Clinical trial NCT03727386: The Effect of Vegetable Oil on Cognitive Functions of MCI Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Ketosis
Cognitive Impairments, Mild
Lead sponsor: Bournemouth University
Sponsor class: OTHER
Collaborators: name: Dorset HealthCare University NHS Foundation Trust
First posted: 2018-11-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Vegetable oil usage
timeFrame: 6 months
Secondary outcomes:
measure: Overall cognition
timeFrame: Six months
measure: 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)
timeFrame: six months
measure: Dietary intake assessed by four day food records using Nutritics software
timeFrame: six months
measure: Blood samples (beta hydroxyl butyrate):
timeFrame: six months
measure: Executive measure
timeFrame: six months
measure: Verbal Memory
timeFrame: six months
measure: Verbal Fluency
timeFrame: six months
measure: Processing Speed
timeFrame: six months
measure: Attention
timeFrame: six months
measure: Visual Spatial memory
timeFrame: six months
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Bournemouth University
state: Dorset
Study officials:
affiliation: Student
name: Raysa EL Zein, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Nutrition
name: Jane Murphy Professor, PhD
role: STUDY_DIRECTOR
affiliation: Professor of Health Care Stats & Epidemiology
name: Peter Thomas Professor, PhD
role: STUDY_DIRECTOR
affiliation: Lucturer of Psychology
name: Shanti Shanker Doctor, PhD
role: STUDY_DIRECTOR
References: