CTRI/2020/04/024679尚未招募未知
A Randomized, Double-Blind, Placebo-Controlled, Single dose, Cross-Over Study to Evaluate the Effect of a Dietary Supplement on Energy Expenditure Before, During and Following Low Intensity Exercise.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.BMI between 18.5 to 24.9 kg/m2
- •2.Subjects with normal TSH ( > 0.4 µIU/ml to < 5.5 µIU/ml).
- •3.Subject is in good health as determined by a health and exercise status questionnaire.
- •4.Subject will be untrained or recreationally trained
- •5.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form
排除标准
- •1.Subject has a significant history or current presence of treated or untreated bleeding disorder, metabolic (hyperlipidemia, hyperglycemia), musculoskeletal, diabetes mellitus, high blood pressure [systolic BP > 140 and/or diastolic BP > 90 mm Hg], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
- •2.Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study.
- •3.Subject has lost >=10 pounds (5 Kilograms) and maintained the weight loss or gained >=10 pounds (5 Kilograms) during the previous three months.
- •4.Subject does not eat meals at regular intervals.
- •5.Subject who is habituated to very spicy food in their diet
- •6.Subject has a history of alcohol or other drug abuse in the past year.
- •7.Subject regularly uses tobacco products.
- •8.Subject has had an abnormal electrocardiogram.
- •9.Subject regularly takes any of the prohibited concomitant medications listed in the protocol.
- •10.Subject has a known allergy or sensitivity to any ingredient in thermogenic supplement, including caffeine.
- •11.Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
- •12.Subject has a history of difficulty swallowing large pills or tablets.
- •13.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- •14.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
- •15. female subjects pregnant, lactating, planning a pregnancy during the study.
- •Female subjects
- •16.Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study treatment and for 4 weeks after the end of treatment.
研究者
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