Metabolic KetosisDICeNCT03727386
The Effect of Vegetable Oil on Cognitive Functions of MCI Patients
A study testing Coconut oil and Sunflower oil in people with Metabolic Ketosis and Cognitive Impairments, Mild, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
This study explores the feasibility of applying an intervention using vegetable oils (coconut and sunflower oils) on individuals diagnosed with Mild Cognitive Impairment. Participants will be divided into two groups and will either receive 30 ml of coconut or sunflower oil to be consumed daily for six months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Ketosis, Cognitive Impairments, Mild
- What is being tested?
- Coconut oil and Sunflower oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Nov 2019to 6 May 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with confirmed MCI diagnosis
- Adults with Negative Apo E4 genotype
Who cannot join
- Adults diagnosed with Alzheimer's Disease (AD)
- Adults with positive Apo E4 genotype
- Adults with confirmed diabetes (Type I, Type II) diagnosis
- Adults with a history of hyper-cholesterolemia (high cholesterol levels) or Dyslipidaemia
- Adults who are unable to understand written or verbal English
- Adults diagnosed with Neurological disorders (Parkinson, stroke…)
Show all 9Show fewer
- Adults with post traumatic brain injury (tumour, brain surgery, injury…)
- Patients with major physical impairments (blind, deaf) or those who are unable to use their dominant hand.
- Adults with coconut allergy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bournemouth University
Bournemouth, Dorset, BH1 3LH
About this study
Official title: A Study Evaluating the Feasibility of Undertaking an Intervention Looking Into the Effect of Vegetable Oils Intake on Cognition and Quality of Life in Adults With Mild Cognitive Impairment.
This study explores the feasibility of applying an intervention using vegetable oils (coconut and sunflower oils) on individuals diagnosed with Mild Cognitive Impairment. Participants will be divided into two groups and will either receive 30 ml of coconut or sunflower oil to be consumed daily for six months.
Read the detailed description
Research has shown that some forms of dementia associated to ageing can often be linked to low levels of sugar in the brain. Which may cause damage to the brain nerve cells. The main source of fuel for the brain comes from sugar in the form of glucose. Providing an additional source of fuel to brain cells may reduce the damage, potentially preventing further decline of dementia in individuals with Mild Cognitive Impairment (MCI).
This study explores the possibility of using vegetable oils (coconut and sunflower oils) as an additional source of energy to individuals diagnosed with Mild Cognitive Impairment. The researchers will use different tests to evaluate if the study could be done. Participants will be divided into two groups and will either receive 30 ml of coconut or sunflower oil to be consumed daily for six months. The researchers will visit participants in their houses over three times during the study to collect the data.
During each visit, the researcher will conduct blood test in which blood will be collected by pricking the finger of participants to check their blood ketone levels. Paper pencil and/or computer tasks will be completed to measure the cognitive abilities (e.g. attention, orientation and learning) of participants. Participants will also be asked to complete a food diary in which they will provide details of their diet and eating habits. Moreover, they will be asked to provide feedback on the study by answering a set of questions either during an interview or by completing a feedback form. The information collected during these visits will be used to evaluate the study.
Results from this study would help determine whether such an intervention can be undertaken in adults with MCI. The study will provide information related to the practicality of using vegetable oils on adults with MCI. This would provide the evidence to develop a larger study that would allow us to systematically evaluate the effect of vegetable oils on MCI. Which would further enable us to develop an intervention that might possibly improve the brain functions of adults with MCI and maintain their quality of life for longer by delaying the development of dementia and reducing the progression from MCI to AD (Alzheimer's disease) in adults.
- Conditions
- Metabolic Ketosis, Cognitive Impairments, Mild
- Being tested
- Coconut oil, Sunflower oil
- Medical subject headings
- Ketosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut oilOther
Also called extra virgin coconut oil
Participants will receive 30 ml of virgin coconut oil to replace their normal oil intake for a period of 6 months.
