The Safety and Efficacy Study of RiaGev in Healthy Adults

Metabolic Syndrome Clinical Trial

Official title: A Randomized, Double-blind, Comparator-controlled, Cross-over Study to Investigate the Safety and Efficacy of RiaGev™ in Healthy Adults

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Aging, Premature
• Metabolic Syndrome
• Premature Aging

• NCT number: NCT04483011
• Study type: Interventional
• Source: Bioenergy Life Science, Inc.
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 25, 2019
• Completion date: November 30, 2020