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Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments

NCT06444568 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-11-25

No results posted yet for this study

Summary

This clinical study aims to examine the effectiveness of a 12-week modified ketogenic diet (MKD) intervention, especially on cognitive functions, in individuals diagnosed with amnestic-mild cognitive impairment (aMCI) and to compare the effects of control groups (passive or active).

Accordingly, a sample of 36 older adults aged 65-80 years diagnosed with aMCI will be randomized into 3 different groups: passive control (without any intervention), active control (MIND: Mediterranean-DASH Intervention for Neurodegenerative Delay diet) or intervention (MKD). They will be monitored according to targeted criteria throughout the 12-week study protocol.

The main questions this study aims to answer are:

* Does a 12-week MKD intervention improve cognitive functions in aMCI?
* Does the effectiveness of the 12-week MKD intervention in aMCI (i.e., in terms of cognitive function, physical and functional measures, or metabolic/inflammatory biomarkers) differ from control groups?

Expected from participants during the study protocol:

* Participants assigned to the passive control arm are expected to come to the research center at the beginning (week 0) and end (week 12) of the protocol and participate in evaluations.
* Participants assigned to the active control (MIND diet) or intervention (MKD) arm are expected to adhere to assigned dietary therapy, keep a weekly food diary, and have weekly phone calls or online meetings with the dietitian to follow up on the diet. These participants assigned to the diet groups are expected to come to the research center at weeks 0, 4, 8, and 12 to participate in the evaluations.

Conditions

  • Amnestic Mild Cognitive Disorder
  • Amnestic Mild Cognitive Impairment

Interventions

OTHER

Dietary Intervention

The intervention includes the application and follow-up of different diet therapies to individuals (Ketogenic diet and MIND).

Sponsors & Collaborators

  • Ankara University

    collaborator OTHER

  • Saglik Bilimleri Universitesi

    lead OTHER

Principal Investigators

  • Mehmet I Naharcı, Prof. · Saglik Bilimleri University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2024-12-01
Completion
2025-03-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06444568 on ClinicalTrials.gov