Nutrition Interventions for Cognitive Enhancement

NCT03841539 | Completed

• 2 other identifiers: STUDY001427521R01AG060157-01
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

By doing this study, researchers hope to learn how the Mediterranean and low-fat eating patterns affect memory, brain volume, brain antioxidant status and cardio-metabolic biomarkers, such as blood pressure and blood glucose, in cognitively normal older adults. Researchers also plan to examine underlying processes relating the patterns to brain health.

Conditions

Alzheimer Disease

Keywords

Cognitive Impairment; Dementia; Alzheimer Disease; Mediterranean Diet; Low Fat Diet

Outcome Measures

Primary Outcomes (1)

• Change in a composite global cognition score

  Alzheimer's Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite (ADCS-PACC) and NIH Toolbox (NIH-TB) Cognition Battery and will be used to assess changes in a composite global cognition score at baseline, 6, and 12 months.

  Baseline, 6 months and 12 months

Secondary Outcomes (29)

• Change in Verbal Memory Factor

  Baseline, 6 months and 12 months

• Change in Visuospatial Processing Factor

  Baseline, 6 months and 12 months

• Change in Attention Factor

  Baseline, 6 months and 12 months

• Change in Executive Function Factor

  Baseline, 6 months and 12 months

• Change in Speed of Processing Factor

  Baseline, 6 months and 12 months

Study Arms (2)

Mediterranean Diet

EXPERIMENTAL

Follow a Mediterranean eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian.

Behavioral: Mediterranean Diet; Dietary Supplement: Study Supplement

Low-fat Diet

ACTIVE COMPARATOR

Follow a low-fat eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian.

Dietary Supplement: Study Supplement; Behavioral: Low-fat Diet

Interventions

Mediterranean Diet BEHAVIORAL

Diet consisting of fruits, vegetables, whole grains, low-fat dairy, olive oil, seafood, nuts and beans. It is low in red and processed meats, solid fats and added sugars.

Mediterranean Diet

Study Supplement DIETARY_SUPPLEMENT

Randomized to take a daily dose of either 2 grams of Omega 3 fatty acids or 2 grams of a Placebo.

Low-fat Diet; Mediterranean Diet

Low-fat Diet BEHAVIORAL

Diet consisting of fruits, vegetables, whole grains, low-fat dairy, and low-fat protein, with fat contributing no more than 25% of calories.

Low-fat Diet

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Cognitively normal older adults ≥65 years (MMSE score ≥ 25; AD8 score of 2 or less; no prior diagnosis of MCI, AD or dementia; and not medically treated for cognitive impairment or dementia)
• Speak English as a primary language
• Be able to read and write in English
• Live in the Kansas City, Metropolitan area
• Body Mass Index (BMI) range between 20 - 40 kg/m2

You may not qualify if:

• Serious medical risk, such as type 1 diabetes mellitus, cancer, recent cardiac event (e.g. heart attach, angioplasty)
• Taking the prescription drug Warfarin
• Taking a prescription fish oil, such as Lovaza, Omtryga, Vascepa, Epanova, etc., or prescribed a dose of over-the-counter (OTC) fish oil containing ≥300 mg Docohexanoic Acid (DHA) that cannot be adjusted to a lower dose
• Nut allergy, fish allergy (does not include shellfish)
• Adherence to specialized diet regimes (e.g., vegan, bariatric, renal, etc.) that make following either of the dietary plans impossible or unsafe
• Unwilling to be randomized to one of two diet interventions
• Evidence of severe major depression (GDS-SF ≥9) or presence of a major psychiatric disorder that in the investigator's opinion, could interfere with adherence to research assessments or procedures
• Alcohol (over 3 drinks per day or total of 18 per week) or drug abuse, defined as the use of chemical substances (prescription, OTC or illegal drugs) in a pattern that can lead to an increased risk of problems and an inability to control the use of the substance
• Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, retirement community with reliance on dining facilities for meals)
• Already consuming a Mediterranean diet as determined using the 14-item MedD Assessment Tool (score of ≥8)
• Already consuming a low-fat diet as determined by the NCI Percentage Energy from Fat Screener (≤ 15% of calories from fat)
• Already participating in another research study
• Another member of household is already participating in this study
• Have a visual impairment that greatly diminishes ability to read or write
• Currently attempting to lose weight

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Interventions

Diet, Mediterranean; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Debra K Sullivan, PhD, RD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Raters - (psychometrician, brain magnetic resonance imaging (MRI), dual energy x-ray absorptiometry (DEXA), and phlebotomy) will be blinded to the intervention group and will perform outcome assessments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Endowed Professor of Clinical Nutrition

Model Details: Participants will be randomized to a dietary intervention; Mediterranean or Low-Fat, and will follow this eating pattern for 12 months.

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: February 15, 2019
• Study Start: March 7, 2019
• Primary Completion: March 15, 2023
• Study Completion: March 22, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)