NCT04483011 is a NA clinical trial of RiaGev in Metabolic Syndrome, sponsored by Bioenergy Life Science, Inc..

Who is sponsoring NCT04483011?

NCT04483011 is sponsored by Bioenergy Life Science, Inc..

What drugs are being tested in NCT04483011?

Interventions in NCT04483011: RiaGev.

What condition does NCT04483011 study?

NCT04483011 studies Metabolic Syndrome, Premature Aging.

Is NCT04483011 still recruiting?

NCT04483011 is currently status unknown. Last updated 25 November 2020.

Are results published for NCT04483011?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-11-25 · How we verify

NCT04483011

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Safety and Efficacy Study of RiaGev in Healthy Adults

Status unknown NA Results posted Last updated 25 November 2020

What this trial tests

NA trial testing RiaGev in Metabolic Syndrome in 18 participants. Status unknown.

Timeline

25 October 2019

Primary endpoint
30 July 2020

30 November 2020

Quick facts

Lead sponsor	Bioenergy Life Science, Inc.
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	other
Enrollment	18
Start date	25 October 2019
Primary completion	30 July 2020
Estimated completion	30 November 2020
Sites	1 location across United States

Drugs / interventions tested

RiaGev

Conditions studied

Metabolic Syndrome — all drugs for Metabolic Syndrome →
Premature Aging — all drugs for Premature Aging →

Sponsor

Bioenergy Life Science, Inc.

Who can join

Adults 36 to 65, any sex, with Metabolic Syndrome or Premature Aging. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Whole Blood NAD+ Level Change Over Baseline After Supplementation Primary · Day 1 to Day 8

Whole blood NAD+ concentration are measured at Day 1, Day 3, Day 5, and Day 8. A NAD+ Level change over baseline (Day 1) is calculated by subtracting the NAD+ level at Day 1 ( e.g Day 5 over Day 1 = Day 5 - Day 1). The significance of change (p value) is calculated comparing within RiaGev or Comparator group, and between RiaGev and Comparator groups.

Day 3 over Day 1

Group	Value	95% CI
RiaGev	1.23	± 3.39
Comparator	0.13	± 4.83

Day 5 over Day 1

Group	Value	95% CI
RiaGev	2.12	± 4.72
Comparator	-0.20	± 2.79

Day 8 over Day 1

Group	Value	95% CI
RiaGev	1.30	± 3.20
Comparator	-0.60	± 2.53

Whole Blood NADP+ Level Change Over Baseline After Supplementation Primary · Day 1 to Day 8

Whole blood NADP+ concentration are measured at Day 1, Day 3, Day 5, and Day 8. NADP+ level changes over baseline (Day 1) are calculated by substracting NADP+ level at Day 1. The significance of change (p values) are calculated comparing changes within and between RiaGev and Comparator groups.

Day 3 over Day 1

Group	Value	95% CI
RiaGev	1.30	± 1.72
Comparator	0.85	± 2.49

Day 5 over Day 1

Group	Value	95% CI
RiaGev	1.88	± 2.55
Comparator	0.51	± 1.52

Day 8 over Day 1

Group	Value	95% CI
RiaGev	1.33	± 1.88
Comparator	0.34	± 1.34

Whole Blood NAD+ Plus NADP+ Level Change Over Baseline Primary · Day 1 to 8

The change in whole blood NAD+ plus NADP+ levels from Day 1 baseline to Day 8 when supplemented with RiaGev™ or comparator. The parameter is measured at Day 1, Day 3, Day 5, and Day 8. A change over baseline is calculated by subtracting Day 1 value. The significance of changes (p value) are calculated by comparing within and between RiaGev and Comparator groups.

Day 3 over Day 1

Group	Value	95% CI
RiaGev	2.54	± 4.60
Comparator	0.97	± 7.10

Day 5 over Day 1

Group	Value	95% CI
RiaGev	4.01	± 6.57
Comparator	0.40	± 3.88

Day 8 over Day 1

Group	Value	95% CI
RiaGev	2.63	± 4.30
Comparator	-0.24	± 3.39

Serum Glucose Change After RiaGev Supplementation Assessed by OGTT Secondary · 7 days

The serum glucose as assessed by a standard Oral Glucose Tolerance Test (OGTT) on Day 1 and on Day 8 after 7-day supplementation with either RiaGev™ or comparator. Incremental Area Under the Curve (iAUC) is used as overall blood glucose. Serum glucose change is calculated by subtracting iAUC on Day 1 from iAUC on Day 8. The significance of change (p value) is calculated by comparing values on Day 8 and Day 1.

