Ketone for Migraine Prevention

NCT ID: NCT05085483

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2022-11-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active intervention (one month)

Nutritional Ketogenic Supplement (NKS) 2 x 12 g of EKS/day

Group Type: EXPERIMENTAL

Nutritional Ketogenic Supplement

Intervention Type: DIETARY_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.

Placebo (one month)

Isocaloric placebo supplement

Group Type: PLACEBO_COMPARATOR

Isocaloric placebo supplement

Intervention Type: DIETARY_SUPPLEMENT

Isocaloric placebo supplement

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Isocaloric placebo supplement

Isocaloric placebo supplement

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Men and women aged ≥18 years who have previously been diagnosed with migraine, with or without aura, in accordance with the ICHD-3 Classification criteria;
• Have an estimated frequency of 5 to 14 MDM in each of the 3 months prior to enrolment;
• In principle, agree at the beginning (virtual call V0) to adequately complete a headache electronic diary (e-Diary) on at least 24 days out of the 28 days in the run-in baseline period;
• In practice, adequately complete by the end of V1 a headache eDiary on at least 24 days out of the 28 days in the run-in baseline period;
• Agree to refrain from initiating or changing the type, dosage, or frequency of any prophylactic medications against migraine, and any treatments for indications other than migraine that in the opinion of the clinician may interfere with the study objectives, e.g. antidepressants, anticonvulsants, beta-blockers, etc. for the duration of the study;
• Women of childbearing potential must agree to use a medically effective form of contraception, unless they can confirm they've had bilateral tubal ligation or that their male partner has had a vasectomy (provided that the partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success). Medically effective forms of contraception include hormonal methods, such as the contraceptive pill or implant (stable use for at least 3 months prior to enrolment), an intrauterine device (IUD) in use at least 30 days before enrolment, or barrier methods such as diaphragm plus spermicide or condom plus spermicide, in use at least 14 days before enrolment. In circumstances in which hormonal methods may interfere with the action of the IP or placebo, or in which the use of spermicides may increase the risk of transmission of disease, a double-barrier method is recommended.
• Agree to refrain from making any drastic changes to their usual diet for the duration of the study, particularly periods of fasting;
• Have a smartphone with Android or mobile operating system version compatible with eDiary;
• Able to provide informed consent

Exclusion Criteria

Under ketogenic diet, or using exogenous ketone supplements, e.g. medium chain triglycerides (MCT) 1 month prior to the initiation of the study or during the study;

• Patients using regular high dose of Vitamin B3, calcium (>1 g/day) or magnesium (>350 mg/day) supplements 1 month prior to the initiation of the study or during the study;
• Suffer from other primary (e.g. tension-type headache, trigeminal autonomic cephalalgias, other primary headache disorders) or secondary headaches (e.g. headaches attributed to trauma or injury, vascular or non-vascular intracranial disorders, substances or their withdrawal, infections, alterations of homeostasis), hemiplegic migraine;
• Pregnancy or intending to become pregnant, or is of childbearing potential and has not had tubal ligation, has a male partner who has not had a successful vasectomy, and is unwilling to use a medically effective form of contraception, i.e. oral contraceptive pills, injectable, or implantable contraceptive; intrauterine device; or double-barrier method (e.g. diaphragm and condom), or is lactating during the study duration. In addition, women of child-bearing potential on hormone-based contraception should not intend to stop or change their contraceptive for the duration of the study;
• Significant medical history, for example diabetes mellitus, renal stones, kidney and liver failure, somatic or psychiatric conditions, uncontrolled hypertension or medicated for hypertension, known hypercalcemia, history of or current cardiovascular disease, chronic gastrointestinal (GI) disease or intestinal malabsorption, or other illness, disease or syndrome which the investigators deem unsuitable to participate in the study;
• Significant medication history, for example use of corticosteroids in format of oral or injectable;
• Vaccination planned 2 weeks prior the start of the study, or during the study;
• Patients following a sodium-restricted diet;
• History of chronic alcohol or substance misuse;
• Previously diagnosed food allergy;
• Is participating in another clinical trial or has participated in a clinical trial the preceding month.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healint Pte Ltd

UNKNOWN

Sponsor Role: collaborator

Diex Research Sherbrooke Inc.

UNKNOWN

Sponsor Role: collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ginette Girard, MD

Role: PRINCIPAL_INVESTIGATOR

Diex Research Sherbrooke Inc.

Locations

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

20.08.NRC

Identifier Type: -

Identifier Source: org_study_id