NCT05085483

Ketone for Migraine Prevention

Efficacy of an Orally Administrated Nutritional Ketogenic Supplement, for the Prevention of Episodic Migraine: a Randomized, Double-blind, Placebo-controlled, Cross-over Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Efficacy of a nutritional ketogenic supplement (NKS) in reducing the number, intensity, and duration of migraine headaches in episodic migraine patients.

Detailed description

The KEMIP study is a randomized, placebo-controlled, double-blind, full cross-over, study to test the efficacy of NKS at reducing migraine days per month (MDM) compared to placebo in episodic migraine participants. Participants will prompted to enter data on migraine headache features (duration, pain intensity, medication use, symptoms) and product intake in an eDiary every day throughout the course of the study. Each participant will complete five steps of 1 month each: (1) baseline evaluation; (2) NKS/placebo intake; (3) washout \& cross-over; (4) NKS/placebo intake; (5) follow-up

Conditions

• Migraine Headache

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional Ketogenic Supplement	This trial has 5 steps: (1) a 4-week run-in baseline; (2) a 4-week intervention phase to either active or placebo (3) a 4-week phase of washout; (4) the cross-over to the second 4-week active or placebo phase; (5) a 4-week follow-up.
DIETARY_SUPPLEMENT	Isocaloric placebo supplement	Isocaloric placebo supplement

Timeline

• Start date: 2021-10-11
• Primary completion: 2022-11-28
• Completion: 2022-11-28
• First posted: 2021-10-20
• Last updated: 2023-03-24

Locations

1 site across 1 country: Canada