The Safety and Efficacy Study of RiaGev in Healthy Adults

Status unconfirmed · Not applicable

Conditions studied: Metabolic Syndrome, Premature Aging

In brief

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.

Key facts

Study ID

NCT04483011

Run by

Bioenergy Life Science, Inc.

People needed

18

Starts

2019-10-25

Expected to finish

2020-11-30

Last updated by the study team

2020-11-25

Who can join

Age: 36 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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
• Has given voluntary, written, informed consent to participate in the study
• 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.

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.
• Current diagnosis of gout within past three months as per the QI's assessment
• Clinically significant abnormal laboratory results at screening as assessed by QI
• Current use of prescribed medications or over the counter supplements that may interfere with the IP assessed by QI (See Section 7.3)
• Alcohol consumption of >2 standard drinks/day or >14 drinks/week
• Alcohol or drug abuse within the past 12 months
• Use of medical marijuana
• Frequent use of recreational drugs within 6 months of baseline assessed as per QI
• Planned blood donation during or within 30 days following conclusion of clinical trial
• Participation in other clinical research trials 30 days prior to baseline
• Participants that are cognitively impaired and/or who are unable to give informed consent

Where it is running

• Prism Research, Inc. — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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