NCT01710722已完成不适用
The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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/
- •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.
研究组 & 干预措施
caffeine and ephedrine
Experimental
Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.
干预措施: caffeine and ephedrine (Drug)
leptin A
Experimental
Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.
干预措施: Leptin A (Drug)
caffeine, ephedrine, and leptin A
Experimental
Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.
干预措施: caffeine, ephedrine, and leptin A (Drug)
结局指标
主要结局
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.
时间窗: 28 weeks
次要结局
- To compare the changes in triglycerides, with leptin alone.(28 Weeks)
- 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, 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)
研究者
Frank Greenway
Principal Investigator
Pennington Biomedical Research Center
研究点 (1)
Loading locations...
相似试验
已完成
2 期
"Pecos" B-adrenergic and PPAR-G Stimulation Upregulates Lipid Metabolism in Human Subcutaneous FatObesityNCT00377975Pennington Biomedical Research Center96
已完成
不适用
Treatment of Low Metabolic Rate Following Bariatric SurgeryMorbid ObesityNCT01596907Oregon Weight Loss Surgery, LLC218
已完成
4 期
Use of Medication to Improve Weight Loss in Suboptimal Early Responders to Behavioral TreatmentObesityNCT03779048University of Pennsylvania147
已完成
不适用
Dietary Intervention Examining Tracking With Mobile DevicesObesityNCT02632461University of South Carolina81
已完成
2 期
An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese SubjectsObesityNCT01666691Zafgen, Inc.160