NCT01699009

Brief Summary

The purpose of the study is to assess whether, in individuals with migraines, a low-fat, vegan diet improves pain more effectively than a control supplement or a placebo. The principal measures are pain as measured by Visual Analog Scale (VAS) and the change in migraines frequency. The study duration is 36 weeks.This study also tests that a low fat, plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 20, 2015

Status Verified

May 1, 2014

Enrollment Period

1.6 years

First QC Date

October 1, 2012

Last Update Submit

October 19, 2015

Conditions

Migraines

Keywords

Migraines, diet, vegan, vegetarian, plant-based

Outcome Measures

Primary Outcomes (4)

  • Migraines Pain Change in Migraines frequency

    Pain as measured by VAS score

    Baseline and 4 months

  • Change in Migraines frequency

    the reduction in the number of migraine attacks.

    Baseline and 4 months

  • Improvement in Mood

    mood changes will be measured using the Beck Depression Inventory II (BDI-II).

    Baseline and 4 months

  • Improvement in Mood

    Mood changes will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).

    Baseline and 4 months

Secondary Outcomes (1)

  • Quality of life

    Baseline and 4 months

Study Arms (2)

Vegan diet

EXPERIMENTAL

The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.

Other: Plant based diet

Supplement group

PLACEBO COMPARATOR

The supplement group will follow an unrestricted diet, but will be given a pill containing a small, clinically insignificant amount of omega- 3 oils and vitamin E, which will serve as a placebo.

Other: an unrestricted diet

Interventions

Plant based dietOTHER
Vegan diet
an unrestricted dietOTHER
Supplement group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of migraine, as defined by the criteria of the second edition of the International Classification of Headache Disorders:
  • At least 5 attacks fulfilling criteria the criteria below:
  • Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
  • Headache has at least two of the following characteristics:
  • unilateral location
  • pulsating quality
  • moderate or severe pain intensity
  • aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
  • During headache at least one of the following:
  • nausea and/or vomiting
  • photophobia and phonophobia Not attributed to another disorder
  • Migraines occurring at least twice per month, on average.
  • Age at least 18 years
  • Ability and willingness to participate in all components of the study
  • Willingness to be assigned to either the diet group or supplement group
  • +1 more criteria

You may not qualify if:

  • \< 18 years of age
  • Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
  • Pregnancy
  • Unstable medical or psychiatric illness
  • Likely to be disruptive in group sessions (as determined by research staff)
  • Already following a low-fat, vegan diet
  • Lack of English fluency
  • Inability to maintain current medication regimen
  • Inability or unwillingness to participate in all components of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (1)

  • Bunner AE, Agarwal U, Gonzales JF, Valente F, Barnard ND. Nutrition intervention for migraine: a randomized crossover trial. J Headache Pain. 2014 Oct 23;15(1):69. doi: 10.1186/1129-2377-15-69.

    PMID: 25339342DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Neal Barnard, MD

    Physicians Committee for Responsible Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 3, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 20, 2015

Record last verified: 2014-05

Locations

US(1)