Essential Fats for Enhancing Cognitive Thinking (EFFECT) Study

Not Applicable

Recruiting

• Conditions: Cognitive Impairment; Cognitive Decline
• Interventions: Other: Walnuts; Other: Simply White Diary-free chocolate bar

• Registration Number: NCT06223672
• Lead Sponsor: Ohio State University

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.

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.

Study Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Study Start: 2024-02-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-27
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Walnuts	Walnuts	consumption of walnuts every day
White chocolate-style bar	Simply White Diary-free chocolate bar	consumption of a white chocolate-style bar every day

Primary Outcome Measures

Name	Time	Method
Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)	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 Outcome Measures

Name	Time	Method
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	To assess changes in cognitive function after consuming 1 serving of the dietary fats every day for 1 week
Changes in fecal Microbiota diversity	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

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States