Rejuvant™ Safety and Biomarker Study
- Conditions
- Aging Well
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Rejuvant
- Registration Number
- NCT04821401
- Lead Sponsor
- Ponce De Leon Health
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Males placebo Placebo 25 man will be randomized to placebo Females study product Rejuvant 25 women will be randomized to Rejuvant Females placebo Placebo 25 women will be randomized to placebo Males study product Rejuvant 25 men will be randomized to Rejuvant
- Primary Outcome Measures
Name Time Method Primary Outcome CRP, hs-CRP 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
- Secondary Outcome Measures
Name Time Method Additional Laboratory Tests 9 months At Day 1, Month 3, Month 6, and Month 9 visits, laboratory assessments will be completed for Uric Acid and Hemoglobin A1C
Safety Vital Signs 9 months The secondary objective is to determine the safety of oral administration of Rejuvant products through assessments of height (Day 1 only), weight, blood pressure, heart rate, and temperature at Day 1, Month 3, Month 6, and Month 9 visits
Safety Laboratory Assessments 9 months At Day 1, Month 3, Month 6, and Month 9 visits, laboratory assessments will be completed including Complete Blood Count, Comprehensive Metabolic Panel, and Lipid Panel
Trial Locations
- Locations (1)
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States