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

Pennington Biomedical Research Center

Status: Completed

Conditions: Obesity

Treatments: Drug: caffeine and ephedrine; Drug: caffeine, ephedrine, and leptin A; Drug: Leptin A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01710722

PBRC 20034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

caffeine and ephedrine

Experimental group

Description:

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

Treatment:

Drug: caffeine and ephedrine

leptin A

Experimental group

Description:

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

Treatment:

Drug: Leptin A

caffeine, ephedrine, and leptin A

Experimental group

Description:

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

Treatment:

Drug: caffeine, ephedrine, and leptin A