Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study

The Ohio State University

Status: Enrolling

Conditions: Cognitive Impairment; Cognitive Decline

Treatments: Other: Simply White Diary-free chocolate bar; Other: Walnuts

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06223672

2023H0111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Walnuts

Experimental group

Description:

consumption of walnuts every day

Treatment:

Other: Walnuts

White chocolate-style bar

Experimental group

Description:

consumption of a white chocolate-style bar every day

Treatment:

Other: Simply White Diary-free chocolate bar