Sunflower oilOther
Participants will receive 30 ml of sunflower oil to replace their normal oil intake for a period of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Coconut oil | Experimental | A dietary intervention that relies on the administration of 30 ml of extra virgin coconut oil per day for six months will be utilized in this study. Coconut oil administered will replace the cooking/vegetable oil usually used by the participants. . Receives: Other: Coconut oil |
| Sunflower oil | Placebo comparator | A dietary intervention that relies on the administration of 30 ml of sunflower oil per day for 6 months will be utilized in this study. The oil administered will replace the cooking/vegetable oil usually used by the participants. Receives: Other: Sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vegetable oil usage
the amount of oil used by individuals (ml) will be monitored
Measured: 6 months
Secondary outcomes (10)
Overall cognition
Assessed by Mini Addenbrookes Cognitive Examination (mACE) which has a high score of 30 with higher scores indicating better cognition.
Measured: Six months
Quality of life of adults with Mild cognitive impairment measured by ADCS-MCI-ADL (Alzheimer's Disease Cooperative Study Mild Cognitive Impairment- Activities of Daily Living)
Quality of life of participants measured by ADCS-MCI-ADL (Alzheimer's Disease Cooperative Study Mild Cognitive Impairment- Activities of Daily Living) questionnaire, it has a score that rages from 0 to 53; higher score are linked to better quality of life.
Measured: six months
Dietary intake assessed by four day food records using Nutritics software
Dietary energy and macronutrient (carbohydrate, fat and protein) intake assessed by four day food records using Nutritics software (https://www.nutritics.com/p/references).
Measured: six months
Blood samples (beta hydroxyl butyrate):
ketone bodies concentrations (mmol) will be assessed by Abbott freestyle Optium Neo, ketone meter.
Measured: six months
Executive measure
Assessed by trail making test B that has an average score of 75 seconds and a deficient score of > 273 seconds
Measured: six months
Verbal Memory
Verbal memory will be assessed by word list test which is a subtest of the Wechsler Memory Scale III; the lower the test score the higher the cognitive impairment.
Measured: six months
Verbal Fluency
Verbal Fluency test in which a score lower than 17 shows cognitive impairment (the higher the score the better the cognition) will be used to determine
Measured: six months
Processing Speed
Digit symbol test in which lower test scores are correlated with higher impairment will be used to assess processing speed
Measured: six months
Attention
Digit Span test will be used to assess attention, the lower the score the higher the impairment.
Measured: six months
Visual Spatial memory
Supermarket task will be used to asses the visual spatial memory of participants, the score depends on the time required to complete the task. Extra time is related to higher cognitive impairment.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start19 Nov 2019
- Primary completion6 May 2021
- Study completion6 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic KetosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a pilot study with an internal feasibility study that aims at evaluating the acceptance and adherence of participants to the intervention. Participants will be randomized into an intervention (coconut oil) and control group (sunflower oil) using an online randomisation software; Sealed envelope.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Dorset HealthCare University NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Raysa EL Zein, MSc, Principal investigator, StudentJane Murphy Professor, PhD, Study director, Professor of NutritionPeter Thomas Professor, PhD, Study director, Professor of Health Care Stats & EpidemiologyShanti Shanker Doctor, PhD, Study director, Lucturer of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727386
- Sponsor's protocol ID
- 1718/IRASREZ/1
- Acronym
- DICe
- Status last verified
- Jun 2021
- First submitted
- 13 Jul 2018
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Feasibility of Undertaking an Intervention Looking Into the Effect of Vegetable Oils Intake on Cognition and Quality of Life in Adults With Mild Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT03727386
- Acronym / sponsor ID
- DICe / 1718/IRASREZ/1
- Conditions
- Metabolic Ketosis, Cognitive Impairments, Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Dorset HealthCare University NHS Foundation Trust
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 1 Nov 2018 (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.
This study explores the feasibility of applying an intervention using vegetable oils (coconut and sunflower oils) on individuals diagnosed with Mild Cognitive Impairment. Participants will be divided into two groups and will either receive 30 ml of coconut or sunflower oil to be consumed daily for six months.
Detailed description
Research has shown that some forms of dementia associated to ageing can often be linked to low levels of sugar in the brain. Which may cause damage to the brain nerve cells. The main source of fuel for the brain comes from sugar in the form of glucose. Providing an additional source of fuel to brain cells may reduce the damage, potentially preventing further decline of dementia in individuals with Mild Cognitive Impairment (MCI).
