Curcumin, Resveratrol, and Stinging Nettle as Treatments for GWI

NCT05377242 | Active Not Recruiting

• 2 other identifiers: GW210009W81XWH-22-1-0420
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

This project's objective is to identify effective treatments for Gulf War Illness (GWI). The project tests three potential treatments: curcumin, stinging nettle, and resveratrol. The project uses a decentralized clinical trial (DCT) design in which individuals can participate from anywhere in the United States. Recruitment efforts will be designed to obtain a geographically and demographically diverse study sample.

Conditions

Gulf War Illness

Keywords

Gulf War Illness; Botanicals; Remote; Clinical Trial; Curcumin; Resveratrol; Stinging Nettle

Outcome Measures

Primary Outcomes (2)

• Average Veterans Rand 12-Item Health Survey (VR-12) Physical Functioning Score

  Veterans Rand 12-Item Health Survey (VR-12) Physical Functioning Score (PFS) will be assessed via an online survey. The PFS will be assessed on a 7-32 point scale, with higher scores indicating better health.

  This outcome will be assessed weekly, for up to 44 weeks.

• Average Veterans Rand 12-Item Health Survey (VR-12) Mental Functioning Score

  Veterans Rand 12-Item Health Survey (VR-12) Mental Functioning Score (MFS) will be assessed via an online survey. The MFS will be assessed on a 6-33 point scale, with higher scores indicating better health.

  This outcome will be assessed weekly, for up to 44 weeks.

Secondary Outcomes (2)

• Patient Global Impression of Change (PGIC)

  This outcome will be assessed weekly, for up to 44 weeks.

• Number needed to treat (NNT)

  This outcome will be assessed once, through study completion, an average of 44 weeks.

Other Outcomes (1)

• Weekly Symptom Reports

  This outcome will be assessed weekly, for up to 44 weeks.

Study Arms (3)

Gulf War Veterans, Curcumin

EXPERIMENTAL

All GWI Veterans will undergo the same screening and experimental procedures. Participants must meet both the Kansas and CDC (Centers for Disease Control and Prevention) Case Definitions of GWI. Participants must have been deployed to the Persian Gulf Region during the 1990-1991 Gulf War, meet symptom domain criteria, and not have exclusionary medical conditions. This trial tests three interventions, which are all tested independently. Participants will receive only one of the three interventions. The curcumin, resveratrol, and stinging nettle trials all follow the same design and procedures. Participants will complete one month of baseline, eight months of capsules, and one month of endline measurements.

Dietary Supplement: Curcumin

Gulf War Veterans, Resveratrol

EXPERIMENTAL

All GWI Veterans will undergo the same screening and experimental procedures. Participants must meet both the Kansas and CDC (Centers for Disease Control and Prevention) Case Definitions of GWI. Participants must have been deployed to the Persian Gulf Region during the 1990-1991 Gulf War, meet symptom domain criteria, and not have exclusionary medical conditions. This trial tests three interventions, which are all tested independently. Participants will receive only one of the three interventions. The curcumin, resveratrol, and stinging nettle trials all follow the same design and procedures. Participants will complete one month of baseline, eight months of capsules, and one month of endline measurements.

Dietary Supplement: Resveratrol

Gulf War Veterans, Stinging Nettle

EXPERIMENTAL

All GWI Veterans will undergo the same screening and experimental procedures. Participants must meet both the Kansas and CDC (Centers for Disease Control and Prevention) Case Definitions of GWI. Participants must have been deployed to the Persian Gulf Region during the 1990-1991 Gulf War, meet symptom domain criteria, and not have exclusionary medical conditions. This trial tests three interventions, which are all tested independently. Participants will receive only one of the three interventions. The curcumin, resveratrol, and stinging nettle trials all follow the same design and procedures. Participants will complete one month of baseline, eight months of capsules, and one month of endline measurements.

Dietary Supplement: Stinging Nettle

Interventions

Curcumin DIETARY_SUPPLEMENT

Curcumin (chemical C21H20O6) is derived from turmeric (Curcuma longa) root extract, standardized to contain 95% curcuminoids. The greatest obstacle with curcumin is its poor natural bioavailability. To help circumvent that issue, a piperazine is included as black pepper 5.3mg (Piper nigrum) fruit extract standardized to 95% piperine. The botanical we are using is provided by Pure Encapsulations. Curcumin being used in this study is a commercially available dietary supplement and is classified as food by the FDA instead of a drug. 100 participants will be randomized to receive curcumin. Participants will receive placebo, low-dose (500 mg/day), medium-dose (1000 mg/day), and/or high dose (2000 mg/day) curcumin in a randomized order.

