 Weeks ]
  10. To compare the changes in triglycerides, with leptin alone. [ Time Frame: 28 Weeks ]
  11. To compare the changes in triglycerides, caffeine with ephedrine alone. [ Time Frame: 28 Weeks ]
  12. To compare the changes in triglycerides, with leptin , ephedrine and caffeine combination [ Time Frame: 28 Weeks ]
  13. To compare the changes in cholesterol, with leptin alone. [ Time Frame: 28 Weeks ]
  14. To compare the changes in cholesterol, caffeine with ephedrine alone. [ Time Frame: 28 Weeks ]
  15. To compare the changes in cholesterol with leptin , ephedrine and caffeine combination [ Time Frame: 28 Weeks ]
  16. To compare the changes in HDL cholesterol, with leptin alone. [ Time Frame: 28 Weeks ]
  17. To compare the changes in HDL cholesterol, caffeine with ephedrine alone. [ Time Frame: 28 Weeks ]
  18. To compare the changes in HDL cholesterol, with leptin , ephedrine and caffeine combination [ Time Frame: 28 Weeks ]
  19. To compare the changes in LDL cholesterol, with leptin alone. [ Time Frame: 28 Weeks ]
  20. To compare the changes in LDL cholesterol, caffeine with ephedrine alone. [ Time Frame: 28 Weeks ]
  21. To compare the changes in LDL cholesterol, with leptin , ephedrine and caffeine combination [ Time Frame: 28 Weeks ]
  22. To compare the changes in glucose, with leptin alone. [ Time Frame: 28 Weeks ]
  23. To compare the changes in glucose, caffeine with ephedrine alone. [ Time Frame: 28 Weeks ]
  24. To compare the changes in glucose, with leptin , ephedrine and caffeine combination [ Time Frame: 28 Weeks ]
  25. To compare the changes in uric acid, with leptin alone. [ Time Frame: 28 Weeks ]
  26. To compare the changes in uric acid, caffeine with ephedrine alone. [ Time Frame: 28 Weeks ]
  27. To compare the changes in uric acid, with leptin , ephedrine and caffeine combination [ Time Frame: 28 Weeks ]
  28. To compare the changes in Alanine Aminotransferase (ALT )with leptin alone. [ Time Frame: 28 Weeks ]
  29. To compare the changes in Alanine Aminotransferase (ALT ) caffeine with ephedrine alone. [ Time Frame: 28 Weeks ]
  30. To compare the changes in Alanine Aminotransferase (ALT ) with leptin , ephedrine and caffeine combination [ Time Frame: 28 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710722


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Amgen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01710722     History of Changes
Other Study ID Numbers: PBRC 20034
First Posted: October 19, 2012    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Ephedrine
Pseudoephedrine
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Adrenergic Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants