The Safety and Efficacy Study of RiaGev in Healthy Adults (NCT04483011) | Clinical Trial Compass
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The Safety and Efficacy Study of RiaGev in Healthy Adults
United States18 participantsStarted 2019-10-25
Plain-language summary
This current randomized, double-blind, comparator-controlled, cross over study investigates the efficacy and safety of RiaGevâ„¢ via evaluation of NAD+, ATP, glucose, insulin, glutathione, and cortisol levels in healthy adults of ages 36-65.
Who can participate
Age range36 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Whole Blood NAD+ Level Change Over Baseline After Supplementation
Timeframe: Day 1 to Day 8
2
Whole Blood NADP+ Level Change Over Baseline After Supplementation
Timeframe: Day 1 to Day 8
3
Whole Blood NAD+ Plus NADP+ Level Change Over Baseline
✕. 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