The Effect of Vegetable Oil on Cognitive Functions of MCI Patients (DICe)
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|ClinicalTrials.gov Identifier: NCT03727386|
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : October 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Ketosis Cognitive Impairments, Mild||Other: Coconut oil Other: Sunflower oil||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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)|
|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|
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.
- Vegetable oil usage [ Time Frame: 6 months ]the amount of oil used by individuals (ml) will be monitored
- 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.
- 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.
- 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.
- Blood samples (beta hydroxyl butyrate): [ Time Frame: six months ]ketone bodies concentrations (mmol) will be assessed by Abbott freestyle Optium Neo, ketone meter.
- 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
- 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.
- 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
- 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
- Attention [ Time Frame: six months ]Digit Span test will be used to assess attention, the lower the score the higher the impairment.
- 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.
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
|Contact: Raysa El Zein, MSc.||012029 ext firstname.lastname@example.org|
|Contact: Suzy Wignall||012029 ext email@example.com|
|Bournemouth, Dorset, United Kingdom, BH1 3LH|
|Contact: Raysa EL Zein, MSc., BSc. 012029 ext 62097 firstname.lastname@example.org|
|Contact: Professor Jane Murphy, PhD 012029 ext 62805 email@example.com|
|Principal Investigator: Raysa El Zein, MSc., BSc.|
|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|