Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study (EFFECT)

February 9, 2024 updated by: Martha Belury, Ohio State University

Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study: Dietary Fat Quality and Cognitive Impairment

The proposed research is a randomized crossover trial designed to assess changes in postprandial cognitive function and the gut-brain axis in adults with subjective cognitive complaints who consume 1 study snack per day for 1 week.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study objective including

  1. To measure the impact of dietary fats on postprandial cognitive function in adults who report subjective cognitive complaints.
  2. To assess the effect of dietary fat consumption on the gut-brain axis in relationship to cognitive function.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Martha Belury, PhD, RDN
  • Phone Number: 614-292-1680
  • Email: belury.1@osu.edu

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjective cognitive impairment
  • BMI ≥30 kg/m2
  • HbA1C <6.5%

Exclusion Criteria:

  • Diagnosis og cognitive impairment or dementia
  • Montreal Cognitive Assessment (MoCA) score of <26
  • Current or previous diagnosis of Diabetes or use of diabetes medications
  • Current diagnosis of or current treatment of cancer other than non-melanoma skin cancer
  • Gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) where consumption of the study foods would be contraindication or where the disease or disorder could negatively affect nutrient absorption and/or would prevent participants from tolerating the study foods
  • Hyperthyroidism diagnosis
  • Food Allergy or intolerances
  • Any dietary restriction where consumption of the study foods, study meals/snack or meal challenge or any ingredient would be contraindicated
  • Use of some oil supplements in the past 4 weeks prior to enrolling
  • Pregnancy and lactation
  • Inability to access veins for venipuncture
  • Antibiotic use in the past month
  • Psychostimulant or nootropic medication use
  • Current use of supplements or medications for weight loss or following a weight loss program
  • Severe or uncontrolled autoimmune diseases
  • Current or previous diagnosis of severe kidney failure, liver cirrhosis and some pulmonary diseases
  • Heart disease events (including stroke or heart attack) within last 3 months prior to enrollment
  • Alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Walnuts
consumption of walnuts every day
Other: Walnuts
56g of walnuts consumed each day for 7 days
Experimental: White chocolate-style bar
consumption of a white chocolate-style bar every day
Other: Simply White Diary-free chocolate bar
68g of the white chocolate style-bar each day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
Time Frame: Week 0 and Week 5
To determine the impact of consuming the study dietary fats as part of a high fat meal on postprandial cognitive function
Week 0 and Week 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
Time Frame: Week 0, Week 1, Week 5 and Week 6
To assess changes in cognitive function after consuming 1 serving of the dietary fats every day for 1 week
Week 0, Week 1, Week 5 and Week 6
Changes in fecal Microbiota diversity
Time Frame: Week 0, Week 1, Week 5 and Week 6
To assess changes in microbiota diversity of fecal samples after consuming 1 serving of the dietary fats every day for 1 week
Week 0, Week 1, Week 5 and Week 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in postprandial energy metabolism
Time Frame: Week 0 and Week 5
To evaluate the effect of dietary fats on postprandial indirect calorimetry (kilocalories)
Week 0 and Week 5
Changes in postprandial respiratory quotient
Time Frame: Week 0 and Week 5
To evaluate the effect of dietary fats on postprandial respiratory quotient to identify what fuels (carbohydrate protein or fat) are utilized
Week 0 and Week 5
Changes in postprandial lipids
Time Frame: Week 0 and Week 5
To evaluate the effect of dietary fats on postprandial lipid panel including total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides (mg/dL)
Week 0 and Week 5
Changes in postprandial Tumor necrosis factor levels
Time Frame: Week 0 and Week 5
To evaluate the effect of dietary fats on postprandial blood Tumor necrosis factor alpha (TNF), a marker of inflammation
Week 0 and Week 5
Changes in postprandial IL-6
Time Frame: Week 0 and Week 5
To evaluate the effect of dietary fats on postprandial blood IL-6 a marker of inflammation
Week 0 and Week 5
Changes in postprandial C-Reactive Protein
Time Frame: Week 0 and Week 5
To evaluate the effect of dietary fats on postprandial blood C-reactive protein, a marker of inflammation
Week 0 and Week 5
Changes in postprandial Soluble intercellular adhesion molecule-1
Time Frame: Week 0 and Week 5
To evaluate the effect of dietary fats on postprandial blood Soluble intercellular adhesion molecule-1, a marker of inflammation
Week 0 and Week 5
Changes in cardiolipin species
Time Frame: Week 0, Week 1, Week 5 and Week 6
To determine the impact of dietary fat on peripheral blood mononuclear cell cardiolipin species measured using electrospray ionization-mass spectrometry coupled to high-performance liquid chromatography
Week 0, Week 1, Week 5 and Week 6
Changes in postprandial glucose levels
Time Frame: Week 0 and Week 5
To determine the impact of dietary fat on postprandial blood glucose levels
Week 0 and Week 5
Changes in postprandial insulin levels
Time Frame: Week 0 and Week 5
To determine the impact of dietary fat on postprandial blood insulin levels
Week 0 and Week 5
Changes in postprandial cortisol levels
Time Frame: Week 0 and Week 5
To determine the impact of dietary fat on postprandial salivary cortisol levels
Week 0 and Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

United States Department of Agriculture (USDA)
The California Walnut Commission

Investigators

  • Principal Investigator: Martha Belury, PhD, RDN, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023H0111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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