The Effect of Vegetable Oil on Cognitive Functions of MCI Patients

NCT ID: NCT03727386

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2021-05-06

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.

Conditions

Metabolic Ketosis; Cognitive Impairments, Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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. .

Group Type: EXPERIMENTAL

Coconut oil

Intervention Type: OTHER

Participants will receive 30 ml of virgin coconut oil to replace their normal oil intake for a period of 6 months.

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.

Group Type: PLACEBO_COMPARATOR

Sunflower oil

Intervention Type: OTHER

Participants will receive 30 ml of sunflower oil to replace their normal oil intake for a period of 6 months.

Interventions

Coconut oil

Participants will receive 30 ml of virgin coconut oil to replace their normal oil intake for a period of 6 months.

Intervention Type: OTHER

Sunflower oil

Participants will receive 30 ml of sunflower oil to replace their normal oil intake for a period of 6 months.

Intervention Type: OTHER

Other Intervention Names

extra virgin coconut oil

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dorset HealthCare University NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Bournemouth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raysa EL Zein, MSc

Role: PRINCIPAL_INVESTIGATOR

Student

Jane Murphy Professor, PhD

Role: STUDY_DIRECTOR

Professor of Nutrition

Peter Thomas Professor, PhD

Role: STUDY_DIRECTOR

Professor of Health Care Stats & Epidemiology

Shanti Shanker Doctor, PhD

Role: STUDY_DIRECTOR

Lucturer of Psychology

Locations

Bournemouth University

Bournemouth, Dorset, United Kingdom

Countries

United Kingdom

Other Identifiers

1718/IRASREZ/1

Identifier Type: -

Identifier Source: org_study_id