Day 1

Group	Value	95% CI
RiaGev	17700.42	± 2525.30
Comparator	876.25	± 1601.18

Day 8

Group	Value	95% CI
RiaGev	662.50	± 2031.70
Comparator	574.17	± 1640.77

Change from Day 1 to Day 8

Group	Value	95% CI
RiaGev	-1037.92	± 1590.74
Comparator	-302.08	± 1427.42

Serum Insulin Change After RiaGev Supplementation Assessed by OGTT Secondary · 7 days

Serum insulin is assessed by a standard Oral Glucose Tolerance Test (OGTT) on Day 1 and Day 8 after 7-day supplementation with either RiaGev™ or comparator. Serum insulin change is calculated by substracting its level on Day 1 from Day 8. The significance of change (p value) is calculated by comparing Day 1 and Day 8.

Day 1

Group	Value	95% CI
RiaGev	4807.42	± 2419.04
Comparator	4545.67	± 1915.67

Day 8

Group	Value	95% CI
RiaGev	4672.29	± 2427.27
Comparator	4410.88	± 1929.12

Change from Day 1 to Day 8

Group	Value	95% CI
RiaGev	-135.13	± 2153.66
Comparator	-134.79	± 1830.16

Serum Glutathione (GSH + GSSG) Change Over Baseline After RiaGev Supplementation Secondary · 7 days

Total serum Glutathione (GSH + GSSG) is measured on Day 1, Day 3, Day 5 and Day 8. after a 7-day supplementation with either RiaGev™ or comparator. A change over baseline is calculated by subtracting glutathione level on Day 1 baseline (e g Day 5 over Day 1 = Day 5 - Day 1). The significance of change (p value) is calculated within the RiaGev or Comparator group.

Day 3 over Day 1

Group	Value	95% CI
RiaGev	61.85	± 124.73
Comparator	32.43	± 130.37

Day 5 over Day 1

Group	Value	95% CI
RiaGev	70.20	± 123.89
Comparator	15.55	± 88.62

Day 8 over Day 1

Group	Value	95% CI
RiaGev	9.55	± 66.82
Comparator	-15.08	± 76.05

Serum High Energy Phosphate (ATP + ADP) Concentration After RiaGev Supplementation Secondary · 7 days

Serum high energy phosphate (ATP + ADP) after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1, Day 3, Day 5, and Day 8. Comparison are made between the two groups. The significance (p value) is also calculated between the groups.

Day 1 (baseline)

Group	Value	95% CI
RiaGev	327.10	± 42.87
Comparator	324.94	± 58.55

Day 3

Group	Value	95% CI
RiaGev	351.18	± 75.71
Comparator	345.98	± 102.56

Day 5

Group	Value	95% CI
RiaGev	353.28	± 82.03
Comparator	329.27	± 94.34

Day 8

Group	Value	95% CI
RiaGev	330.40	± 41.89
Comparator	326.20	± 45.46

The Waking Salivary Cortisol Level After RiaGev Supplementation Secondary · 7 days

The salivary cortisol level after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1, 3, 5, and 8. The salivary cortisol level as well as change of salivary cortisol level over baseline (Day 1) are reported. Comparisons are make both between the RiaGev and Comparison groups as well as within RiaGev group against its Day 1 baseline. The corresponding significance (p value) will be calculated.

Day 1 (baseline)

Group	Value	95% CI
RiaGev	0.43	± 0.15
Comparator	0.51	± 0.24

Day 3

Group	Value	95% CI
RiaGev	0.40	± 0.19
Comparator	0.47	± 0.19

Day 5

Group	Value	95% CI
RiaGev	0.41	± 0.32
Comparator	0.57	± 0.29

Day 8

Group	Value	95% CI
RiaGev	0.38	± 0.18
Comparator	0.51	± 0.22

Day 3 over Day 1

Group	Value	95% CI
RiaGev	-0.03	± 0.18
Comparator	-0.04	± 0.26

Day 5 over Day 1

Group	Value	95% CI
RiaGev	-0.02	± 0.34
Comparator	0.07	± 0.36

Day 8 over Day 1

Group	Value	95% CI
RiaGev	-0.05	± 0.19
Comparator	0.00	± 0.28

The Change in Checklist Individual Strength (CIS) Questionnaire Outcome After a 7-day Supplementation With Either RiaGev™ or Comparator. Secondary · 7 days

Checklist Individual Strength (CIS) Questionnaire was designed by the Dutch research team of Vercoulen et el, to measure fatigues. A standard CIS Questionnaire contains 20 questions, each scoring 1 to 7, total score 20 - 140, with higher score indicating more tiredness. Thus, a negative value in changing score (such as Day 5 - Day 1 baseline) means reduction of tiredness and verse versa.

