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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Ketosis; Cognitive Impairments, Mild
• Intervention / Treatment: Other: Coconut oil; Other: Sunflower oil

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH1 3LH
      • Bournemouth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vegetable oil usage	the amount of oil used by individuals (ml) will be monitored	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall cognition	Assessed by Mini Addenbrookes Cognitive Examination (mACE) which has a high score of 30 with higher scores indicating better cognition.	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.	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).	six months
Blood samples (beta hydroxyl butyrate):	ketone bodies concentrations (mmol) will be assessed by Abbott freestyle Optium Neo, ketone meter.	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	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.	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	six months
Processing Speed	Digit symbol test in which lower test scores are correlated with higher impairment will be used to assess processing speed	six months
Attention	Digit Span test will be used to assess attention, the lower the score the higher the impairment.	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.	six months

Collaborators and Investigators

• Sponsor: Bournemouth University
• Collaborators: Dorset HealthCare University NHS Foundation Trust
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): May 6, 2021
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Cognition Disorders; Acid-Base Imbalance; Acidosis; Cognitive Dysfunction; Ketosis
• Other Study ID Numbers: 1718/IRASREZ/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No