NCT06223672

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Feb 2024Dec 2026

First Submitted

Initial submission to the registry

October 9, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

February 7, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

October 9, 2023

Last Update Submit

April 16, 2026

Conditions

Cognitive DeclineCognitive Impairment

Outcome Measures

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

    Week 0 and Week 5

Secondary Outcomes (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)

    Week 0, Week 1, Week 5 and Week 6

  • Changes in fecal Microbiota diversity

    Week 0, Week 1, Week 5 and Week 6

Other Outcomes (11)

  • Changes in postprandial energy metabolism

    Week 0 and Week 5

  • Changes in postprandial respiratory quotient

    Week 0 and Week 5

  • Changes in postprandial lipids

    Week 0 and Week 5

  • +8 more other outcomes

Study Arms (2)

Walnuts

EXPERIMENTAL

consumption of walnuts every day

Other: Walnuts

White chocolate-style bar

EXPERIMENTAL

consumption of a white chocolate-style bar every day

Other: Simply White Diary-free chocolate bar

Interventions

WalnutsOTHER

56g of walnuts consumed each day for 7 days

Walnuts
Simply White Diary-free chocolate barOTHER

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

White chocolate-style bar

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (1)

  • 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: 41418290DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Martha Belury, PhD, RDN

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha Belury, PhD, RDN

CONTACT

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

Rachel Cole

CONTACT

614-247-8235belurylabstudies@osu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair, Food Science and Technology

Study Record Dates

First Submitted

October 9, 2023

First Posted

January 25, 2024

Study Start

February 7, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

US(1)