Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjective cognitive impairment
BMI ≥30 kg/m2
HbA1C <6.5%
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Walnuts
Other intervention56g of walnuts consumed each day for 7 days
Simply White Diary-free chocolate bar
Other intervention68g of the white chocolate style-bar each day for 7 days
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: WalnutsExperimental treatment 1 intervention
Group B: White chocolate-style barExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Week 0 and Week 5Secondary outcomes
1
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
Time frame
Week 0, Week 1, Week 5 and Week 62
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
Time frame
Week 0, Week 1, Week 5 and Week 6Other outcomes
1
Changes in postprandial energy metabolism
To evaluate the effect of dietary fats on postprandial indirect calorimetry (kilocalories)
Time frame
Week 0 and Week 52
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
Time frame
Week 0 and Week 53
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)
Time frame
Week 0 and Week 54
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
Time frame
Week 0 and Week 5Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University
Lead sponsor
United States Department of Agriculture (USDA)
Collaborator
The California Walnut Commission
Collaborator
Source ClinicalTrials.gov