The Safety and Efficacy Study of RiaGev in Healthy Adults

This is an interventional other trial for Metabolic Syndrome focused on measuring NAD+, ATP, Glutathione, Cortisol, Exercise Read More

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.