Rejuvant™ Safety and Biomarker Study

Aging Well Clinical Trial

Official title:

Rejuvant™ Safety and Biomarker Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821401
• Other study ID #: PDLH-2019-01
• Status: Completed
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: February 14, 2022

Study information

• Verified date: September 2022
• Source: Ponce De Leon Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging Well

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Ponce De Leon Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolic Screen	Blood samples taken during site visits Day 1, Month 3, Month 6, and Month 9 will be tested and analyzed by an independent laboratory	9 months
Other	Saliva Sample for DNA methylation analysis	Saliva samples will be obtained at the Day 1, Month 3, Month 6 and Month 9 visits. The saliva will be used for measurement of the degree of DNA methylation	9 months
Primary	Primary Outcome CRP, hs-CRP	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	9 months
Secondary	Safety Vital Signs	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	9 months
Secondary	Safety Laboratory Assessments	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	9 months
Secondary	Additional Laboratory Tests	At Day 1, Month 3, Month 6, and Month 9 visits, laboratory assessments will be completed for Uric Acid and Hemoglobin A1C	9 months