Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study

NCT ID: NCT06223672

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognitive Decline Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Walnuts

consumption of walnuts every day

Group Type EXPERIMENTAL

Walnuts

Intervention Type OTHER

56g of walnuts consumed each day for 7 days

White chocolate-style bar

consumption of a white chocolate-style bar every day

Group Type EXPERIMENTAL

Simply White Diary-free chocolate bar

Intervention Type OTHER

68g of the white chocolate style-bar each day for 7 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Walnuts

56g of walnuts consumed each day for 7 days

Intervention Type OTHER

Simply White Diary-free chocolate bar

68g of the white chocolate style-bar each day for 7 days

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

United States Department of Agriculture (USDA)

FED

Sponsor Role collaborator

The California Walnut Commission

UNKNOWN

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Martha Belury

Professor and Chair, Food Science and Technology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martha Belury, PhD, RDN

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Martha Belury, PhD, RDN

Role: CONTACT

614-292-1680

Rachel Cole

Role: CONTACT

614-247-8235

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Martha Belury, PhD

Role: primary

614-292-1680

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023H0111

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

How Fat Influences the Brain
NCT01516021 COMPLETED NA
Soy and Brain Vascular Function
NCT03627637 COMPLETED NA
Oil Consumption and Cholesterol
NCT04397055 COMPLETED NA
Food Effects on the Gut Microbiota
NCT03078283 COMPLETED NA
Effects of Meal Macronutrients on Postprandial Lipids
NCT07313787 NOT_YET_RECRUITING PHASE2