Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness

NCT07266571 | Not Yet Recruiting DMC

• 2 other identifiers: 30015456UAB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine how pycnogenol may reduce Gulf War Illness (GWI) symptom severity. The study will also examine the safety of this treatment and determine the optimal dosage. The investigators believe that GWI involves inflammation in the body and brain that causes fatigue, pain, cognitive disruption, and other symptoms. Botanicals that reduce inflammation may help treat GWI.

Conditions

Gulf War Syndrome

Keywords

Gulf War Illness; Pycnogenol; Botanical; French Maritime Pine Bark

Outcome Measures

Primary Outcomes (2)

• Change in Physical Functioning Score of the Veterans Rand 12-Item Health Survey

  This change will be measured using weekly surveys. Veterans Rand 12-Item Health Survey scores are standardized to a mean of 50 (SD = 10), with higher scores indicating better functioning; scores theoretically range from approximately 0 to 100.

  12 months

• Change in Mental Functioning Score of the Veterans Rand 12-Item Health Survey

  This change will be measured using weekly surveys. Veterans Rand 12-Item Health Survey scores are standardized to a mean of 50 (SD = 10), with higher scores indicating better functioning; scores theoretically range from approximately 0 to 100.

  12 months

Study Arms (1)

Participants Receiving Botanicals

EXPERIMENTAL

Participants Receiving Botanicals

Other: Placebo; Dietary Supplement: Pycnogenol, 100mg; Dietary Supplement: Pycnogenol, 200mg; Dietary Supplement: Pycnogenol, 400mg; Dietary Supplement: Pycnogenol, 600mg

Interventions

Placebo OTHER

The placebo being used in this study is microcrystalline cellulose. This will be taken orally, up to twice per day.

Also known as: Microcrystalline Cellulose

Participants Receiving Botanicals

Pycnogenol, 100mg DIETARY_SUPPLEMENT

Pycnogenol being used in this study is a commercially available dietary supplement and is classified as food by the FDA instead of a drug. This will be taken orally, up to twice per day.

Also known as: French Maritime Pine Bark

Participants Receiving Botanicals

Pycnogenol, 200mg DIETARY_SUPPLEMENT

Pycnogenol being used in this study is a commercially available dietary supplement and is classified as food by the FDA instead of a drug. This will be taken orally, up to twice per day.

Also known as: French Maritime Pine Bark

Participants Receiving Botanicals

Pycnogenol, 400mg DIETARY_SUPPLEMENT

Pycnogenol being used in this study is a commercially available dietary supplement and is classified as food by the FDA instead of a drug. This will be taken orally, up to twice per day.

Also known as: French Maritime Pine Bark

Participants Receiving Botanicals

Pycnogenol, 600mg DIETARY_SUPPLEMENT

Pycnogenol being used in this study is a commercially available dietary supplement and is classified as food by the FDA instead of a drug. This will be taken orally, up to twice per day.

Also known as: French Maritime Pine Bark

Participants Receiving Botanicals

Eligibility Criteria

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

You may qualify if:

• Meet the Kansas GWI case definition
• Meet the CDC GWI case definition
• Able to commit to a 12-month study
• Male
• Participants will be individuals in our Gulf War database who have already completed our other botanical trial, Curcumin, Resveratrol, and Stinging Nettle as Treatments for Gulf War Illness (NCT05377242).

You may not qualify if:

• Currently involved in another experimental treatment study
• Female
• Have a blood clotting disorder
• Reported diagnosis of diabetes with a A1C greater than 9
• Use of contraindicated medications (see below):
• Anticoagulants (such as warfarin, heparin, etc.)
• Lithium
• Tacrolimus (Prograf)
• Cancer medications (Alkylating agents, antitumor antibiotics, Topoisomerase I inhibitors, Tamoxifen)
• Daily Use of Antiplatelet agents (e.g. aspirin, clopidogrel)
• Nitroglycerin
• Hypotension
• Need for surgery during study period.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35243, United States

Location

MeSH Terms

Conditions

Persian Gulf Syndrome

Interventions

microcrystalline cellulose; pycnogenols

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries

Study Officials

• Jarred Younger, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarred Younger, PhD

CONTACT

205-975-5821; younger@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study is single-blind, participants will not know when they received placebo or pycnogenol. There are also four possible dosages for pycnogenol. Participants will also receive placebo (capsules with an inactive substance) at some point during the treatment phase of the study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)