NCT06705738

The Effect of Combination of Mediterranean Diet and Oleocanthal in Patients with Mild Cognitive Impairment

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

BACKGROUND: Mild cognitive impairment (MCI) constitutes a form of preclinical dementia and characterizes a cognitive decline that exceeds what is expected for one's age and education status, but at the same time does not fulfill the criteria for dementia. MCI is considered a prodromal stage of Alzheimer's disease (AD) and the progression to this neurodegenerative disease, renders the patients heavily dependent on their relatives and the society, which creates a huge psychological and financial burden, since no effective treatment exists for MCI and AD to this day. Mediterranean diet (MeDi) displays beneficial effects on the cognitive function of both healthy individuals and cognitive impaired patients. High Phenolic Early Harvest Extra Virgin Olive Oil (HP-EH-EVOO) is a natural product that contains high concentrations of the substance Oleocanthal (OLC), while at the same time it has been shown to exert beneficial properties on the cognitive function of cognitive impaired individuals, as well as on the slowing down of the decline of cognitive function. AIM: The main hypothesis that will be evaluated is whether the combined approach of the MeDi pattern and the concurrent intervention with the administration in a capsule form of the supplement containing olive oil polyphenols with the main substance being Oleocanthal (SUPOL), could constitute a considerable strategy of management of MCI patients. Study Type: Investigational Study Design, Allocantion: Randomized Intervention Model, Parallel Assignment Masking: Single Blind (Outcome Assessor - Investigator) on Diet, Double Blind (Subject, Outcome Assessor - Investigator) on Supplement, Primary Purpose: Prevention.

Detailed description

OBJECTIVE OF THE TRIAL: To evaluate the efficacy of the combined approach of the MeDi pattern and the concurrent SUPOL compared to the Western diet pattern in combination with placebo on the change in cognition and function in subjects with MCI. STUDY DESIGN: The design will be a randomized parallel controlled clinical trial, single-blinded for the dietary pattern and double-blinded for the intervention. PARTICIPANTS: They will be divided into 4 groups of 50 (n=200): 1st group following MeDi and receiving SUPOL, 2nd group following MeDi and receiving Placebo, 3rd group following Western type diet (Western diet) and receiving SUPOL and 4th group following Western diet and receiving Placebo. DURATION: The duration of the combined intervention will be 12 months and the neuropsychological and laboratory evaluation of the participants will take place at baseline and upon the completion of the 1-year combined intervention. A follow-up assessment visit will be perfomed after 6 monts. The total study duration will be 18 months. LOCATION: The study will be conducted in Thessaloniki and will recruit patients having diagnosed with MCI from the outpatient clinic 1st Neurological Clinic of the General University Hospital "AHEPA" (AHEPA) and the Greek Association of Alzheimer's Disease and Related Disorders (Alzheimer Hellas). SCREENING - RANDOMIZATION - BASELINE (Visit 1): Patient eligibility will be determined during Visit 1. A protocol eligibility form will be completed for each patient and reviewed by the Principal Investigator (PI) approval prior to participation in the study. If eligibility is reached, baseline assessments, as well as randomization for group allocation will take place.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SUPOL	Supplement containing Olive Oil Polyphenol with the main substance being Oleocanthal (SUPOL), 2 capsules twice a day (4 capsules total) for 12 months.
OTHER	Dietary Pattern: MeDi	Adherance to Mediterranean dietary pattern to be followed for 12 months.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-04-30
• Completion: 2026-11-01
• First posted: 2024-11-26
• Last updated: 2024-11-26

Locations

2 sites across 1 country: Greece