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The Safety and Efficacy Study of RiaGev in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04483011
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : July 23, 2020
Sponsor:
Collaborators:
KGK Science Inc.
University of Washington
Information provided by (Responsible Party):
Bioenergy Life Science, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Chronic Fatigue Syndrome Premature Aging Dietary Supplement: RiaGev Not Applicable

Detailed Description:

Nicotinamide adenine dinucleotide (NAD+) is one of the essential cofactors required for the proper function of living cells, and depletion in NAD has been correlated to aging individuals as NAD is associated with oxidative stress and energy production. Per the Population Reference Bureau (PRB), it is estimated that by the year 2060, the number of Americans over the age of 65 will double to over 98 million. As well, over the years, there has been a continuous rise in obesity within older Americans, reaching 44% for women and 36% for men in the age range of 65-74. One of the most common chronic diseases that are accompanied by aging and obesity diabetes. In 2016 the WHO reported that approximately 1.6 million deaths were attributed to diabetes. Half of these individuals had high blood glucose before the age of 70. Hence it is crucial to actively control blood glucose and oxidative stress during one's midlife stage.

The investigating product RiaGev™ is the first and only commercially available product that contains Bioenergy Ribose® and vitamin B3. It increases NAD+ in the body efficiently to promote healthy mitochondria, active immunity, and cholesterol reduction. As a result, D-ribose is essential for healthy aging.

Bioenergy Ribose® is a 5-carbon carbohydrate (C5H10O5) called D-ribose designated as a Generally Recognized as Safe (GRAS) substance by the US Food and Drug Administration (FDA). It is produced via the pentose phosphate pathway (PPP), which is fundamental for adenosine triphosphate (ATP) production. The PPP is a rate-limiting step that makes use of a short supply enzyme called glucose-6-phosphate dehydrogenase (G-6-PDH). Supplementation of D-ribose can bypass the PPP and directly contribute to ATP production. In addition, to its function for ATP production D-ribose is a critical element of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and acetyl coenzyme A. Provided there is a reduction in ATP production; aging is frequently due to a decline in mitochondria function. Hence, cell function and integrity are compromised, leading to chronic cardiovascular conditions and fatigue (6). With active D-ribose supplementation, improvements have been noted in several pathological conditions such as chronic fatigue syndrome, fibromyalgia, and myocardial dysfunction. Furthermore, D-ribose demonstrated improvements in athletic performances by recovering ATP levels and repairing cellular damage.

Vitamin B3 is an essential water-soluble vitamin known as either niacin, nicotinic acid, or nicotinamide. It is found in foods such as chicken, beef, fish, nuts, legumes, and grains. Also, vitamin B3 can be obtained from conversions of tryptophan in the body. Therefore, foods with tryptophan such as milk, eggs, meat, and fish are another great source of vitamin B3. Once vitamin B3 is consumed, it is converted into two different active forms called NAD+ or nicotinamide adenine dinucleotide phosphate (NADP). NAD+ and NADP are essential for various metabolic redox processes with oxidized or reduced substrates. Cellular functions like genome integrity, gene expression, and cellular communication are carried out by NAD+ required enzymes. These required enzymes are also crucial for the production of ATP via energy transfer from carbohydrates, fats, and proteins. NADP is involved in fewer reactions than NAD+ such as cholesterol and fatty acid synthesis along with antioxidation. Lack of NAD+ has been associated with a variety of aging-related conditions such as metabolic syndrome, cardiovascular health, and cancer.

This current randomized, double-blind, comparator-controlled, cross over study will investigate the efficacy and safety of RiaGev™ via evaluation of NAD+, glucose, insulin, glutathione, and cortisol levels in healthy adults of ages 36-65.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized, double-blind, comparator-controlled, cross-over
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Other
Official Title: A Randomized, Double-blind, Comparator-controlled, Cross-over Study to Investigate the Safety and Efficacy of RiaGev™ in Healthy Adults
Actual Study Start Date : November 25, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RiaGev
RiaGev, 2000mg, BID
Dietary Supplement: RiaGev
Dietary supplementation

Active Comparator: Comparator
Comparator matched to RiaGev, BID
Dietary Supplement: RiaGev
Dietary supplementation




Primary Outcome Measures :
  1. Whole blood NAD+ level change from baseline [ Time Frame: Day 1 to 8 ]
    The change in whole blood NAD+ levels from baseline to day 8 when supplemented with RiaGev™ or comparator. The parameter is measured at Day 1, Day 3, Day 5, and Day 8.


