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.

2024-10-08
Trials 25(1)
- Sahar Golpour-Hamedani
- Mohammad Bagherniy
- Fariborz Khorvash
- Awat Feizi
- Manoj Sharma
- Gholamreza Askari

PubMed: 39380085
DOI: 10.1186/s13063-024-08500-3

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 80
Population: 80 women aged 20 to 50 years with migraine
Methods: parallel, randomized, triple-blind, placebo-controlled clinical trial; intervention group receives 1000 mg/day flaxseed oil and 500 mg/day L-carnitine simultaneously for 12 weeks; control group receives 1000 mg/day paraffin oil and 500 mg/day maltodextrin as placebos for the same duration
Blinding: Triple-blind
Duration: 12 weeks

Background

Migraine 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.

Methods

This 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 registration

Iranian 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.

Research Insights

L-Carnitine→Improved Mental Health
Secondary outcomes include mental health, sleep quality, and quality of life (QOL)
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day
L-Carnitine→Improved Quality of Life
Secondary outcomes include mental health, sleep quality, and quality of life (QOL)
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day
L-Carnitine→Improved Sleep Quality
Secondary outcomes include mental health, sleep quality, and quality of life (QOL)
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day
L-Carnitine→Improved Superoxide Dismutase Level
serum levels of C-reactive protein (CRP), total antioxidant capacity (TAC), nitric oxide (NO), malondialdehyde (MDA), and superoxide dismutase (SOD)
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day
L-Carnitine→Improved Total Antioxidant Capacity
serum levels of C-reactive protein (CRP), total antioxidant capacity (TAC), nitric oxide (NO), malondialdehyde (MDA), and superoxide dismutase (SOD)
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day
L-Carnitine→Reduced C-Reactive Protein Levels
serum levels of C-reactive protein (CRP), total antioxidant capacity (TAC), nitric oxide (NO), malondialdehyde (MDA), and superoxide dismutase (SOD)
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day
L-Carnitine→Reduced Malondialdehyde
serum levels of C-reactive protein (CRP), total antioxidant capacity (TAC), nitric oxide (NO), malondialdehyde (MDA), and superoxide dismutase (SOD)
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day
L-Carnitine→Reduced Migraine Duration
The primary outcomes include changes in clinical symptoms of migraine, including frequency, severity, and duration of attacks
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day
L-Carnitine→Reduced Migraine Frequency
The primary outcomes include changes in clinical symptoms of migraine, including frequency, severity, and duration of attacks
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day
L-Carnitine→Reduced Migraine Severity
The primary outcomes include changes in clinical symptoms of migraine, including frequency, severity, and duration of attacks
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day
L-Carnitine→Reduced Nitric Oxide Level
serum levels of C-reactive protein (CRP), total antioxidant capacity (TAC), nitric oxide (NO), malondialdehyde (MDA), and superoxide dismutase (SOD)
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day