A Pilot Study of the Effect of a Dietary Herbal Supplement Containing Capsaicin or Placebo on Satiety, Metabolic Rate and Food Intake in Healthy Adults.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Resting Metabolic Rate
研究概览
简要总结
Comparison of Capsimax™ 2mg and 4mg of capsicum extract vs. placebo on metabolic rate and satiety.
详细描述
Capsimax™ is a capsicum extract in a bead technology to avoid oral and gastric burning. Capsimax™ 2mg, Capsimax™ 4 mg and placebo was initially given as a single dose on an empty stomach with measures of metabolic rate, and satiety before and after and food intake at 1 hour after Capsimax™.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Supplement and placebo capsules with identical appearance
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 25 and 40 kg/m2 inclusive
- •If of child-bearing potential, use of effective contraception
排除标准
- •Subjects excluded will:
- •Have received an investigational product in another trial within 30 days of enrollment.
- •Have lost 10 or more pounds in the 3 months prior to randomization and maintained the weight loss.
- •Use tobacco products
- •Use a nicotine patch or gum.
- •Take regular medication other than oral contraceptives or estrogen replacement therapy.
- •Take products containing ephedra or medications known to increase metabolic rate like stimulants taken for attention deficit disorder.
- •Not eat at regular mealtimes.
- •Have a history of alcohol or drug abuse in the past year.
- •Nurse a baby or be a member of a vulnerable population including adults unable to consent, pregnant women, prisoners or minors.
- •Have a clinically significant history of diabetes, high blood pressure (>140/90), thyroid disease, heart disease, kidney disease or liver disease.
- •Have a known allergy to capsaicin caffeine, piperine or niacin.
- •Have clinically significant laboratory findings in the opinion of the investigator.
- •Score greater than 13 on the restraint scale of the 3-factor eating questionnaire.
研究组 & 干预措施
Capsimax 2 mg
single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
干预措施: Capsimax (Dietary Supplement)
Placebo
single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
干预措施: Placebo (Dietary Supplement)
Capsimax 4 mg plus 250 kcal meal
single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
干预措施: Capsimax (Dietary Supplement)
Capsimax 4 mg plus 250 kcal meal
single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
干预措施: Meal (Other)
Placebo plus 250 kcal meal
single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
干预措施: Placebo (Dietary Supplement)
Placebo plus 250 kcal meal
single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
干预措施: Meal (Other)
结局指标
主要结局
Resting Metabolic Rate
时间窗: up to 5 hours
Metabolic cart measurement difference before and after intervention
次要结局
- Satiety by Visual Analog Scale (hunger, fullness, prospective food intake and satisfaction)(Baseline to 4 hours)
- Food Intake(1 hour after intervention)
研究者
Frank Greenway
Medical Director and Professor
Pennington Biomedical Research Center