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Completed

NCT Number: NCT01710722

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

caffeine and ephedrine

Drug

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

Leptin A

Drug

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

caffeine, ephedrine, and leptin A

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Amgen

Registry information

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Oct 19, 2012
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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