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

April 17, 2026 updated by: Jarred Younger, University of Alabama at Birmingham
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study uses a decentralized design where individuals can participate from anywhere in the Alabama. Botanicals will be received by mail. Participants will also receive placebo (capsules with an inactive substance) during the treatment phase of the study. All participants will have been present in the Persian Gulf between 1990 and August 1991. This study will be tested on GWI participants recruited in Alabama, with a total of up to 20 participants enrolled (to account for potential withdrawals to obtain 10 completed participants) for the entire study. Participation will last 12 months.

The first stage of the study is the baseline phase. During this time, participants will complete weekly questionnaires about symptom severity ratings but will not take any capsules. The baseline stage will last for 30 days.

After the 30-day baseline, the treatment stage will begin. Capsules will be taken once in the morning, and once before bed. This study is single-blind, meaning that participants will not know when placebo or pycnogenol are received. There are also four possible dosages for pycnogenol.

The capsules will be packaged to indicate the order in which they should be taken. The capsules will be packaged in blister packs and shipped to participants. The capsules are designed to look the same throughout the study, though the contents can change. This treatment stage is the longest, lasting 10 months.

During the treatment stage, participants will also be asked to complete weekly questionnaires about GWI symptoms. These weekly questionnaires will also ask about changes in symptoms and overall quality of life, as well as changes in physical and mental health. Questionnaires can be completed on a smartphone, computer, or tablet. If participants do not have an appropriate device, or do not want to use a personal device, a tablet can be sent for the study. A research team member will speak with participants to set up electronic device connections and will verify the information is received.

At the end of the treatment stage, participants will stop taking capsules and will complete the end line stage. This stage is the same as the baseline stage in which participants will complete weekly symptom measures without taking capsules. This stage will last for 30 days.

After completion of the study, participants will be told when placebo was received, and what dosage(s) of treatment were received. Participants will also be shown how GWI severity changes over time.

While this study is long, it is designed to not be a significant burden to daily life. On most days, participation (taking morning capsules, taking evening capsules, and completing weekly symptom severity reports) should take approximately 2 minutes.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jarred Younger, PhD
  • Phone Number: 205-975-5821
  • Email: younger@uab.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Jarred Younger, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants Receiving Botanicals
Other: Placebo
The placebo being used in this study is microcrystalline cellulose. This will be taken orally, up to twice per day.
Other Names:
  • Microcrystalline Cellulose
Dietary supplement: Pycnogenol, 100mg
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.
Other Names:
  • French Maritime Pine Bark
Dietary supplement: Pycnogenol, 200mg
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.
Other Names:
  • French Maritime Pine Bark
Dietary supplement: Pycnogenol, 400mg
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.
Other Names:
  • French Maritime Pine Bark
Dietary supplement: Pycnogenol, 600mg
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.
Other Names:
  • French Maritime Pine Bark

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Functioning Score of the Veterans Rand 12-Item Health Survey
Time Frame: 12 months
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
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Jarred Younger, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30015456
  • UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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