Migraine HeadacheNCT05085483
Ketone for Migraine Prevention
A study testing Nutritional Ketogenic Supplement in people with Migraine Headache, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
Trial summary
Efficacy of a nutritional ketogenic supplement (NKS) in reducing the number, intensity, and duration of migraine headaches in episodic migraine patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Nutritional Ketogenic Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 11 Oct 2021to 28 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Orally Administrated Nutritional Ketogenic Supplement, for the Prevention of Episodic Migraine: a Randomized, Double-blind, Placebo-controlled, Cross-over Trial
Efficacy of a nutritional ketogenic supplement (NKS) in reducing the number, intensity, and duration of migraine headaches in episodic migraine patients.
Read the 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
- Being tested
- Nutritional Ketogenic Supplement, Isocaloric placebo supplement
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Ketogenic SupplementDietary 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.
Isocaloric placebo supplementDietary supplement
Isocaloric placebo supplement
| Study group | Role | What they receive |
|---|---|---|
| Active intervention (one month) | Experimental | Nutritional Ketogenic Supplement (NKS) 2 x 12 g of EKS/day Receives: Dietary Supplement: Nutritional Ketogenic Supplement |
| Placebo (one month) | Placebo comparator | Isocaloric placebo supplement Receives: Dietary Supplement: Isocaloric placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in MDM versus placebo
Headache eDiary will be used to record the change in monthly migraine frequency according to ICHD-3 guidelines. The headache diary captures information on date, time of onset and resolution, distinction of migraine from headache based on symptoms, pain intensity and use of acute medication
Measured: 1 month
Secondary outcomes (6)
Mean change from baseline in the number of headache days of any severity (headache, migraine or probable migraine, and migraine attacks)
Measured: 1 month
Proportion of responders: responders are defined as patients who had a greater than 50%, 75% or 100% reduction in MDM
Measured: 1 month
Reduction in the use of acute medication for migraine
Measured: 1 month
Mean change from baseline in migraine intensity measured with a numerical rating scale from 1 to 10;
Measured: 1 month
Mean change from baseline in the average migraine duration
Measured: 1 month
Incidence, severity and relatedness of adverse events
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start11 Oct 2021
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Healint Pte Ltd, Diex Research Sherbrooke Inc.
- Responsible party
- Sponsor
- Investigators
- Ginette Girard, MD, Principal investigator, Diex Research Sherbrooke Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085483
- Sponsor's protocol ID
- 20.08.NRC
- Status last verified
- Mar 2023
- First submitted
- 18 Oct 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Orally Administrated Nutritional Ketogenic Supplement, for the Prevention of Episodic Migraine: a Randomized, Double-blind, Placebo-controlled, Cross-over Trial
- ClinicalTrials.gov ID
- NCT05085483
- Acronym / sponsor ID
- 20.08.NRC
- Conditions
- Migraine Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Healint Pte Ltd, Diex Research Sherbrooke Inc.
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active intervention (one month) | Experimental | Dietary Supplement: Nutritional Ketogenic SupplementNutritional Ketogenic Supplement (NKS) 2 x 12 g of EKS/day |
| Placebo (one month) | Placebo comparator | Dietary Supplement: Isocaloric placebo supplementIsocaloric placebo supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional Ketogenic SupplementThis 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 | Active intervention (one month) |
| Isocaloric placebo supplementIsocaloric placebo supplement | Dietary supplement | Placebo (one month) |
Primary outcome
Mean change from baseline in MDM versus placebo
Time frame: 1 month
Headache eDiary will be used to record the change in monthly migraine frequency according to ICHD-3 guidelines. The headache diary captures information on date, time of onset and resolution, distinction of migraine from headache based on symptoms, pain intensity and use of acute medication
6 secondary outcomes
Mean change from baseline in the number of headache days of any severity (headache, migraine or probable migraine, and migraine attacks)
Time frame: 1 month
Proportion of responders: responders are defined as patients who had a greater than 50%, 75% or 100% reduction in MDM
Time frame: 1 month
Reduction in the use of acute medication for migraine
Time frame: 1 month
Mean change from baseline in migraine intensity measured with a numerical rating scale from 1 to 10;
Time frame: 1 month
Mean change from baseline in the average migraine duration
Time frame: 1 month
Incidence, severity and relatedness of adverse events
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ginette Girard, MD principal investigator
Diex Research Sherbrooke Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Ketogenic Supplement in people with Migraine Headache, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in MDM versus placebo (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.