Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments

NCT06444568 | Recruiting

• 1 other identifier: MKD001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• ADAS-Cog score

  Cognitive functions will be evaluated with the ADAS-Cog (Alzheimer's Disease Assessment Scale: Cognitive Subscale) test. This widely used test to assess global cognition, evaluates memory, language, praxis, and orientation with scores ranging from 0 (minimum) to 70 (maximum); increasing scores indicate poorer cognitive performance.

  Baseline (week:0) - end of the protocol (week:12)

Secondary Outcomes (9)

• Dual-task (Physical performance)

  Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)

• Handgrip strength (kg)

  Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)

• Total cholesterol (TC, mg/dL)

  Baseline (week:0) - end of the protocol (week:12)

• Low-density lipoprotein cholesterol (LDL-C, mg/dL)

  Baseline (week:0) - end of the protocol (week:12)

• High-density lipoprotein cholesterol (HDL-C, mg/dL)

  Baseline (week:0) - end of the protocol (week:12)

Other Outcomes (7)

• Geriatric Depression Scale-short form (GDS-15) score

  Baseline (week:0) - end of the protocol (week:12)

• Body weight (kg)

  Baseline (week:0) - week:4 - week:8 - end of the protocol (week:12)

• Body height (cm)

  Baseline (week:0)

Study Arms (3)

Passive control group

NO INTERVENTION

The passive control arm will not receive any intervention and will only be evaluated for primary outcome variables at the beginning (week: 0) and at the end (week: 12) of the protocol.

Active control group

ACTIVE COMPARATOR

MIND diet will be applied to participants assigned to the active control arm for 12 weeks. This group will be evaluated at visits (week: 0-4-8-12) in terms of primary and secondary outcome variables, in parallel with the intervention group (KD).

Other: Dietary Intervention

Intervention group (Modified ketogenic diet)

EXPERIMENTAL

The modified ketogenic diet (MKD) will be applied to participants assigned to the intervention arm for 12 weeks. This group will be evaluated for primary and secondary outcome variables at visits (weeks 0-4-8-12).

Other: Dietary Intervention

Interventions

Dietary Intervention OTHER

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

Active control group; Intervention group (Modified ketogenic diet)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Having been diagnosed with "amnestic mild cognitive impairment/disorder (aMCI)" by the clinician after the evaluation of cognitive functions according to the neuropsychological evaluation method (0.5 according to the Clinical Dementia Rating Scale (CDR).)
• Having at least 6 years of education.

You may not qualify if:

• Under the age of 65 or over the age of 80.
• Diagnosis of neurological (other than MCI) or psychological diseases.
• GDS-15 score \> 5 (baseline)
• Kidney/pancreas/liver diseases or dysfunctions, Type 1 diabetes (and Type II diabetic patients receiving insulin replacement therapy), cancer, metabolic diseases (fatty acid oxidation defect, etc.), thyroid dysfunction, pulmonary or autoimmune diseases, head trauma, history of any cardiovascular event (i.e., stroke, myocardial infarction) in the last year.
• Hypercholesterolemia (fasting T-C \>300 mg/dL or LDL-C \>200 mg/dL), non-reference B12 or folate levels according to biochemical tests performed in the last year.
• Nutritional risks (chewing/swallowing difficulties, history of involuntary weight loss in the last 6 months, body mass index \< 22 kg/m2).
• Use of internal device/implant (pacemaker or hearing aid, etc.).
• Medication use (individuals using anticholinergic, antidementia, and opioid class drugs will be excluded; individuals using antidepressant class drugs will be included in the study on the condition that it has been continued for at least 3 months and there is no change in drug type and dose during the study protocol.)

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Ankara University: collaborator

Study Sites (1)

Gulhane Faculty of Medicine & Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Neth BJ, Mintz A, Whitlow C, Jung Y, Solingapuram Sai K, Register TC, Kellar D, Lockhart SN, Hoscheidt S, Maldjian J, Heslegrave AJ, Blennow K, Cunnane SC, Castellano CA, Zetterberg H, Craft S. Modified ketogenic diet is associated with improved cerebrospinal fluid biomarker profile, cerebral perfusion, and cerebral ketone body uptake in older adults at risk for Alzheimer's disease: a pilot study. Neurobiol Aging. 2020 Feb;86:54-63. doi: 10.1016/j.neurobiolaging.2019.09.015. Epub 2019 Sep 26.

  PMID: 31757576 BACKGROUND

• Phillips MCL, Deprez LM, Mortimer GMN, Murtagh DKJ, McCoy S, Mylchreest R, Gilbertson LJ, Clark KM, Simpson PV, McManus EJ, Oh JE, Yadavaraj S, King VM, Pillai A, Romero-Ferrando B, Brinkhuis M, Copeland BM, Samad S, Liao S, Schepel JAC. Randomized crossover trial of a modified ketogenic diet in Alzheimer's disease. Alzheimers Res Ther. 2021 Feb 23;13(1):51. doi: 10.1186/s13195-021-00783-x.

  PMID: 33622392 BACKGROUND

• Liu X, Morris MC, Dhana K, Ventrelle J, Johnson K, Bishop L, Hollings CS, Boulin A, Laranjo N, Stubbs BJ, Reilly X, Carey VJ, Wang Y, Furtado JD, Marcovina SM, Tangney C, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline. Contemp Clin Trials. 2021 Mar;102:106270. doi: 10.1016/j.cct.2021.106270. Epub 2021 Jan 9.

  PMID: 33434704 BACKGROUND

• de Crom TOE, Mooldijk SS, Ikram MK, Ikram MA, Voortman T. MIND diet and the risk of dementia: a population-based study. Alzheimers Res Ther. 2022 Jan 12;14(1):8. doi: 10.1186/s13195-022-00957-1.

  PMID: 35022067 BACKGROUND

• Kheirouri S, Alizadeh M. MIND diet and cognitive performance in older adults: a systematic review. Crit Rev Food Sci Nutr. 2022;62(29):8059-8077. doi: 10.1080/10408398.2021.1925220. Epub 2021 May 14.

  PMID: 33989093 BACKGROUND

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Mehmet I Naharcı, Prof.

  Saglik Bilimleri University

  STUDY CHAIR

Central Study Contacts

Mehmet I Naharcı, Prof.

CONTACT

(+90)3123812350/6578; drnaharci@yahoo.com

Hilal Şimşek

CONTACT

hllsimsek@ankara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 5, 2024
• Study Start: May 20, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)