Clinical trial NCT04821401: Rejuvant™ Safety and Biomarker Study
Official title: Rejuvant™ Safety and Biomarker Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Well
Lead sponsor: Ponce De Leon Health
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, double-blind, placebo-controlled trial in adult men ages 45-75 years and postmenopausal women up to age 75 years
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Men between the ages of 45 and 75 years
2. 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

Exclusion Criteria:

1. Diabetes as determined by the presence of EMR based diagnosis including prescribed any DM medications
2. Diagnosed with severe mental illness, substance abuse disorders per EMR
3. Diagnosed with congestive heart disease per EMR
4. Had a myocardial infarction in the previous year per EMR
5. EMR based Diagnosis of any Cancer in the past 5 years
6. EMR based diagnosis of morbid obesity or anorexia nervosa
7. Hospitalized in the previous 12 months
8. Active smoking

Primary outcomes:
measure: Primary Outcome CRP, hs-CRP
timeFrame: 9 months
Secondary outcomes:
measure: Safety Vital Signs
timeFrame: 9 months
measure: Safety Laboratory Assessments
timeFrame: 9 months
measure: Additional Laboratory Tests
timeFrame: 9 months
Other outcomes:
measure: Metabolic Screen
timeFrame: 9 months
measure: Saliva Sample for DNA methylation analysis
timeFrame: 9 months
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
References: