Recruiting
Phase 2

Nutrition

Sponsor:

Uniformed Services University of the Health Sciences

Code:

NCT03272399

Conditions

Post-Traumatic Headache Chronic Without Intractable Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diet/nutrition intervention

Study Details

Brief summary:

The purpose of this multi-site study is to evaluate the efficacy of a high omega-3/low omega-6 dietary intervention (the H3-L6 Diet) vs. a Control Diet in reducing headache pain and improving function in soldiers, veterans and military healthcare beneficiaries with post-traumatic headache (PTH). In addition, the study will examine the effects of the diet interventions on anti-nociceptive and pro-nociceptive lipid mediators derived from omega-3 and omega-6 fatty acids.

Conditions

Post-Traumatic Headache Chronic Without Intractable Headache

Study ID

NCT03272399

Start date

Aug 21, 2017

Status verified date

Oct, 2021

Completion date

Mar 31, 2022

Anticipated

Primary completion date

Mar 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • In order to be included in the study, you must be a person of either gender who is at least 18 years of age, meets criteria of having had a traumatic brain injury, a physiological disruption of brain function, as manifested by at least one of the following:

1. . Any period of loss of consciousness
2. . Any loss of memory for events immediately before or after the accident
3. . Any alteration of mental state at the time of the accident (e.g., feeling dazed, disoriented, and confused)
4. . Focal neurologic deficits that may or may not be permanent.

  • Traumatically induced includes the head being struck, the head striking an object, or the brain undergoing an acceleration/deceleration movement (i.e. whiplash) without direct external trauma to the head.
  • Meets Internation Classification of Headache Disorders-version III (ICHD-III) criteria for persistent post-traumatic headache which is defined as a headache of at least 3 months duration caused by a traumatic injury to the head.
  • Meets ICHD-III criteria for episodic/chronic migraine, with or without aura (excepting exclusion for organic disease):

1. . Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
2. . Headache has at least 2 of the following characteristics:

1. unilateral location
2. pulsating quality
3. moderate or severe pain intensity
4. aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
3. . During headache at least 1 of the following:

1. nausea and/or vomiting
2. photophobia and phonophobia
  • A potential candidate for this study must be under the care of a physician for headaches and have an incomplete response to standard headache treatments.
  • Must have headache frequency of more than 8 days per month.
  • Must have a headache history of more than 6 months
  • Must be able to attend or remotely participate (by video conference or telephone) in seven dietitian counseling sessions, and adhere to diet supplied to study participants.
  • Must be a Department of Defense (DoD) healthcare beneficiary and eligible to receive care at Walter Reed National Military Medical Center (WRNMMC), Fort Belvoir Community Hospital (FBCH) or Womack Army Medical Center (WAMC).

Exclusion Criteria:

  • A person cannot be in this study if they have a history of specific food allergies, especially to fish, dairy or gluten.

Also exclusionary are:

  • Pregnancy or anticipated pregnancy
  • Aversion to eating fish
  • History of organic brain disorder other than TBI (vasculitis, encephalitis, meningitis, brain tumor)
  • Major medical illness such as malignancy, diabetes, autoimmune or immune deficiency disorders, history of stroke or myocardial infarction
  • Anticipated deployment or move to alternate location in the next 16 weeks
  • Inability to read and communicate in English
  • Regular use of fatty acid containing supplements
  • Active or recent (2 years) history of treatment for substance abuse
  • Cognitive impairment that prevents understanding of the protocol and completion of study procedures including compliance with the diet, blood draws and maintaining a daily headache diary.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: H3-L6

High Omega-3, low Omega-6 diet

active comparator: L3-H6

Control diet containing average US polyunsaturated fatty acid (PUFA) content with low omega-3 and high omega-6 content

Interventions

Diet/nutrition intervention

The intervention will be administered through food products rather than dietary supplements

Primary outcome measure

  • Primary Clinical Outcome: To compare the efficacy of the high omega-3/low omega-6 (H3-L6) diet to the low omega-3/high omega-6 (L3-H6) diet in reducing headache pain and improving headache-related quality of life. [ Time Frame: The HIT-6 is administered at study visits at week 0 (enrollment), 4, 10, 12, 14, 16 ]
  • Primary Biochemical Outcome: To evaluate the effects of the H3-L6 and L3-H6 Diet on circulating fatty acids and bioactive metabolites. [ Time Frame: Fasting blood draws at study visits at weeks 4, 10, 16 ]

Central Contacts and Locations

Central contacts

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Womack Army Medical Center (WAMC)

Recruiting

Fort Bragg, North Carolina, United States, 28310

Contacts

Fort Belvoir Community Hospital

Recruiting

Fort Belvoir, Virginia, United States, 22060

Contacts

More Information

Sponsor

Uniformed Services University of the Health Sciences

Last update posted

Oct 5, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Uniformed Services University of the Health Sciences on 2021-10-05.