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Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06223672
Acronym
EFFECT
Enrollment
88
Registered
2024-01-25
Start date
2024-02-07
Completion date
2026-12-31
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Cognitive Impairment

Brief summary

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

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.

Interventions

OTHERWalnuts

56g of walnuts consumed each day for 7 days

OTHERSimply White Diary-free chocolate bar

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

Sponsors

Ohio State University
Lead SponsorOTHER
United States Department of Agriculture (USDA)
CollaboratorFED
The California Walnut Commission
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

CONTACTMartha Belury, PhD, RDN
belury.1@osu.edu614-292-1680
CONTACTRachel Cole
belurylabstudies@osu.edu614-247-8235
PRINCIPAL_INVESTIGATORMartha Belury, PhD, RDN

Ohio State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026