Rejuvant™ Safety and Biomarker Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Primary Outcome CRP, hs-CRP
研究概览
简要总结
In this randomized, double-blind, placebo-controlled trial in adult men ages 45-65 years and postmenopausal women to age 75 years, the anti-inflammatory property of proprietary CaAKG based dietary supplements will be assessed by the measurement of C-reactive protein (CRP) as the primary endpoint. Secondary safety endpoints will be assessed by monitoring blood chemistry results and recorded adverse effects. In addition, the biological age of the participants will be determined by the level of DNA methylation measured from saliva samples.
An open label Sub-Study was conducted on eligible and consenting subjects who were assigned to the placebo. Assessments and endpoints remained the same as for the main study.
详细描述
This is a randomized, double-blind, placebo-controlled trial in adult men ages 45-65 years and postmenopausal women up to age 65 years to measure the effect that Rejuvant dietary supplement products have on inflammation by the measurement of C-Reactive Protein (CRP).
The study has four groups as outlined in Table 1. Groups 1-4 are divided by gender and each Group will receive the gender-specific investigational product or placebo.
Rejuvant and placebo tablets are 0.500" round and 0.290" thick. Groups 1 and 3 will take two tablets per day of the gender-specific investigational dietary supplement product. Groups 2 and 4 will take 2 placebo tablets per day. All Groups will take the investigational product for nine months. Participants will be assessed at four timepoints: Study Initiation (Day 1), Month 3, Month 6, and Month 9. At each visit weight, blood pressure, pulse, safety labs, CRP, blood chemistries, Hemoglobin A1C, and uric acid levels will be obtained, and the study questionnaire will be completed by each participant. These data will allow for an assessment of the antiinflammatory effects and the safety of the investigational dietary supplement products.
Additionally, up to 200 plasma metabolites will be measured. These data will be used to assess changes in participant metabolism over the course of the study. The blood chemistry and metabolite data may also be used to calculate the biological age of the participant by one or more published algorithms. DNA methylation analysis of saliva will determine the degree of DNA methylation (the cytosine of the CpG dinucleotide can be methylated). The degree of DNA methylation is correlated with aging and can be used as another measure of the biological age of the participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The medical assistant conducting clinical visits will receive two binders with sets of sequentially numbered, Kit Assignment Forms (n = 50) - one binder for men and one binder for women. For each new participant, the assistant will enter the participant identification # on the next Kit Assignment Form which contains the Kit # to be assigned to the new participant. The kits (contain either the dietary supplement or the placebo) were assigned either dietary supplement or placebo per the order of the randomization list generated by www.randomization.com
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men between the ages of 45 and 75 years
- •Postmenopausal Women up to age 75 years per EMR. Women should not have had a menstrual period for at least one year prior to enrollment into the study
排除标准
- •Diabetes as determined by the presence of EMR based diagnosis including prescribed any DM medications
- •Diagnosed with severe mental illness, substance abuse disorders per EMR
- •Diagnosed with congestive heart disease per EMR
- •Had a myocardial infarction in the previous year per EMR
- •EMR based Diagnosis of any Cancer in the past 5 years
- •EMR based diagnosis of morbid obesity or anorexia nervosa
- •Hospitalized in the previous 12 months
- •Active smoking
结局指标
主要结局
Primary Outcome CRP, hs-CRP
时间窗: 9 months
The primary objective is to observe the effect, if any, of Rejuvant products on the C-reactive protein level (CRP, hs-CRP). These tests will be done at Day 1, Month 3, Month 6, and Month 9
次要结局
- Additional Laboratory Tests(9 months)
- Safety Vital Signs(9 months)
- Safety Laboratory Assessments(9 months)