Day 3 over Day 1

Group	Value	95% CI
RiaGev	-9.78	± 13.45
Comparator	-4.28	± 5.93

Day 5 over Day 1

Group	Value	95% CI
RiaGev	-8.33	± 12.99
Comparator	-2.56	± 5.66

Day 8 over Day 1

Group	Value	95% CI
RiaGev	-5.78	± 16.27
Comparator	-1.67	± 7.54

The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator Secondary · 7 days

The number of out-of-norm incidence (as indicator of safety) will be reported. Clinical chemistry parameters including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, creatinine, electrolytes (Na, K, Cl), fasting glucose. When a parameter is within normal limit, it will been reported as 0 out-of-norm.

Creatine Clearance

Group	Value	95% CI
RiaGev	0
Comparator	0

Creatinine

Group	Value	95% CI
RiaGev	0
Comparator	0

Fasting Blood Glucose

Group	Value	95% CI
RiaGev	0
Comparator	0

Aspartate Transaminase (AST)

Group	Value	95% CI
RiaGev	0
Comparator	0

Alanine Transaminase (ALT)

Group	Value	95% CI
RiaGev	0
Comparator	0

Chloride

Group	Value	95% CI
RiaGev	0
Comparator	0

Potassium

Group	Value	95% CI
RiaGev	0
Comparator	0

Sodium

Group	Value	95% CI
RiaGev	0
Comparator	0

The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator. Secondary · 7 days

The number of out-of-norm hematology parameter incidence (as indicator of safety) will be reported. Hematology parameters include 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). When a parameter is within normal limits, it is reported as 0 out-of-norm.

White Blood Cell Counts

Group	Value	95% CI
RiaGev	0
Comparator	0

Red Blood Cell Counts

Group	Value	95% CI
RiaGev	0
Comparator	0

Hemoglobin

Group	Value	95% CI
RiaGev	0
Comparator	0

Hemotocrit

Group	Value	95% CI
RiaGev	0
Comparator	0

Mean Corpuscular Volume

Group	Value	95% CI
RiaGev	0
Comparator	0

Mean Corpuscular Hemoglobin

Group	Value	95% CI
RiaGev	0
Comparator	0

Mean Corpuscular Hemoglobin Concentration

Group	Value	95% CI
RiaGev	0
Comparator	0

Red Blood Cell Distribution Width

Group	Value	95% CI
RiaGev	0
Comparator	0

The Number of Out-of-norm Vital Signs When Supplemented With RiaGev or Comparator Secondary · 7 days

Vital signs include blood pressure (BP) and heart rate (HR). The number of out-of-norm incidence will be reported. When a parameter is within normal limits, it is reported as 0 out-of-norm.

Systolic Pressure

Group	Value	95% CI
RiaGev	0
Comparator	0

Diastolic Pressure

Group	Value	95% CI
RiaGev	0
Comparator	0

Heart Rate

Group	Value	95% CI
RiaGev	0
Comparator	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 22 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RiaGev

Serious: 0/18 (0%)

Deaths: 0/18

Comparator

Serious: 0/17 (0%)

Deaths: 0/17

Other adverse events (3 terms — click to expand)

Reaction	System	RiaGev	Comparator
Asthenia	General disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT04483011 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Nicotinamide phosphoribosyltransferase in NAD<sup>+</sup> metabolism: physiological and pathophysiological implications.
Zhang W, Ren H, Chen W, Hu B, et al · · 2025 · cited 12× · PMID 40775221 · DOI 10.1038/s41420-025-02672-w
A Combination of Nicotinamide and D-Ribose (RiaGev) Is Safe and Effective to Increase NAD<sup>+</sup> Metabolome in Healthy Middle-Aged Adults: A Randomized, Triple-Blind, Placebo-Controlled, Cross-Over Pilot Clinical Trial.
Xue Y, Shamp T, Nagana Gowda GA, Crabtree M, et al · · 2022 · cited 12× · PMID 35684021 · DOI 10.3390/nu14112219

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04483011 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bioenergy Life Science, Inc.
Last refreshed: 25 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04483011.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04483011

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Metabolic Syndrome

Verify against primary sources