A randomized, double-blind, placebo-controlled , cross over clinical study to evaluate the effect of CL19183 on the metabolic rate of overweight subjects

CLS Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Healthy male and female subjects aged between 20-39 years with body mass index (BMI) of 25-29.9 kg/m2.
•Subjects with sedentary lifestyle, no regular athletic or sports activities.
•Subjects willing to do exercise activity as per the study schedule.
•Normal thyroid hormone profile.
•Subjects who are willing to abstain from alcohol, coffee, tea, cola, energy drinks & chocolate for at least 24 hr prior to randomization day.
•Subjects who are non-smokers.
•Subject agrees to maintain diet tracker.
•Subject considered generally healthy as per health history and routine clinical investigations during screening.
•Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-ProveraÃ?Â®, or double-barrier and have a negative pregnancy test at the screening visit.
•Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.

•Subjects who were taking medications which affect the metabolic rate (e.g. antidepressants, beta-blockers, hormones, etc.).
•Subjects who lost or gained greater than 3kg body weight in past 3 months.
•Subjects underwent treatment for COVID-19 or tested positive during the study will be excluded.
•Subjects who are diabetic and/or hypertensive.
•Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
•Subjects taking medications for or suffering from a medical condition that could impact results related to metabolism (e.g., thyroid disorders, diabetes, mental disorders such as anxiety or depression, heart disease, arthritis, cancer).
•Subjects with HIV Positive.
•Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study.
•Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
•Any other condition that, in the opinion of the investigator, would adversely affect the subjectÃ¢â?¬•s ability to complete the study or its measures.
•Use of nutritional supplements (e.g., creatine, protein drinks, amino acids, or vitamins) or ergogenic aids and thermogenics within 30 days prior to the study.
•Subjects who are participated or currently participating in another clinical trial within 30 days prior to screening.

发起方

CLS Pvt Ltd