The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rejuvant™ Safety and Biomarker Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04821401
Recruitment Status : Completed
First Posted : March 29, 2021
Last Update Posted : September 15, 2022
Sponsor:
Information provided by (Responsible Party):
Ponce De Leon Health

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.


Condition or disease Intervention/treatment Phase
Aging Well Dietary Supplement: Rejuvant Dietary Supplement: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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)
Masking Description: 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
Primary Purpose: Other
Official Title: Rejuvant™ Safety and Biomarker Study
Actual Study Start Date : February 7, 2020
Actual Primary Completion Date : February 14, 2022
Actual Study Completion Date : February 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: Males study product
25 men will be randomized to Rejuvant
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 Comparator: Males placebo
25 man will be randomized to placebo
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.

Experimental: Females study product
25 women will be randomized to Rejuvant
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 Comparator: Females placebo
25 women will be randomized to placebo
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.




Primary Outcome Measures :
  1. Primary Outcome CRP, hs-CRP [ Time Frame: 9 months ]
    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


Secondary Outcome Measures :
  1. Safety Vital Signs [ Time Frame: 9 months ]
    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

  2. Safety Laboratory Assessments [ Time Frame: 9 months ]
    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

  3. Additional Laboratory Tests [ Time Frame: 9 months ]
    At Day 1, Month 3, Month 6, and Month 9 visits, laboratory assessments will be completed for Uric Acid and Hemoglobin A1C


Other Outcome Measures:
  1. Metabolic Screen [ Time Frame: 9 months ]
    Blood samples taken during site visits Day 1, Month 3, Month 6, and Month 9 will be tested and analyzed by an independent laboratory

  2. Saliva Sample for DNA methylation analysis [ Time Frame: 9 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males 45 to 75 years old Postmenopausal Females up to age 75
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04821401


Locations
Layout table for location information
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Ponce De Leon Health
Layout table for additonal information
Responsible Party: Ponce De Leon Health
ClinicalTrials.gov Identifier: NCT04821401    
Other Study ID Numbers: PDLH-2019-01
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No