Evidence map›Paper›PMID 39380085›Full record

ArticleTrials2024

Investigating the effects of co-supplementation with alpha-linolenic acid and L-carnitine on inflammatory status, oxidative stress, clinical symptoms, mental health and quality of life in women with migraine: a protocol for a randomized, triple-blind, placebo-controlled trial.

Sahar Golpour-Hamedani, Mohammad Bagherniy, Fariborz Khorvash, Awat Feizi, Manoj Sharma, Gholamreza Askari

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Sahar Golpour-HamedaniNutrition and Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Mohammad BagherniyNutrition and Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Fariborz KhorvashDepartment of Neurology, Isfahan University of Medical Sciences, Isfahan, Iran.
Awat FeiziDepartment of Epidemiology and Biostatistics, School of Health and Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
Manoj SharmaDepartment of Social and Behavioral Health, School of Public Health, University of Nevada, Las Vegas, NV, USA.
Gholamreza AskariNutrition and Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Askari@mui.ac.ir.ORCID http://orcid.org/0000-0003-1194-9687

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMigraine is a severe neurological disorder that is recognized as one of the most common debilitating diseases worldwide. Although the exact cause of migraine is not known, research suggests that inflammation, oxidative stress, mitochondrial dysfunction, and insufficient nutrients may contribute to its development. Studies indicate that nutrition-based approaches are safer and more cost-effective strategies for managing migraine symptoms compared to medication. In this regard, the impact of nutrition, as a complementary medicine, is largely attributed to that of certain nutrients on inflammation and mitochondrial function. It is hypothesized that alpha-linolenic acid and L-carnitine, which possess anti-inflammatory and antioxidant properties, may be synergically beneficial for migraine patients. Therefore, this study will be conducted to assess the efficacy of alpha-linolenic acid and L-carnitine co-supplementation in patients with migraine.

methodsThis is a parallel, randomized, triple-blind, placebo-controlled clinical trial, in which 80 women aged 20 to 50 years with migraine will be assigned to receive either intervention group (n = 40) receiving both 1000 mg/day flaxseed oil and 500 mg/day L-carnitine simultaneously for 12 weeks, or control group (n = 40) receiving both 1000 mg/day paraffin oil and 500 mg/day maltodextrin as the placebos for the same duration. The primary outcomes include changes in clinical symptoms of migraine, including frequency, severity, and duration of attacks, serum levels of C-reactive protein (CRP), total antioxidant capacity (TAC), nitric oxide (NO), malondialdehyde (MDA), and superoxide dismutase (SOD). Secondary outcomes include mental health, sleep quality, and quality of life (QOL). DISCUSSION: In this study, we aim to investigate the potential benefits of combining alpha-linolenic acid and L-carnitine as a treatment option for migraine sufferers. Migraine, characterized by recurrent severe headaches, affects a significant portion of the population and can significantly impact an individual's quality of life. By studying alternative therapies such as alpha-linolenic acid and L-carnitine, researchers hope to expand the range of treatment options available and potentially provide relief to migraine sufferers.

trial registrationIranian Registry of Clinical Trials ( www.irct.ir ) (ID: IRCT20121216011763N57). Registration date: 29 March 2023. TRIAL STATUS: The protocol is version 1.0 dated December 30, 2023. Recruitment began on July 10, 2023, and is expected to be completed by January 22, 2024.

Indexed as

alpha-Linolenic AcidCarnitineDietary SupplementsMental HealthMigraine DisordersOxidative StressQuality of LifeAdultAnti-Inflammatory AgentsAntioxidantsBiomarkersFemaleHumansInflammationInflammation MediatorsIranalpha-Linolenic AcidAnti-Inflammatory AgentsAntioxidantsBiomarkersCarnitineInflammation MediatorsLinseed OilAlpha-linolenic acidInflammationL-carnitineMigraineOxidative stress

Identifiers

PMID39380085
PMCPMC11463146

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.