Secondary Outcome Measures :
  1. Serum glucose change after RiaGev supplementation assessed by OGTT [ Time Frame: 7 days ]
    The change in serum glucose as assessed by an Oral Glucose Tolerance Test (OGTT) at t=0, 15m, 30, 45m, 60m, 90m and 2h after a 7-day supplementation with either RiaGev™ or comparator. The measure will take place on Day 1 and Day 8

  2. Serum insulin change after RiaGev supplementation assessed by OGTT [ Time Frame: 7 days ]
    The change in serum insulin as assessed by an Oral Glucose Tolerance Test (OGTT) at t=0, 15m, 30, 45m, 60m, 90m and 2h after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1 and Day 8.

  3. Serum Glutathione/Glutathione disulfide ratio change after RiaGev supplementation [ Time Frame: 7 days ]
    The change in serum Glutathione/Glutathione disulfide (GSH/GSSG) ratio after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1 and Day 8, before and after exercise.

  4. Serum ATP/AMP ratio change after RiaGev supplementation [ Time Frame: 7 days ]
    The change in serum adenosine triphosphate/ adenosine monophosphate (ATP/AMP) ratio after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1, Day 3, Day 5, and Day 8.

  5. The change in salivary cortisol after RiaGev supplementation [ Time Frame: 7 days ]
    The change in salivary cortisol after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1, 3, 5, and 8.

  6. The change in Checklist Individual Strength (CIS) Questionnaire outcome after a 7-day supplementation with either RiaGev™ or comparator. [ Time Frame: 7 days ]
    The change in Checklist Individual Strength (CIS) Questionnaire outcome after a 7-day supplementation with either RiaGev™ or comparator. There are twenty question categorized into four categories, including fatigue, concentration, motivation, and physical activity. The total as well as category score will be reported.


Other Outcome Measures:
  1. Incidence of pre-emergent and post-emergent adverse events when supplemented [ Time Frame: 7 days ]
    Incidence of pre-emergent and post-emergent adverse events when supplemented

  2. The number of out-of-norm clinical chemistry parameters when supplemented with Riagev comparing with comparator [ Time Frame: 7 days ]
    Clinical chemistry parameters including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, creatinine, electrolytes (Na, K, Cl), fasting glucose, and estimated glomerular filtration rate (eGFR). The number of out of norm incidence will be reported.

  3. The number of out of norm hematology parameters when supplemented with RiaGev comparing with comparator. [ Time Frame: 7 days ]
    Hematology parameters including white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), The number of out of norm incidence will be reported

  4. The number of out of norm vital signs including blood pressure (BP) and heart rate (HR) when supplemented [ Time Frame: 7 days ]
    Vital signs including blood pressure (BP) and heart rate (HR) are going to be measured. Out of norm incidence will be reported.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   36 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483011


Contacts
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Contact: Alex Xue, Ph.D 763-746-0032 ext 3924 alex.xue@bioenergyls.com

Locations
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United States, Minnesota
Prism Research, Inc. Recruiting
Saint Paul, Minnesota, United States, 55114
Contact: Jeff Cosgrove    651-641-2914    jcosgrove@prismresearchinc.com   
Contact: Trisha Shamp, PA-C, Ph.D    651-641-2917    tshamp@prismresearchinc.com   
Principal Investigator: Trisha Shamp, PA-C, Ph.D         
Sponsors and Collaborators
Bioenergy Life Science, Inc.
KGK Science Inc.
University of Washington
Investigators
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Study Chair: Malkanthi Evans, Ph.D KGK Science Inc.
Principal Investigator: Trisha Shamp, PA-C, Ph.D Prism Research, Inc.
  Study Documents (Full-Text)

Documents provided by Bioenergy Life Science, Inc.:
Statistical Analysis Plan  [PDF] June 24, 2020

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Responsible Party: Bioenergy Life Science, Inc.
ClinicalTrials.gov Identifier: NCT04483011    
Other Study ID Numbers: 19RNHB(1918)
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bioenergy Life Science, Inc.:
NAD+
ATP
Glutathione
Cortisol
Exercise
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Metabolic Syndrome
Syndrome
Aging, Premature
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases