CTRI/2019/12/022514已完成未知
A Multicenter, Randomized, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN Supplement), an Orally Administered Supplementation in Middle Aged and Older Adults - EFFE-CT-01
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 66
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.Male/females of 40 to 65 years of age
- •2.Body Mass Index (BMI) between 18.5 and 35 kg/m2
- •3.Able to provide written Informed Consent
- •4.Able to follow verbal and written study directions
- •5.Must not be taking or be willing to take any supplements containing any form of niacin for seven days prior to baseline and for the duration of the study.
- •6.Able to maintain consistent diet and lifestyle habits throughout the study
- •7.Male and female subjects must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study
- •8.Willing to consume assigned dietary supplements for 2 months
排除标准
- •1.Participants on current use of prescription or over-the-counter nicotinic acid
- •2.Use of statin drugs
- •3.Having used any tobacco product or used a recreational drug in the past 6 months
- •4.Having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator
- •5.Documented presence of atherosclerotic disease and/or cardiopulmonary disease
- •6.History of drug or alcohol abuse
- •7.History of unstable depression or mental illness within the last 6 months for which the investigator believes could impact the participantâ??s ability to comply with study requirements
- •8.Unwilling to discontinue use of conventional multivitamin/mineral or other supplements at least two weeks prior to the study start
- •9.Participating in or planning to begin a weight loss diet during the study period
- •10.Chronic use of over-the-counter medication which would interfere with study endpoints
- •11.Lifestyle or schedule incompatible with the study protocol
- •12.Known hypersensitivity to the drug components used during the study
- •13.Women with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding
- •14.Other diseases or medications, according to the investigator, that would interfere directly in the results of the study or jeopardize the health of the participant.
- •15.Currently, or within the past 30 days, enrolled in a different clinical investigation
- •16.Inability to provide a venous blood sample
- •17.Unable or unwilling to provide written informed consent for participation in study
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