Gulf War Veterans, Curcumin

Resveratrol DIETARY_SUPPLEMENT

Resveratrol (chemical C14H12O3) is provided as 99% Pure Trans-Resveratrol (MegaResveratrol) from polygonum cuspidatum root). Resveratrol being used in this study is a commercially available dietary supplement and is classified as food by the FDA instead of a drug. 100 participants will be randomized to receive resveratrol. Participants will receive placebo, low-dose (250 mg/day), medium-dose (500mg/day), and/or high dose (1000mg/day) resveratrol in a randomized order.

Gulf War Veterans, Resveratrol

Stinging Nettle DIETARY_SUPPLEMENT

Stinging nettle is derived from nettle (Urtica spp) leaf. The botanical we are using is provided by Pure Encapsulations. Stinging Nettle being used in this study is a commercially available dietary supplement and is classified as food by the FDA instead of a drug. 100 participants will be randomized to receive stinging nettle. Participants will receive placebo, low-dose (435mg/day), medium-dose (870mg/day), and/or high dose (2610mg/day) stinging nettle in a randomized order.

Also known as: Urtica dioica

Gulf War Veterans, Stinging Nettle

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets Kansas GWI Case Definition
• Meets CDC GWI Case Definition
• Able to commit to a 10-month study

You may not qualify if:

• Currently involved in an experimental treatment study
• Abnormal liver function values
• Abnormal kidney function values
• Currently pregnant
• Blood clotting disorder (contraindicated with all three botanicals)
• Reported diagnosis of diabetes with an A1C greater than 9
• The use of contraindicated medications (see below):
• Anticoagulant medications (such as warfarin, heparin, etc.)
• Lithium
• Tacrolimus (Prograf)
• Cancer medications (Alkylating agents, antitumor antibiotics, Topoisomerase I inhibitors, Tamoxifen)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (3)

• Donovan EK, Kekes-Szabo S, Lin JC, Massey RL, Cobb JD, Hodgin KS, Ness TJ, Hangee-Bauer C, Younger JW. A Placebo-Controlled, Pseudo-Randomized, Crossover Trial of Botanical Agents for Gulf War Illness: Curcumin (Curcuma longa), Boswellia (Boswellia serrata), and French Maritime Pine Bark (Pinus pinaster). Int J Environ Res Public Health. 2021 Mar 3;18(5):2468. doi: 10.3390/ijerph18052468.

  PMID: 33802272 BACKGROUND

• Hodgin KS, Donovan EK, Kekes-Szabo S, Lin JC, Feick J, Massey RL, Ness TJ, Younger JW. A Placebo-Controlled, Pseudo-Randomized, Crossover Trial of Botanical Agents for Gulf War Illness: Resveratrol (Polygonum cuspidatum), Luteolin, and Fisetin (Rhus succedanea). Int J Environ Res Public Health. 2021 Mar 3;18(5):2483. doi: 10.3390/ijerph18052483.

  PMID: 33802381 BACKGROUND

• Younger J, Donovan EK, Hodgin KS, Ness TJ. A Placebo-Controlled, Pseudo-Randomized, Crossover Trial of Botanical Agents for Gulf War Illness: Reishi Mushroom (Ganoderma lucidum), Stinging Nettle (Urtica dioica), and Epimedium (Epimedium sagittatum). Int J Environ Res Public Health. 2021 Apr 1;18(7):3671. doi: 10.3390/ijerph18073671.

  PMID: 33915962 BACKGROUND

MeSH Terms

Interventions

Curcumin; Resveratrol; stinging nettle lectin

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Stilbestrols; Stilbenes; Benzylidene Compounds; Polyphenols

Study Officials

• Jarred Younger, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, the study PI, and the main research team will be blinded.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study uses a prospective, pseudo-randomized, placebo-controlled, blinded, within-person clinical trial design. Individuals will be randomized in a double-blind fashion to either the curcumin, resveratrol, or stinging nettle treatment.

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 17, 2022
• Study Start: May 31, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)