Mild Cognitive Impairment (MCI)MCI-MCTNCT06951932
Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment
A study testing Mediterranean-type diet with MCT supplementation and Mediterranean-type food regimen using extra virgin olive oil in people with Mild Cognitive Impairment (MCI), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
Mild cognitive impairment (MCI) is considered the intermediate stage between the changes observed in physiological aging and dementia. Currently, there is no drug therapy, and available drugs offer only minimal benefit on symptoms, only partially slowing the course of the condition. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Mediterranean-type diet with MCT supplementation and Mediterranean-type food regimen using extra virgin olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jul 2024to 3 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years;
- Diagnosis of MCI;
- Disease duration of less than 24 months from symptom onset;
- Absence of malnutrition (diagnosed according to the NRS 2002 screening test) and with oral intakes sufficient to cover energy requirements (calculated by the Harris-Benedict formula, adjusted for activity factor and pathology);
- Ability to understand and sign informed consent.
Who cannot join
- Patients on total or supplemental enteral nutrition
- Severe dysphagia
- Patients with glycated hemoglobin > 8%
- Patients on insulin therapy
- Patients with poor beta-cell function (e.g., pancreasectomy, acute and chronic pancreatitis)
- Patients with liver failure: MELD score > 9
Show all 18Show fewer
- Malnutrition (diagnosed according to the NRS 2002 screening test) and with per os intakes < 60% of energy requirements (calculated using the Harris-Benedict formula, corrected for activity factor and pathology)
- Metabolic disorders and/or enzyme disorders, dyslipidemia with total cholesterolemia >300 mg/dl and/or triglyceridemia >400 mg/dl)
- Acute inflammatory disease or ongoing or recent (within 30 days) infectious states
- Hypo- and hyperthyroidism not adequately compensated by treatment
- Heart failure (NYHA III-IV), unstable angina, recent (<6 months) acute cardiovascular or cerebrovascular events
- Pregnancy or lactation
- Neurological disorders other than MCI, psychiatric disorders
- Nutrition and eating disorder
- Alcohol abuse
- Institutionalized patients
- Participation in experimental therapies in the 2 months prior to enrollment
- Allergy to MCT oil, nuts
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinical Trial Center
Alessandria, Piedmont, 15121
Clinical Trial Center, 0131206893, clinicaltrialcenter@ospedale.al.it
About this study
Official title: Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment: Prospective Randomized Controlled Trial
Mild cognitive impairment (MCI) is considered the intermediate stage between the changes observed in physiological aging and dementia. Currently, there is no drug therapy, and available drugs offer only minimal benefit on symptoms, only partially slowing the course of the condition. Studies in the literature have investigated the role of omega-3 fatty acids in MCI, and when administered over a period of six months, they appear to improve clinical condition and mood. In addition, medium-chain triglycerides (MCTs) appear to exert an antioxidant function, enhance cognitive ability in patients with MCI or Alzheimer's, and promote deep sleep state.
Read the detailed description
Mild cognitive impairment (MCI) is considered the intermediate stage between the changes observed in physiological aging and dementia. The need to diagnose MCI at an early stage is driven by the hypothesis that therapeutic interventions may be more effective in the early stages of the disease. In addition, many studies have shown that sleep disturbances can affect neurodegeneration and be used as a marker of disease, manifesting before cognitive impairment itself. Currently, there is no drug therapy, and available drugs offer only minimal benefit on symptoms, only partially slowing the course of the condition. Studies in the literature have investigated the role of omega-3 fatty acids in MCI, and when administered over a period of six months, they appear to improve clinical condition and mood. In addition, medium-chain triglycerides (MCTs) appear to exert an antioxidant function, enhance cognitive ability in patients with MCI or Alzheimer's, and promote deep sleep state
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Mediterranean-type diet with MCT supplementation, Mediterranean-type food regimen using extra virgin olive oil
- Keywords
- Montreal Cognitive Assessment, medium-chain triglycerides
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean-type diet with MCT supplementationDietary supplement
The treatment arm will follow a Mediterranean diet supplemented by daily intake of MCT (30 mL)
Mediterranean-type food regimen using extra virgin olive oilOther
The arm will follow a Mediterranean diet with an indication to take extra virgin olive oil as the main fat in the diet daily
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean-type food regimen using extra virgin olive oil | Active comparator | Patients with with first diagnosis of MCI referred to the S.C of Neurology and/or Geriatrics and/or Internal Medicine of the SS. Antonio e Biagio e Cesare Arrigo of Alessandria University Hospital, randomized into the control arm Receives: Other: Mediterranean-type food regimen using extra virgin olive oil |
| Mediterranean-type diet with MCT supplementation | Experimental | Patients with with first diagnosis of MCI referred to the S.C of Neurology and/or Geriatrics and/or Internal Medicine of the SS. Antonio e Biagio e Cesare Arrigo of Alessandria University Hospital, randomized into the experimental arm Receives: Dietary Supplement: Mediterranean-type diet with MCT supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of medium-chain triglycerides (MCT) intake on cognitive impairment
Evaluate the effect of medium-chain triglycerides (MCT) intake on cognitive decline in patients with first diagnosis of MCI through the use of the Montreal Cognitive Assessment (MoCA), that includes a series of tests of visuospatial/executive functions, naming, attention, language, abstraction, delayed recall, and orientation for a total score of 30 (best cognitive status).
