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 RiaGev™ via evaluation of NAD+, ATP, glucose, insulin, glutathione, and cortisol levels in healthy adults of ages 36-65.
Who can participate
Age range
36 Years – 65 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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