Rejuvant™ Safety and Biomarker Study
Condition: Aging Well
Study type: Interventional

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.
    

Intervention name(s): Rejuvant; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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; Matching placebo tablets are composed of Cellulose, Carnauba wax and/or rice bran wax (to match the specs), stearic acid, magnesium stearate and silica.
Allocation: Randomized
Intervention model: Parallel Assignment
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
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other