NCT04821401

Rejuvant™ Safety and Biomarker Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ponce De Leon Health · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Aging Well

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Rejuvant	Rejuvant tablets are sustained release tablets that release the active ingredients over 8-12 hours. Both product tablets are 0.500" round and 0.290" thick. AKG and AKG salts are grandfathered as GRAS compounds because these compounds were supplements prior to the Dietary Supplement Health and Education Act of 1994 ("DSHEA"). AKG and AKG salts are currently sold in the United States as supplements. The other components of the tablets are Vitamin A for the men's product and Vitamin D3 for the women's product. Vitamin A and Vitamin D are GRAS compounds per the FDA
DIETARY_SUPPLEMENT	Placebo	Matching placebo tablets are composed of Cellulose, Carnauba wax and/or rice bran wax (to match the specs), stearic acid, magnesium stearate and silica.

Timeline

• Start date: 2020-02-07
• Primary completion: 2022-02-14
• Completion: 2022-02-14
• First posted: 2021-03-29
• Last updated: 2022-09-15

Locations

1 site across 1 country: United States