ISRCTN10458693已完成不适用
Capsaicinoids supplementation reduces appetite and body circumferences in healthy men and women: a placebo controlled randomized double blind study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28235621 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30123516
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Willing to sign informed consent form
- •2. Male and Females aged 18-56 years, normal healthy individuals
- •3. BMI of 24.5-29.5 kg/m
- •4. Participant has not used any ergogenic aids within the previous 6 months of the start of the
- •5. Participant is willing and able to comply with protocol
- •6. Participant is apparently healthy and free from disease, as determined by a health history
- •questionnaire
- •7. Participant agrees to abstain from strenuous activity 24-48 hours prior to each testing visit
- •8. Participant agrees to be fasted for 12 hours prior to each testing visit
- •9. Participant agrees to refrain from smoking, caffeine, and tobacco for 12-hours prior to each
- •testing visit
- •10. Participant agrees to abstain from consuming alcohol 24-hours before each testing visit
- •11. Participant has provided written and dated informed consent to participate in the study
- •12. Participant is currently not pregnant or does not plan to become pregnant during the duration of the study
排除标准
- •1. Women who are pregnant, lactating within 6 weeks before the study start and during study, or planning to become pregnant 3 months before or during the study
- •2. Post menopausal women on hormone replacement therapy (HRT) for less than 90 days prior to randomization
- •3. Uncontrolled hypertension as defined by a blood pressure of 150/90 on two or more occasions or use of antihypertensive medications which may affect energy expenditure including alpha blockers, beta blockers, angiotensin receptor blockers or inhibitors of angiotensin converting enzyme
- •4. Current use of tobacco products, marijuana, amphetamines, cocaine or intravenous drug use
- •5. Chronic ethanol use (> 3 drinks /day)
- •6. Endocrine disorders including hypo or hyperthyroidism (including subclinical disease), Cushings
- •disease, growth hormone deficiency or other pituitary diseases
- •7. Chronic renal impairments (serum creatinine 180 mmol/liter), active liver disease;
- •8. Moderate to severe peripheral vascular disease
- •9. Severe chronic obstructive pulmonary disease, congestive heart failure (New York Heart
- •Association 2), angina requiring nitrates
- •10. Use of other medications to treat obesity including medications obtained over the counter or
- •internet, orlistat (Xenical, Alli), sibutramine (Meridia), or phentermine (Adipex P) within the past
- •11. History of an eating disorder including anorexia or bulimia
- •12. History of surgery for the treatment of obesity (gastric banding, gastric bypass)
- •13. Diagnosis of type 1 or type 2 diabetes mellitus according to American Diabetes Association
- •14. Have any known metabolic disorder including heart disease, arrhythmias, diabetes, thyroid
- •disease, or hypogonadism
- •15. Have taken ergogenic levels of nutritional supplements that may affect muscle mass or aerobic
- •capacity (e.g., creatine, HMB) or anabolic/catabolic hormone levels (e.g., androstenedione,
- •DHEA, etc.) within 6 months prior to the start of the study
- •16. Have any absolute or relative contraindication for exercise testing or prescription as outlined by
- •the American College of Sports Medicine
- •17. Report any unusual adverse events associated with this study that in consultation with the
- •supervising physician recommends removal from the study
- •18. Have consumed any dietary supplements (excluding multivitamins, including herbal
- •supplements for weight loss, or any other metabolic condition) 1 month prior to the study;
- •19. Have completed participation in any other clinical trial during the past 6 months;
- •20. Have a strong history of food or drug allergy of any kind
- •21. Any other condition in which principal investigator thinks may jeopardize the study;
- •22. Taking any satiety, diet or sport shake, powder or drink
- •23. Use of systemic corticosteroids such as oral/injectable hydrocortisonestable maintenance or low dose for >12 weeks
- •24. Use of statins (or any other medication for the treatment of hypercholesterolemia) such as
- •atrovastatin (Lipitor), rosuvastatin (Crestor), simvastatin (Zocor), gemfibrozil (Lopid), etc
- •25. Any weight loss regimens, and intake of cholesterol lowering supplements such as fish oil
- •capsules, phytoestrogens, soy lecithin or any polyphenols
- •26. Use of prescription antacids or anti-inflammatory medications on a regular basis. If acute
- •intake, medication should not be used with 1 week of the test day
- •27. Use of drugs acting on the gut such as ezetimibe (Zetia), bile-acid binding resins and orlistat (Xenical)
- •28. Immunocompromised individuals such as subject
研究者
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