The Safety and Efficacy Study of RiaGev in Healthy Adults

NCT04483011 | Unknown Results DMC

• 1 other identifier: 19RNHB(1918)
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This current randomized, double-blind, comparator-controlled, cross over study investigates the efficacy and safety of RiaGev™ via evaluation of NAD+, ATP, glucose, insulin, glutathione, and cortisol levels in healthy adults of ages 36-65.

Conditions

Metabolic Syndrome; Premature Aging

Keywords

NAD+; ATP; Glutathione; Cortisol; Exercise

Outcome Measures

Primary Outcomes (3)

• Whole Blood NAD+ Level Change Over Baseline After Supplementation

  Whole blood NAD+ concentration are measured at Day 1, Day 3, Day 5, and Day 8. A NAD+ Level change over baseline (Day 1) is calculated by subtracting the NAD+ level at Day 1 ( e.g Day 5 over Day 1 = Day 5 - Day 1). The significance of change (p value) is calculated comparing within RiaGev or Comparator group, and between RiaGev and Comparator groups.

  Day 1 to Day 8

• Whole Blood NADP+ Level Change Over Baseline After Supplementation

  Whole blood NADP+ concentration are measured at Day 1, Day 3, Day 5, and Day 8. NADP+ level changes over baseline (Day 1) are calculated by substracting NADP+ level at Day 1. The significance of change (p values) are calculated comparing changes within and between RiaGev and Comparator groups.

  Day 1 to Day 8

• Whole Blood NAD+ Plus NADP+ Level Change Over Baseline

  The change in whole blood NAD+ plus NADP+ levels from Day 1 baseline to Day 8 when supplemented with RiaGev™ or comparator. The parameter is measured at Day 1, Day 3, Day 5, and Day 8. A change over baseline is calculated by subtracting Day 1 value. The significance of changes (p value) are calculated by comparing within and between RiaGev and Comparator groups.

  Day 1 to 8

Secondary Outcomes (6)

• Serum Glucose Change After RiaGev Supplementation Assessed by OGTT

  7 days

• Serum Insulin Change After RiaGev Supplementation Assessed by OGTT

  7 days

• Serum Glutathione (GSH + GSSG) Change Over Baseline After RiaGev Supplementation

  7 days

• Serum High Energy Phosphate (ATP + ADP) Concentration After RiaGev Supplementation

  7 days

• The Waking Salivary Cortisol Level After RiaGev Supplementation

  7 days

Other Outcomes (3)

• The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator

  7 days

• The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.

  7 days

• The Number of Out-of-norm Vital Signs When Supplemented With RiaGev or Comparator

  7 days

Study Arms (2)

RiaGev

EXPERIMENTAL

RiaGev, 2000mg, BID

Dietary Supplement: RiaGev

Comparator

ACTIVE COMPARATOR

Comparator matched to RiaGev, BID

Dietary Supplement: RiaGev

Interventions

RiaGev DIETARY_SUPPLEMENT

Dietary supplementation

Comparator; RiaGev

Eligibility Criteria

• Age: 36 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and females between the ages of 35 and 65 years of age, inclusive
• BMI between 18.5 to 29.9 kg/m2, inclusive
• Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening
• Or,
• Females of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Healthy as determined by laboratory results, medical history, physical exam and EKG
• Agrees to avoid supplementation with tryptophan and vitamin B3 or its derivatives (niacin, nicotinic acid, niacinamide) one week prior to randomization and during the study
• Ability to complete maximal and submaximal exercise tests
• Agrees to maintain current diet and activity level throughout the study
• Agrees to comply to all study procedures

You may not qualify if:

• Women who are pregnant, breast feeding, or planning to become pregnant during the trial
• Allergy or sensitivity to investigational product's ingredients or standard meal provided
• Current or ex-smokers within the past year
• Major surgery within the past 3 months which may impact the study outcomes to be assessed by the QI.
• Untreated/unresolved/uncontrolled cardiovascular disease. Participants with no significant cardiovascular event in the past 1 year and on stable medication may be included after assessment by the QI on a case by case basis
• Self reported current or pre-existing thyroid condition. Treatment on a stable dose medication for over 3 months will be reviewed on a case-by-case basis by the QI
• Current or history of hypertension.
• Type I or Type II diabetes
• Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Self reported of any autoimmune disease or immune-compromised
• Self reported by subjects of being HIV or Hepatitis B/C positive
• History or currently with kidney and liver diseases assessed by QI on a case by case basis, with the exception of history of kidney stones symptom free for 1 year
• Known medical or psychological condition that, in the qualified investigator's opinion, could interfere with study participation
• Significant gastrointestinal disease (examples include but are not limited to Celiac disease and inflammatory bowel disease)
• Self reported of bleeding disorders.

Sponsors & Collaborators

• Bioenergy Life Science, Inc.: lead
• KGK Science Inc.: collaborator
• University of Washington: collaborator

Study Sites (1)

Prism Research, Inc.

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Aging, Premature; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Alex Xue, Chief Technology Officer
• Organization: Bioenergy Life Science, Inc.

alex.xue@bioenergyls.com

763-746-0032

Study Officials

• Malkanthi Evans, Ph.D

  KGK Science Inc.

  STUDY CHAIR

• Trisha Shamp, PA-C, Ph.D

  Prism Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, comparator-controlled, cross-over

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 23, 2020
• Study Start: October 25, 2019
• Primary Completion: July 30, 2020
• Study Completion: November 30, 2020
• Last Updated: November 25, 2020
• Results First Posted: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)