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Effects of moderate-carbohydrate diet on migraine

The effects of moderate-carbohydrate diet on migraine headache characteristics, gut microbiota, and calcitonin gene-related peptide (CGRP) in women with episodic migraine: a randomized controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250414065326N1
Enrollment
48
Registered
2025-05-29
Start date
2025-04-28
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine. Migraine

Interventions

Intervention 1: Intervention group: Moderate-carbohydrate diet (35-40% carbohydrates, 40-45% fat, and 20% protein) with a minimum fiber intake of 25 grams per day. Intervention 2: Control group: The c

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Female, aged 18–45 years BMI between 18.5 and 30 kg/m² Female have been on a stable dose of prophylactic migraine medication for at least one month before enrollment

Exclusion criteria

Exclusion criteria: BMI outside the range of 18.5–30 kg/m² Pregnancy, lactation, menopause, smoking, alcohol abuse Significant medical conditions such as major psychiatric disorders, autoimmune diseases, or chronic gastrointestinal, diabetes, cancer, liver, or kidney diseases Current use of certain medications or supplements, including probiotics, or antibiotics less than one month before the study, or those using CGRP inhibitors, neuroleptics (antidepressants), opioid drugs, thiazide diuretics, glucocorticoids, statins, orlistat, or weight-affecting supplements, dietary supplements

Design outcomes

Primary

MeasureTime frame
Migraine Symptoms Assessment. Timepoint: Monthly. Method of measurement: questionnaire.;Serum concentrations of Calcitonin gene-related peptide (CGRP). Timepoint: At the beginning and end of the study. Method of measurement: ELISA kits.

Secondary

MeasureTime frame
Serum concentrations of serotonin and calcitonin gene-related peptide (CGRP). Timepoint: Beginning and end of the study. Method of measurement: ELISA kits.;Gut microbiota assessment including Bifidobacterium, Ruminococcus, Lactobacillus, and the Firmicutes to Bacteroidetes ratio. Timepoint: beginning and end of the study. Method of measurement: Absolute-Real-time-PCR.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeedeh Nouri-Majd

Tehran University of Medical Sciences

Snourimajd@gmail.com+98 21 8895 5742

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026