Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study

Cognitive Impairment Clinical Trial

— EFFECT  

Official title:

Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study: Dietary Fat Quality and Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06223672
• Other study ID #: 2023H0111
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: February 2024
• Source: Ohio State University
• Contact: Martha Belury, PhD, RDN
• Phone: 614-292-1680
• Email: belury.1[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	The California Walnut Commission, United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in postprandial energy metabolism	To evaluate the effect of dietary fats on postprandial indirect calorimetry (kilocalories)	Week 0 and Week 5
Other	Changes in postprandial respiratory quotient	To evaluate the effect of dietary fats on postprandial respiratory quotient to identify what fuels (carbohydrate protein or fat) are utilized	Week 0 and Week 5
Other	Changes in postprandial lipids	To evaluate the effect of dietary fats on postprandial lipid panel including total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides (mg/dL)	Week 0 and Week 5
Other	Changes in postprandial Tumor necrosis factor levels	To evaluate the effect of dietary fats on postprandial blood Tumor necrosis factor alpha (TNF), a marker of inflammation	Week 0 and Week 5
Other	Changes in postprandial IL-6	To evaluate the effect of dietary fats on postprandial blood IL-6 a marker of inflammation	Week 0 and Week 5
Other	Changes in postprandial C-Reactive Protein	To evaluate the effect of dietary fats on postprandial blood C-reactive protein, a marker of inflammation	Week 0 and Week 5
Other	Changes in postprandial Soluble intercellular adhesion molecule-1	To evaluate the effect of dietary fats on postprandial blood Soluble intercellular adhesion molecule-1, a marker of inflammation	Week 0 and Week 5
Other	Changes in cardiolipin species	To determine the impact of dietary fat on peripheral blood mononuclear cell cardiolipin species measured using electrospray ionization-mass spectrometry coupled to high-performance liquid chromatography	Week 0, Week 1, Week 5 and Week 6
Other	Changes in postprandial glucose levels	To determine the impact of dietary fat on postprandial blood glucose levels	Week 0 and Week 5
Other	Changes in postprandial insulin levels	To determine the impact of dietary fat on postprandial blood insulin levels	Week 0 and Week 5
Other	Changes in postprandial cortisol levels	To determine the impact of dietary fat on postprandial salivary cortisol levels	Week 0 and Week 5
Primary	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	Change in Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)	To assess changes in cognitive function after consuming 1 serving of the dietary fats every day for 1 week	Week 0, Week 1, Week 5 and Week 6
Secondary	Changes in fecal Microbiota diversity	To assess changes in microbiota diversity of fecal samples after consuming 1 serving of the dietary fats every day for 1 week	Week 0, Week 1, Week 5 and Week 6