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NCT Number: NCT06223672

Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Martha Belury, PhD

CONTACT

[email protected]

614-292-1680

About this study

Study objective including

  • To measure the impact of dietary fats on postprandial cognitive function in adults who report subjective cognitive complaints.
  • To assess the effect of dietary fat consumption on the gut-brain axis in relationship to cognitive function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walnuts

Other

56g of walnuts consumed each day for 7 days

Simply White Diary-free chocolate bar

Other

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

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)

    Time frame: Week 0 and Week 5

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

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)

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

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

  2. Changes in fecal Microbiota diversity

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

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

Other outcomes

  1. Changes in postprandial energy metabolism

    Time frame: Week 0 and Week 5

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

  2. Changes in postprandial respiratory quotient

    Time frame: Week 0 and Week 5

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

  3. Changes in postprandial lipids

    Time frame: Week 0 and Week 5

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

  4. Changes in postprandial Tumor necrosis factor levels

    Time frame: Week 0 and Week 5

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

  5. Changes in postprandial IL-6

    Time frame: Week 0 and Week 5

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

  6. Changes in postprandial C-Reactive Protein

    Time frame: Week 0 and Week 5

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

  7. Changes in postprandial Soluble intercellular adhesion molecule-1

    Time frame: Week 0 and Week 5

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

  8. Changes in cardiolipin species

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

    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

  9. Changes in postprandial glucose levels

    Time frame: Week 0 and Week 5

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

  10. Changes in postprandial insulin levels

    Time frame: Week 0 and Week 5

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

  11. Changes in postprandial cortisol levels

    Time frame: Week 0 and Week 5

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

Study contacts

Contact information is provided by the study sponsor or research team.

Martha Belury, PhD, RDN

CONTACT

[email protected]

614-292-1680

Rachel Cole

CONTACT

[email protected]

614-247-8235

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • The California Walnut Commission
  • United States Department of Agriculture (USDA)

Registry information

Official study title

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

Acronym: EFFECT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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