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The Effect of Vegetable Oil on Cognitive Functions of MCI Patients (DICe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727386
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
Dorset HealthCare University NHS Foundation Trust
Information provided by (Responsible Party):
Bournemouth University

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Ketosis Cognitive Impairments, Mild Other: Coconut oil Other: Sunflower oil Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
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.
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Coconut oil
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. .
Other: Coconut oil
Participants will receive 30 ml of virgin coconut oil to replace their normal oil intake for a period of 6 months.
Other Name: extra virgin coconut oil

Placebo Comparator: Sunflower oil
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.
Other: Sunflower oil
Participants will receive 30 ml of sunflower oil to replace their normal oil intake for a period of 6 months.




Primary Outcome Measures :
  1. Vegetable oil usage [ Time Frame: 6 months ]
    the amount of oil used by individuals (ml) will be monitored


Secondary Outcome Measures :
  1. Overall cognition [ Time Frame: Six months ]
    Assessed by Mini Addenbrookes Cognitive Examination (mACE) which has a high score of 30 with higher scores indicating better cognition.

  2. 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 ]
    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.

  3. Dietary intake assessed by four day food records using Nutritics software [ Time Frame: six months ]
    Dietary energy and macronutrient (carbohydrate, fat and protein) intake assessed by four day food records using Nutritics software.

  4. Blood samples (beta hydroxyl butyrate): [ Time Frame: six months ]
    ketone bodies concentrations (mmol) will be assessed by Abbott freestyle Optium Neo, ketone meter.

  5. Executive measure [ Time Frame: six months ]
    Assessed by trail making test B that has an average score of 75 seconds and a deficient score of > 273 seconds

  6. Verbal Memory [ Time Frame: six months ]
    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.

  7. Verbal Fluency [ Time Frame: six months ]
    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

  8. Processing Speed [ Time Frame: six months ]
    Digit symbol test in which lower test scores are correlated with higher impairment will be used to assess processing speed

  9. Attention [ Time Frame: six months ]
    Digit Span test will be used to assess attention, the lower the score the higher the impairment.

  10. Visual Spatial memory [ Time Frame: six months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults with confirmed MCI diagnosis
  • Adults with Negative Apo E4 genotype

Exclusion Criteria:

  • 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…)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727386


Contacts
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Contact: Raysa El Zein, MSc. 012029 ext 62097 relzein@bournemouth.ac.uk
Contact: Suzy Wignall 012029 ext 61073 swignall@bournemouth.ac.uk

Locations
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United Kingdom
Bournemouth University Recruiting
Bournemouth, Dorset, United Kingdom, BH1 3LH
Contact: Raysa EL Zein, MSc., BSc.    012029 ext 62097    relzein@bournemouth.ac.uk   
Contact: Professor Jane Murphy, PhD    012029 ext 62805    jmurphy@bournemouth.ac.uk   
Principal Investigator: Raysa El Zein, MSc., BSc.         
Sponsors and Collaborators
Bournemouth University
Dorset HealthCare University NHS Foundation Trust
Investigators
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Principal Investigator: Raysa EL Zein, MSc Student
Study Director: Jane Murphy Professor, PhD Professor of Nutrition
Study Director: Peter Thomas Professor, PhD Professor of Health Care Stats & Epidemiology
Study Director: Shanti Shanker Doctor, PhD Lucturer of Psychology

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Responsible Party: Bournemouth University
ClinicalTrials.gov Identifier: NCT03727386     History of Changes
Other Study ID Numbers: 1718/IRASREZ/1
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ketosis
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Acidosis
Acid-Base Imbalance
Metabolic Diseases