Recruiting

Essential Fats

Sponsor:

Ohio State University

Code:

NCT06223672

Conditions

Cognitive Decline

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Walnuts

Simply White Diary-free chocolate bar

Study Details

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.

Conditions

Cognitive Decline

Cognitive Impairment

Study ID

NCT06223672

Start date

Feb 7, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Walnuts

consumption of walnuts every day

experimental: White chocolate-style bar

consumption of a white chocolate-style bar every day

Interventions

Walnuts

56g of walnuts consumed each day for 7 days

Simply White Diary-free chocolate bar

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Martha Belury, PhD, RDN

614-292-1680belury.1@osu.edu

Rachel Cole

614-247-8235belurylabstudies@osu.edu

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Martha Belury, PhD

614-292-1680belury.1@osu.edu

More Information

Sponsor

Ohio State University

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-04-21.