RECRUITING

Essential Fats for Enhancing Cognitive Thinking (EFFECT) Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-07

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06223672

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.

Ages Eligible for Study:40 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subjective cognitive impairment * BMI ≥30 kg/m2 * HbA1C \<6.5%	* 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

Inclusion Criteria

Exclusion Criteria

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

* 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

Contacts and Locations

Study Contact

Martha Belury, PhD, RDN

CONTACT

614-292-1680

belury.1@osu.edu

Rachel Cole

CONTACT

614-247-8235

belurylabstudies@osu.edu

Principal Investigator

Martha Belury, PhD, RDN

PRINCIPAL_INVESTIGATOR

Ohio State University

Study Locations (Sites)

The Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University

Martha Belury, PhD, RDN, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-02-07

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2024-02-07

Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

Cognitive Decline
Cognitive Impairment