Clinical trial NCT06223672: Essential Fats for Enhancing Cognitive Thinking (EFFECT) Study
Official title: Essential Fats for Enhancing Cognitive Thinking (EFFECT) Study: Dietary Fat Quality and Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Decline
Cognitive Impairment
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
name: The California Walnut Commission
First posted: 2024-01-25
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
timeFrame: Week 0 and Week 5
Secondary outcomes:
measure: Change in Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
timeFrame: Week 0, Week 1, Week 5 and Week 6
measure: Changes in fecal Microbiota diversity
timeFrame: Week 0, Week 1, Week 5 and Week 6
Other outcomes:
measure: Changes in postprandial energy metabolism
timeFrame: Week 0 and Week 5
measure: Changes in postprandial respiratory quotient
timeFrame: Week 0 and Week 5
measure: Changes in postprandial lipids
timeFrame: Week 0 and Week 5
measure: Changes in postprandial Tumor necrosis factor levels
timeFrame: Week 0 and Week 5
measure: Changes in postprandial IL-6
timeFrame: Week 0 and Week 5
measure: Changes in postprandial C-Reactive Protein
timeFrame: Week 0 and Week 5
measure: Changes in postprandial Soluble intercellular adhesion molecule-1
timeFrame: Week 0 and Week 5
measure: Changes in cardiolipin species
timeFrame: Week 0, Week 1, Week 5 and Week 6
measure: Changes in postprandial glucose levels
timeFrame: Week 0 and Week 5
measure: Changes in postprandial insulin levels
timeFrame: Week 0 and Week 5
measure: Changes in postprandial cortisol levels
timeFrame: Week 0 and Week 5
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Martha Belury, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References: