Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06951932

Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment

Led by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Updated on 2025-05-04

120

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

Sponsors

A

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Lead Sponsor

D

Dr. Schär AG / SPA

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years
  • Diagnosis of mild cognitive impairment (MCI)
  • Disease duration of less than 24 months from symptom onset
  • No malnutrition based on NRS 2002 screening and sufficient oral energy intake as per Harris-Benedict formula
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Use of total or supplemental enteral nutrition
  • Severe difficulty swallowing (dysphagia)
  • Glycated hemoglobin greater than 8%
  • Use of insulin therapy
  • Poor beta-cell function (e.g., pancreas removal, pancreatitis)
  • Liver failure with MELD score greater than 9
  • Malnutrition with oral intake less than 60% of energy requirements
  • Metabolic or enzyme disorders, dyslipidemia with cholesterol over 300 mg/dl or triglycerides over 400 mg/dl
  • Acute or recent (within 30 days) inflammatory or infectious disease
  • Untreated or inadequately treated thyroid disorders
  • Severe heart failure (NYHA III-IV), unstable angina, recent (less than 6 months) cardiovascular or cerebrovascular events
  • Pregnancy or breastfeeding
  • Neurological or psychiatric disorders other than MCI
  • Eating or nutrition disorders
  • Alcohol abuse
  • Institutionalized patients
  • Participation in experimental therapies within 2 months prior to enrollment
  • Allergy to MCT oil or nuts

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinical Trial Center

Alessandria, Piedmont, Italy, 15121

Actively Recruiting

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Research Team

P

Prof. Luigi Mario Castello

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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