This study explores the possibility of using vegetable oils (coconut and sunflower oils) as an additional source of energy to individuals diagnosed with Mild Cognitive Impairment. The researchers will use different tests to evaluate if the study could be done. Participants will be divided into two groups and will either receive 30 ml of coconut or sunflower oil to be consumed daily for six months. The researchers will visit participants in their houses over three times during the study to collect the data.
During each visit, the researcher will conduct blood test in which blood will be collected by pricking the finger of participants to check their blood ketone levels. Paper pencil and/or computer tasks will be completed to measure the cognitive abilities (e.g. attention, orientation and learning) of participants. Participants will also be asked to complete a food diary in which they will provide details of their diet and eating habits. Moreover, they will be asked to provide feedback on the study by answering a set of questions either during an interview or by completing a feedback form. The information collected during these visits will be used to evaluate the study.
Results from this study would help determine whether such an intervention can be undertaken in adults with MCI. The study will provide information related to the practicality of using vegetable oils on adults with MCI. This would provide the evidence to develop a larger study that would allow us to systematically evaluate the effect of vegetable oils on MCI. Which would further enable us to develop an intervention that might possibly improve the brain functions of adults with MCI and maintain their quality of life for longer by delaying the development of dementia and reducing the progression from MCI to AD (Alzheimer's disease) in adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be a pilot study with an internal feasibility study that aims at evaluating the acceptance and adherence of participants to the intervention. Participants will be randomized into an intervention (coconut oil) and control group (sunflower oil) using an online randomisation software; Sealed envelope.
| Arm | Type | Receives |
|---|---|---|
| Coconut oil | Experimental | Other: Coconut oilA dietary intervention that relies on the administration of 30 ml of extra virgin coconut oil per day for six months will be utilized in this study. Coconut oil administered will replace the cooking/vegetable oil usually used by the participants. . |
| Sunflower oil | Placebo comparator | Other: Sunflower oilA dietary intervention that relies on the administration of 30 ml of sunflower oil per day for 6 months will be utilized in this study. The oil administered will replace the cooking/vegetable oil usually used by the participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with confirmed MCI diagnosis
- Adults with Negative Apo E4 genotype
Key exclusion criteria (9 listed)
- Adults diagnosed with Alzheimer's Disease (AD)
- Adults with positive Apo E4 genotype
- Adults with confirmed diabetes (Type I, Type II) diagnosis
- Adults with a history of hyper-cholesterolemia (high cholesterol levels) or Dyslipidaemia
- Adults who are unable to understand written or verbal English
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 |
|---|---|---|
| Coconut oilAlso: extra virgin coconut oilParticipants will receive 30 ml of virgin coconut oil to replace their normal oil intake for a period of 6 months. | Other | Coconut oil |
| Sunflower oilParticipants will receive 30 ml of sunflower oil to replace their normal oil intake for a period of 6 months. | Other | Sunflower oil |
Primary outcome
Vegetable oil usage
Time frame: 6 months
the amount of oil used by individuals (ml) will be monitored
10 secondary outcomes
Overall cognition
Time frame: Six months
Quality of life of adults with Mild cognitive impairment measured by ADCS-MCI-ADL (Alzheimer's Disease Cooperative Study Mild Cognitive Impairment- Activities of Daily Living)
Time frame: six months
Dietary intake assessed by four day food records using Nutritics software
Time frame: six months
Blood samples (beta hydroxyl butyrate):
Time frame: six months
Executive measure
Time frame: six months
Verbal Memory
Time frame: six months
Verbal Fluency
Time frame: six months
Processing Speed
Time frame: six months
Attention
Time frame: six months
Visual Spatial memory
Time frame: six 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 29 Jun 2021.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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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.
Raysa EL Zein, MSc principal investigator
Student
Jane Murphy Professor, PhD study director
Professor of Nutrition
Peter Thomas Professor, PhD study director
Professor of Health Care Stats & Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coconut oil and Sunflower oil in people with Metabolic Ketosis and Cognitive Impairments, Mild, run by Bournemouth University at 1 site in United Kingdom.
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 2 inclusion and 9 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 29 Jun 2021. 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 United Kingdom. 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?
Vegetable oil usage (time frame: 6 months). 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 29 Jun 2021.