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Recruiting NCT06223672

Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study

No phase Interventional Cognitive Decline Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Walnuts, Simply White Diary-free chocolate bar.
Who it may be relevant to
Registry conditions: Cognitive Decline, Cognitive Impairment. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Walnuts
    56g of walnuts consumed each day for 7 days
  • Other Simply White Diary-free chocolate bar
    68g of the white chocolate style-bar each day for 7 days

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]
  • Changes in fecal Microbiota diversity [Time frame: Week 0, Week 1, Week 5 and Week 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Ohio State University — Columbus

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. PMID 41418290

Identifiers

NCT: NCT06223672 · 2023H0111

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