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

Primary Purpose

Metabolic Ketosis, Cognitive Impairments, Mild

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Coconut oil
Sunflower oil
Sponsored by
Bournemouth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Ketosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bournemouth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Coconut oil

Sunflower oil

Arm Description

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. .

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.

Outcomes

Primary Outcome Measures

Vegetable oil usage
the amount of oil used by individuals (ml) will be monitored

Secondary Outcome Measures

Overall cognition
Assessed by Mini Addenbrookes Cognitive Examination (mACE) which has a high score of 30 with higher scores indicating better cognition.
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.
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).
Blood samples (beta hydroxyl butyrate):
ketone bodies concentrations (mmol) will be assessed by Abbott freestyle Optium Neo, ketone meter.
Executive measure
Assessed by trail making test B that has an average score of 75 seconds and a deficient score of > 273 seconds
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.
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
Processing Speed
Digit symbol test in which lower test scores are correlated with higher impairment will be used to assess processing speed
Attention
Digit Span test will be used to assess attention, the lower the score the higher the impairment.
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.

Full Information

First Posted
July 13, 2018
Last Updated
June 28, 2021
Sponsor
Bournemouth University
Collaborators
Dorset HealthCare University NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03727386
Brief Title
The Effect of Vegetable Oil on Cognitive Functions of MCI Patients
Acronym
DICe
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
May 6, 2021 (Actual)
Study Completion Date
May 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bournemouth University
Collaborators
Dorset HealthCare University NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Ketosis, Cognitive Impairments, Mild

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coconut oil
Arm Type
Experimental
Arm Description
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. .
Arm Title
Sunflower oil
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Coconut oil
Other Intervention Name(s)
extra virgin coconut oil
Intervention Description
Participants will receive 30 ml of virgin coconut oil to replace their normal oil intake for a period of 6 months.
Intervention Type
Other
Intervention Name(s)
Sunflower oil
Intervention Description
Participants will receive 30 ml of sunflower oil to replace their normal oil intake for a period of 6 months.
Primary Outcome Measure Information:
Title
Vegetable oil usage
Description
the amount of oil used by individuals (ml) will be monitored
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall cognition
Description
Assessed by Mini Addenbrookes Cognitive Examination (mACE) which has a high score of 30 with higher scores indicating better cognition.
Time Frame
Six months
Title
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)
Description
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.
Time Frame
six months
Title
Dietary intake assessed by four day food records using Nutritics software
Description
Dietary energy and macronutrient (carbohydrate, fat and protein) intake assessed by four day food records using Nutritics software (https://www.nutritics.com/p/references).
Time Frame
six months
Title
Blood samples (beta hydroxyl butyrate):
Description
ketone bodies concentrations (mmol) will be assessed by Abbott freestyle Optium Neo, ketone meter.
Time Frame
six months
Title
Executive measure
Description
Assessed by trail making test B that has an average score of 75 seconds and a deficient score of > 273 seconds
Time Frame
six months
Title
Verbal Memory
Description
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.
Time Frame
six months
Title
Verbal Fluency
Description
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
Time Frame
six months
Title
Processing Speed
Description
Digit symbol test in which lower test scores are correlated with higher impairment will be used to assess processing speed
Time Frame
six months
Title
Attention
Description
Digit Span test will be used to assess attention, the lower the score the higher the impairment.
Time Frame
six months
Title
Visual Spatial memory
Description
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.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raysa EL Zein, MSc
Organizational Affiliation
Student
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane Murphy Professor, PhD
Organizational Affiliation
Professor of Nutrition
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter Thomas Professor, PhD
Organizational Affiliation
Professor of Health Care Stats & Epidemiology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shanti Shanker Doctor, PhD
Organizational Affiliation
Lucturer of Psychology
Official's Role
Study Director
Facility Information:
Facility Name
Bournemouth University
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH1 3LH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers.

Learn more about this trial

The Effect of Vegetable Oil on Cognitive Functions of MCI Patients

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