Nicotinamide Riboside Clinical Trial for GWI

ConditionGulf War Illness

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age47-70

SponsorRoskamp Institute Inc.

About this trial

In this multi-site trial, we will use a randomized, double-blind, placebo-controlled study design to test whether 300 mg of Nicotinamide Riboside (NR) can achieve the primary objective of increasing plasma NAD+ levels in participants with Gulf War Illness (GWI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Both sexes, all ethnic groups, and ages 47 to 70 years.

Subject willing and able to give informed consent.

Medically stable as per the investigator's discretion.

Negative urine pregnancy test for females of childbearing potential. A woman is considered of childbearing potential unless she is surgically sterile (hysterectomy or tubal ligation) or is postmenopausal (no menstrual cycle for 2 years or more).

Disqualifiers

Diagnosed by a physician with medical or psychiatric conditions that would account for their symptoms or interfere with their ability to report their symptoms, as per investigator discretion.

Female subject is either pregnant or nursing; or if female subject is of childbearing age is not currently on or is unwilling and/or unable to use birth control.

Have contraindications, allergy, or sensitivity to NR, vitamin B3, or excipients (microcrystalline cellulose, silicon dioxide, magnesium stearate, hypromellose, and/or titanium dioxide).

Any significant medical condition that could interfere with study conduct, as per investigator discretion. These may include but are not limited to the following: untreated chronic hypertension (defined as systolic > 180 mmHg; diastolic >110 mmHg), myocardial infarction within 6 months of screening, renal failure, hepatic failure, and/or receiving chemotherapy.

Trial design

Design model

Parallel

Treatments tested in this trial

Nicotinamide Riboside
Dietary supplement
The product under investigation, Nicotinamide riboside (NR), is a naturally occurring NAD+ precursor and a member of the vitamin B3 family.
Placebo
Dietary supplement
Visually matching placebo capsules will contain the same inactive ingredients present in the manufactured NR capsules, with the exception of any NR compound.

Treatment groups

52 Participants

are divided into 2 treatment groups

Group A: Study Supplement: NRActive comparator 1 intervention

Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Changes in plasma NAD+ levels

The primary objective is to determine if NR can increase plasma NAD+ levels in GWI veterans.

Time frame

10 weeks

Secondary outcomes

Changes in lipid profiles

The secondary objective is to determine if NR can help maintain healthy blood lipid in the blood of veterans with GWI.

Time frame

10 weeks

Changes in immune biomarker profiles

The secondary objective is to determine if NR can help maintain normal cytokine levels in the blood of veterans with GWI.

Time frame

10 weeks

Other outcomes

Changes in fatigue

The study will use the Multidimensional Fatigue Inventory (MFI-20) to assess fatigue.

Time frame

10 weeks

Changes in memory (neurocognitive)

The study will use the CNS Vital Signs computerized neurocognitive assessment software to assess memory. The computerized test uses individual tests to comprise a neurocognitive index score that can be used to evaluate neurocognitive status.

Time frame

10 weeks

Changes in memory (neuropsychological)

The study will use the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) cognitive test to assess memory. The test incorporates immediate memory, visuospatial/constructional, language, attention, and delayed memory components to determine a total scaled score for neuropsychological status. This total score ranges from 200 to 800, with higher scores increasing the associated percentile.

Time frame

10 weeks

Changes in general well-being

The study will use the Quality of Life Scale (SF36) to assess quality of life.

Time frame

10 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roskamp Institute Inc.

Lead sponsor

United States Department of Defense

Collaborator

Nova Southeastern University

Collaborator

Source ClinicalTrials.gov

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