Measured: 6 months after baseline
Secondary outcomes (2)
Positive effect of MCT intake on sleep quality
Evaluate the positive effect of MCT intake on sleep quality in patients with MCI using the Pittsburgh and Epworth Scales, sleep quality rating scales.
Measured: Baseline and 6 months after baseline
Evaluation of quality of life
Assessing quality of life through the QoL AD score (Quality of life in Alzheimer's Disease), characterized by 15 items that can be answered by choosing from four options that are scored from 1 (poor) to 4 (excellent). The total score ranges from 13 (worst quality of life) to 52 (best quality of life).
Measured: Baseline, 3 months after baseline and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start3 Jul 2024
- Primary completion3 Jul 2025 (estimated)
- Study completion3 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a nonpharmacological dietary supplement interventional study, controlled, randomized with two parallel arms
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Schär AG / SPA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951932
- Sponsor's protocol ID
- ASO.MedI.23.02
- Acronym
- MCI-MCT
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment: Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06951932
- Acronym / sponsor ID
- MCI-MCT / ASO.MedI.23.02
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Montreal Cognitive Assessment, medium-chain triglycerides
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Collaborators
- Dr. Schär AG / SPA
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 3 Jul 2025 (estimated)
- Study completion
- 3 Nov 2025 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mild cognitive impairment (MCI) is considered the intermediate stage between the changes observed in physiological aging and dementia. Currently, there is no drug therapy, and available drugs offer only minimal benefit on symptoms, only partially slowing the course of the condition. Studies in the literature have investigated the role of omega-3 fatty acids in MCI, and when administered over a period of six months, they appear to improve clinical condition and mood. In addition, medium-chain triglycerides (MCTs) appear to exert an antioxidant function, enhance cognitive ability in patients with MCI or Alzheimer's, and promote deep sleep state.
Detailed description
Mild cognitive impairment (MCI) is considered the intermediate stage between the changes observed in physiological aging and dementia. The need to diagnose MCI at an early stage is driven by the hypothesis that therapeutic interventions may be more effective in the early stages of the disease. In addition, many studies have shown that sleep disturbances can affect neurodegeneration and be used as a marker of disease, manifesting before cognitive impairment itself. Currently, there is no drug therapy, and available drugs offer only minimal benefit on symptoms, only partially slowing the course of the condition. Studies in the literature have investigated the role of omega-3 fatty acids in MCI, and when administered over a period of six months, they appear to improve clinical condition and mood. In addition, medium-chain triglycerides (MCTs) appear to exert an antioxidant function, enhance cognitive ability in patients with MCI or Alzheimer's, and promote deep sleep state
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a nonpharmacological dietary supplement interventional study, controlled, randomized with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Mediterranean-type food regimen using extra virgin olive oil | Active comparator | Other: Mediterranean-type food regimen using extra virgin olive oilPatients with with first diagnosis of MCI referred to the S.C of Neurology and/or Geriatrics and/or Internal Medicine of the SS. Antonio e Biagio e Cesare Arrigo of Alessandria University Hospital, randomized into the control arm |
| Mediterranean-type diet with MCT supplementation | Experimental | Dietary Supplement: Mediterranean-type diet with MCT supplementationPatients with with first diagnosis of MCI referred to the S.C of Neurology and/or Geriatrics and/or Internal Medicine of the SS. Antonio e Biagio e Cesare Arrigo of Alessandria University Hospital, randomized into the experimental arm |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 85 years;
- Diagnosis of MCI;
- Disease duration of less than 24 months from symptom onset;
- Absence of malnutrition (diagnosed according to the NRS 2002 screening test) and with oral intakes sufficient to cover energy requirements (calculated by the Harris-Benedict formula, adjusted for activity factor and pathology);
- Ability to understand and sign informed consent.
Key exclusion criteria (18 listed)
- Patients on total or supplemental enteral nutrition
- Severe dysphagia
- Patients with glycated hemoglobin > 8%
- Patients on insulin therapy
- Patients with poor beta-cell function (e.g., pancreasectomy, acute and chronic pancreatitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean-type diet with MCT supplementationThe treatment arm will follow a Mediterranean diet supplemented by daily intake of MCT (30 mL) | Dietary supplement | Mediterranean-type diet with MCT supplementation |
| Mediterranean-type food regimen using extra virgin olive oilThe arm will follow a Mediterranean diet with an indication to take extra virgin olive oil as the main fat in the diet daily | Other | Mediterranean-type food regimen using extra virgin olive oil |
Primary outcome
Effect of medium-chain triglycerides (MCT) intake on cognitive impairment
Time frame: 6 months after baseline
Evaluate the effect of medium-chain triglycerides (MCT) intake on cognitive decline in patients with first diagnosis of MCI through the use of the Montreal Cognitive Assessment (MoCA), that includes a series of tests of visuospatial/executive functions, naming, attention, language, abstraction, delayed recall, and orientation for a total score of 30 (best cognitive status).
2 secondary outcomes
Positive effect of MCT intake on sleep quality
Time frame: Baseline and 6 months after baseline
Evaluation of quality of life
Time frame: Baseline, 3 months after baseline and 6 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean-type diet with MCT supplementation and Mediterranean-type food regimen using extra virgin olive oil in people with Mild Cognitive Impairment (MCI), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Luigi Mario Castello (0131206893, luigi.castello@ospedale.al.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of medium-chain triglycerides (MCT) intake on cognitive impairment (time frame: 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.