Rejuvant™ Safety and Biomarker Study

NCT04821401 | Completed

• 1 other identifier: PDLH-2019-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging Well

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Safety Vital Signs

  9 months

• Safety Laboratory Assessments

  9 months

• Additional Laboratory Tests

  9 months

Other Outcomes (2)

• Metabolic Screen

  9 months

• Saliva Sample for DNA methylation analysis

  9 months

Study Arms (4)

Males study product

EXPERIMENTAL

25 men will be randomized to Rejuvant

Dietary Supplement: Rejuvant

Males placebo

PLACEBO COMPARATOR

25 man will be randomized to placebo

Dietary Supplement: Placebo

Females study product

EXPERIMENTAL

25 women will be randomized to Rejuvant

Dietary Supplement: Rejuvant

Females placebo

PLACEBO COMPARATOR

25 women will be randomized to placebo

Dietary Supplement: Placebo

Interventions

Rejuvant DIETARY_SUPPLEMENT

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

Females study product; Males study product

Placebo DIETARY_SUPPLEMENT

Matching placebo tablets are composed of Cellulose, Carnauba wax and/or rice bran wax (to match the specs), stearic acid, magnesium stearate and silica.

Females placebo; Males placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Males 45 to 75 years old Postmenopausal Females up to age 75
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ponce De Leon Health: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The medical assistant conducting clinical visits will receive two binders with sets of sequentially numbered, Kit Assignment Forms (n = 50) - one binder for men and one binder for women. For each new participant, the assistant will enter the participant identification # on the next Kit Assignment Form which contains the Kit # to be assigned to the new participant. The kits (contain either the dietary supplement or the placebo) were assigned either dietary supplement or placebo per the order of the randomization list generated by www.randomization.com
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled trial in adult men ages 45-75 years and postmenopausal women up to age 75 years

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 29, 2021
• Study Start: February 7, 2020
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)