CTRI/2019/12/022514已完成不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- To compare the efficacy of Uthever NMN supplementation in terms of stimulation of NAD+ metabolism
研究概览
简要总结
| Sixty-six healthy male or female middle aged or older subjects will be assigned in 1:1 ratio to treatment with the test product, Uthever (NMN supplement) or Placebo in this double-blind, randomized, placebo-controlled study. All 66 enrolled subjects will be instructed to take two capsules of either Uthever (NMN supplement) or Placebo once a day after breakfast for 60 days daily. Subjects will be required to use diaries to document the date and time of study treatments including any missed doses and the occurrence of any adverse events. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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 participant’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.
结局指标
主要结局
To compare the efficacy of Uthever NMN supplementation in terms of stimulation of NAD+ metabolism
时间窗: To compare the efficacy of Uthever NMN supplementation in terms of stimulation of NAD+ metabolism
次要结局
- To assess and compare the safety and tolerability of the formulation(Visit 1, visit 2, visit 3, visit 4)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Multi-center, Randomized, Double-blind, Parallel, Placebo-Controlled, Phase ? Clinical Trial to Evaluate Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 PatientsKCT0005834Shin Poong Pharm110
进行中（未招募）
不适用
A multicenter, randomised, double- blind, between-patient, dose finding study to assess the safety, tolerability and efficacy of three different dosages (500, 1000 and 2000 mcg/g) of ABIO 12/01 gel, in comparison to an open active treatment, after a five-day vaginal administration to females with a confirmed clinical diagnosis of vulvovaginal candidiasis.MedDRA version: 6.1Level: PTClassification code 10046898VULVOVAGINAL CANDIDIASISEUCTR2005-001360-31-ITABIOGEN PHARMA200
招募中
3 期
A Multicentre, Randomised, Double-blind, Parallel-group, Placebo controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)NL-OMON54266Astra Zeneca3
进行中（未招募）
1 期
A study to evaluate if benralizumab may be beneficial in the treatment of Hypereosinophilic Syndrome (HES)Hypereosinophilic Syndrome (HES)MedDRA version: 20.0Level: PTClassification code 10048643Term: Hypereosinophilic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2019-002039-27-ITASTRAZENECA AB120
进行中（未招募）
1 期
A study to evaluate if benralizumab may be beneficial in the treatment of Hypereosinophilic Syndrome (HES)Hypereosinophilic Syndrome (HES)MedDRA version: 20.0Level: PTClassification code 10048643Term: Hypereosinophilic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2019-002039-27-DEAstraZeneca AB120