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RECRUITING
NCT06444568
NA

Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments

Sponsor: Saglik Bilimleri Universitesi

View on ClinicalTrials.gov

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.

Official title: Efficacy of Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments

Key Details

Gender

All

Age Range

65 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-05-20

Completion Date

2025-03-01

Last Updated

2024-11-25

Healthy Volunteers

No

Interventions

OTHER

Dietary Intervention

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

Locations (1)

Gulhane Faculty of Medicine & Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)