ArticleTrials2023
Effect of inulin supplementation on clinical symptoms, inflammatory and oxidative stress markers in women with migraine: study protocol for a randomized clinical trial.
Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- Pooled it
- Inulin as a Modulator of the Intestinal Barrier: Experimental Evidence, Mechanisms and Clinical Implications.Biomedicines · 2026Review
- Review
- Association of controlling nutritional status with fecal incontinence and fecal incontinence severity index in individuals with spinal cord injury: mediating roles of interleukin-6 and uric acid.Frontiers in nutrition · 2026Article
- The Role of Probiotics, Prebiotics, Synbiotics, and Postbiotics in Livestock and Poultry Gut Health: A Review.Metabolites · 2025Review
- Polydextrose-driven gut microbiota modulation from synbiotic yogurt intake simulated in theFrontiers in nutrition · 2025Article
- The role of Chinese herbal medicine in the regulation of oxidative stress in treating hypertension: from therapeutics to mechanisms.Chinese medicine · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMigraine is a complex, chronic, and debilitating multifactorial disorder characterized by recurrent episodes of headache and related symptoms. It typically begins in early ages and is more prevalent in women than in men. Recently, the gut-brain axis has emerged as a new candidate that may be linked to neurological diseases. We hypothesize that selective modulation of the intestinal microbiota, oxidative stress, and inflammation through inulin supplementation may improve clinical outcomes in these patients. Therefore, this study aims to examine the effects of high-performance inulin supplementation on clinical symptoms, mental health, quality of life (QOL), intestinal permeability, and inflammatory and oxidative stress factors in women with migraine.
methodsThis is a randomized, double-blind, placebo-controlled clinical trial involving 80 women with migraine who meet the inclusion criteria (aged between 20 and 50 years with a diagnosis of migraine by a neurologist based on the ICDH-3). Participants will be assigned to receive a daily dose of 10 g of inulin for 12 weeks (intervention group, n = 40) or 10 g of maltodextrin as a placebo for the same duration (control group, n = 40). The primary outcome will measure the variations in the frequency of headache experienced by the patients. Secondary outcomes will encompass serum levels of zonulin, high-sensitive C-reactive protein, total antioxidant capacity, total oxidant status, nitric oxide, mental status, QOL, duration, and severity of migraine attacks. DISCUSSION: This clinical trial aims to evaluate the effect of inulin supplementation on inflammatory status, oxidative stress, intestinal permeability, clinical symptoms, mental health, and QOL in women with migraine. The findings of this trial could contribute to the identification of mechanistic action and evidence-based clinical guidelines that address gut microbiota manipulation to maximize health benefits in the management of clinical outcomes in migraine patients.
trial registrationIranian Registry of Clinical Trials ( www.irct.ir ) (ID: IRCT20121216011763N58). Registration date: 23 April 2023. TRIAL STATUS: The protocol is version 3.0, September 17, 2023. Recruitment began August 21, 2023, and is anticipated to be completed by March 22, 2024.
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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.