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RecruitingNCT06223672EFFECTUpdated Apr 21, 2026

Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study

An interventional study of Walnuts and Simply White Diary-free chocolate bar in Cognitive Decline and Cognitive Impairment, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Ohio State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Cognitive Decline
  • Cognitive Impairment
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 88 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    Walnuts

    consumption of walnuts every day

    Other: Walnuts

  • Experimental
    White chocolate-style bar

    consumption of a white chocolate-style bar every day

    Other: Simply White Diary-free chocolate bar

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

06

What researchers measure

Primary outcomes

  1. Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)

    To determine the impact of consuming the study dietary fats as part of a high fat meal on postprandial cognitive function

    Time frame: Week 0 and Week 5

Secondary outcomes

  1. Change in Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)

    To assess changes in cognitive function after consuming 1 serving of the dietary fats every day for 1 week

    Time frame: Week 0, Week 1, Week 5 and Week 6

  2. Changes in fecal Microbiota diversity

    To assess changes in microbiota diversity of fecal samples after consuming 1 serving of the dietary fats every day for 1 week

    Time frame: Week 0, Week 1, Week 5 and Week 6

Other outcomes

  1. Changes in postprandial energy metabolism

    To evaluate the effect of dietary fats on postprandial indirect calorimetry (kilocalories)

    Time frame: Week 0 and Week 5

  2. Changes in postprandial respiratory quotient

    To evaluate the effect of dietary fats on postprandial respiratory quotient to identify what fuels (carbohydrate protein or fat) are utilized

    Time frame: Week 0 and Week 5

  3. Changes in postprandial lipids

    To evaluate the effect of dietary fats on postprandial lipid panel including total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides (mg/dL)

    Time frame: Week 0 and Week 5

  4. Changes in postprandial Tumor necrosis factor levels

    To evaluate the effect of dietary fats on postprandial blood Tumor necrosis factor alpha (TNF), a marker of inflammation

    Time frame: Week 0 and Week 5

  5. Changes in postprandial IL-6

    To evaluate the effect of dietary fats on postprandial blood IL-6 a marker of inflammation

    Time frame: Week 0 and Week 5

  6. Changes in postprandial C-Reactive Protein

    To evaluate the effect of dietary fats on postprandial blood C-reactive protein, a marker of inflammation

    Time frame: Week 0 and Week 5

  7. Changes in postprandial Soluble intercellular adhesion molecule-1

    To evaluate the effect of dietary fats on postprandial blood Soluble intercellular adhesion molecule-1, a marker of inflammation

    Time frame: Week 0 and Week 5

  8. Changes in cardiolipin species

    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

    Time frame: Week 0, Week 1, Week 5 and Week 6

  9. Changes in postprandial glucose levels

    To determine the impact of dietary fat on postprandial blood glucose levels

    Time frame: Week 0 and Week 5

  10. Changes in postprandial insulin levels

    To determine the impact of dietary fat on postprandial blood insulin levels

    Time frame: Week 0 and Week 5

  11. Changes in postprandial cortisol levels

    To determine the impact of dietary fat on postprandial salivary cortisol levels

    Time frame: Week 0 and Week 5

07

Study locations

1 of 1 sites recruiting
  • The Ohio State University
    Columbus, Ohio 43210, United States
    Recruiting
08

References and documents

Publications

  • Zarich S, Cole RM, Fairchild K, Spakowicz D, Sparagna G, Madison A, Ni A, Belury MA. Effects of Walnuts on Postprandial Cognitive Function in Adults With Subjective Cognitive Impairment: Protocol for a Randomized Crossover Trial. JMIR Res Protoc. 2025 Dec 19;14:e82032. doi: 10.2196/82032. PubMed 41418290 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06223672
Lead sponsor
Ohio State University
Collaborators
United States Department of Agriculture (USDA), The California Walnut Commission
Responsible party
Martha Belury (Professor and Chair, Food Science and Technology, Ohio State University) — Principal investigator
First posted
Jan 25, 2024
Start date
Feb 7, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 21, 2026

Study contacts

Martha Belury, PhD, RDN
Contact
belury.1@osu.edu
614-292-1680
Rachel Cole
Contact
belurylabstudies@osu.edu
614-247-8235
Martha Belury, PhD, RDN
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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