The Safety and Efficacy Study of RiaGev in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT04483011|
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : July 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Chronic Fatigue Syndrome Premature Aging||Dietary Supplement: RiaGev||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||randomized, double-blind, comparator-controlled, cross-over|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
RiaGev, 2000mg, BID
Dietary Supplement: RiaGev
Active Comparator: Comparator
Comparator matched to RiaGev, BID
Dietary Supplement: RiaGev
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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
- 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.
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
|Contact: Alex Xue, Ph.D||763-746-0032 ext firstname.lastname@example.org|
|United States, Minnesota|
|Prism Research, Inc.||Recruiting|
|Saint Paul, Minnesota, United States, 55114|
|Contact: Jeff Cosgrove 651-641-2914 email@example.com|
|Contact: Trisha Shamp, PA-C, Ph.D 651-641-2917 firstname.lastname@example.org|
|Principal Investigator: Trisha Shamp, PA-C, Ph.D|
|Study Chair:||Malkanthi Evans, Ph.D||KGK Science Inc.|
|Principal Investigator:||Trisha Shamp, PA-C, Ph.D||Prism Research, Inc.|