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Trial · Interventional

Status unknownNot applicableResults postedRegistry data

The Safety and Efficacy Study of RiaGev in Healthy Adults

This trial does not test a peptide that PepBank tracks.

  • Measures Glutathione, does not give it. It appears in an outcome measure.

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
18 participants (actual)
Sponsor
Bioenergy Life Science, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
25 Oct 2019
Primary completion
30 Jul 2020
Completion
30 Nov 2020 (estimated)
First posted
23 Jul 2020
Last update posted
25 Nov 2020
Conditions
Metabolic Syndrome · Premature Aging

Timeline

1 trial · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. N/A

    The Safety and Efficacy Study of RiaGev in Healthy Adults

    NCT04483011

    25 Oct 2019 to est. 30 Nov 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • RiaGevDietary supplement

Arms2

  • Experimental

    RiaGev

    RiaGev, 2000mg, BID

  • Active comparator

    Comparator

    Comparator matched to RiaGev, BID

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Whole Blood NAD+ Level Change Over Baseline After Supplementation

    Time frame · Day 1 to Day 8

    Registry description

    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.

  2. Whole Blood NADP+ Level Change Over Baseline After Supplementation

    Time frame · Day 1 to Day 8

    Registry description

    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.

  3. Whole Blood NAD+ Plus NADP+ Level Change Over Baseline

    Time frame · Day 1 to 8

    Registry description

    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.

Secondary outcomes(6)
  1. Serum Glucose Change After RiaGev Supplementation Assessed by OGTT

    Time frame · 7 days

    Registry description

    The serum glucose as assessed by a standard Oral Glucose Tolerance Test (OGTT) on Day 1 and on Day 8 after 7-day supplementation with either RiaGev™ or comparator. Incremental Area Under the Curve (iAUC) is used as overall blood glucose. Serum glucose change is calculated by subtracting iAUC on Day 1 from iAUC on Day 8. The significance of change (p value) is calculated by comparing values on Day 8 and Day 1.

  2. Serum Insulin Change After RiaGev Supplementation Assessed by OGTT

    Time frame · 7 days

    Registry description

    Serum insulin is assessed by a standard Oral Glucose Tolerance Test (OGTT) on Day 1 and Day 8 after 7-day supplementation with either RiaGev™ or comparator. Serum insulin change is calculated by substracting its level on Day 1 from Day 8. The significance of change (p value) is calculated by comparing Day 1 and Day 8.

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

    Time frame · 7 days

    Registry description

    Total serum Glutathione (GSH + GSSG) is measured on Day 1, Day 3, Day 5 and Day 8. after a 7-day supplementation with either RiaGev™ or comparator. A change over baseline is calculated by subtracting glutathione level on Day 1 baseline (e g Day 5 over Day 1 = Day 5 - Day 1). The significance of change (p value) is calculated within the RiaGev or Comparator group.

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

    Time frame · 7 days

    Registry description

    Serum high energy phosphate (ATP + ADP) after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1, Day 3, Day 5, and Day 8. Comparison are made between the two groups. The significance (p value) is also calculated between the groups.

  5. The Waking Salivary Cortisol Level After RiaGev Supplementation

    Time frame · 7 days

    Registry description

    The salivary cortisol level after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1, 3, 5, and 8. The salivary cortisol level as well as change of salivary cortisol level over baseline (Day 1) are reported. Comparisons are make both between the RiaGev and Comparison groups as well as within RiaGev group against its Day 1 baseline. The corresponding significance (p value) will be calculated.

  6. The Change in Checklist Individual Strength (CIS) Questionnaire Outcome After a 7-day Supplementation With Either RiaGev™ or Comparator.

    Time frame · 7 days

    Registry description

    Checklist Individual Strength (CIS) Questionnaire was designed by the Dutch research team of Vercoulen et el, to measure fatigues. A standard CIS Questionnaire contains 20 questions, each scoring 1 to 7, total score 20 - 140, with higher score indicating more tiredness. Thus, a negative value in changing score (such as Day 5 - Day 1 baseline) means reduction of tiredness and verse versa.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Day 1 to Day 8

Whole Blood NAD+ Level Change Over Baseline After Supplementation

GroupValue (MicroMolar)Spread
RiaGev1.233.39
Comparator0.134.83
Primary outcomeMean· Day 1 to Day 8

Whole Blood NADP+ Level Change Over Baseline After Supplementation

GroupValue (microMolar)Spread
RiaGev1.301.72
Comparator0.852.49
Primary outcomeMean· Day 1 to 8

Whole Blood NAD+ Plus NADP+ Level Change Over Baseline

GroupValue (microMolar)Spread
RiaGev2.544.60
Comparator0.977.10
Secondary and other outcome results(5)
Secondary outcomeMean· 7 days

Serum Glucose Change After RiaGev Supplementation Assessed by OGTT

GroupValue ((mg/dL)*min)Spread
RiaGev17700.422525.30
Comparator876.251601.18
Secondary outcomeMean· 7 days

Serum Insulin Change After RiaGev Supplementation Assessed by OGTT

GroupValue ((microUnit/mL)*min)Spread
RiaGev4807.422419.04
Comparator4545.671915.67
Secondary outcomeMean· 7 days

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

GroupValue (microMolar)Spread
RiaGev61.85124.73
Comparator32.43130.37
Secondary outcomeMean· 7 days

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

GroupValue (microMolar)Spread
RiaGev327.1042.87
Comparator324.9458.55
Secondary outcomeMean· 7 days

The Waking Salivary Cortisol Level After RiaGev Supplementation

GroupValue (mcg/dL)Spread
RiaGev0.430.15
Comparator0.510.24

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
RiaGevRiaGev, 2000mg, BID RiaGev: Dietary supplementation0 / 180 / 181 / 18
ComparatorComparator matched to RiaGev, BID Comparator: Dietary ingredient0 / 170 / 171 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 36 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Healthy male and females between the ages of 35 and 65 years of age, inclusive 2. BMI between 18.5 to 29.9 kg/m2, inclusive 3. 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 4. Healthy as determined by laboratory results, medical history, physical exam and EKG 5. 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 6. Ability to complete maximal and submaximal exercise tests 7. Agrees to maintain current diet and activity level throughout the study 8. Agrees to comply to all study procedures 9. Has given voluntary, written, informed consent to participate in the study 10. Self-reported good sleeper at screening. Have a regular sleep cycle with a bedtime between the approximate hours of 9:00pm and 12:00am and regularly receive between 7-9 hours of sleep, and agrees to maintain this sleep schedule throughout the study. Exclusion Criteria: 1. Women who are pregnant, breast feeding, or planning to become pregnant during the trial 2. Allergy or sensitivity to investigational product's ingredients or standard meal provided 3. Current or ex-smokers within the past year 4. Major surgery within the past 3 months which may impact the study outcomes to be assessed by the QI. 5. 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 6. 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 7. Current or history of hypertension. 8. Type I or Type II diabetes 9. 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 10. Self reported of any autoimmune disease or immune-compromised 11. Self reported by subjects of being HIV or Hepatitis B/C positive 12. 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 13. Known medical or psychological condition that, in the qualified investigator's opinion, could interfere with study participation 14. Significant gastrointestinal disease (examples include but are not limited to Celiac disease and inflammatory bowel disease) 15. Self reported of bleeding disorders. 16. Current diagnosis of gout within past three months as per the QI's assessment 17. Clinically significant abnormal laboratory results at screening as assessed by QI 18. Current use of prescribed medications or over the counter supplements that may interfere with the IP assessed by QI (See Section 7.3) 19. Alcohol consumption of \>2 standard drinks/day or \>14 drinks/week 20. Alcohol or drug abuse within the past 12 months 21. Use of medical marijuana 22. Frequent use of recreational drugs within 6 months of baseline assessed as per QI 23. Planned blood donation during or within 30 days following conclusion of clinical trial 24. Participation in other clinical research trials 30 days prior to baseline 25. Participants that are cognitively impaired and/or who are unable to give informed consent 26. Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant.

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