Cognitive Decline, Cognitive Impairment
Conditions
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.
Interventions
OTHERWalnuts
56g of walnuts consumed each day for 7 days
OTHERSimply White Diary-free chocolate bar
68g of the white chocolate style-bar each day for 7 days
Sponsors
United States Department of Agriculture (USDA)
The California Walnut Commission
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in postprandial Tumor necrosis factor levels | Week 0 and Week 5 | To evaluate the effect of dietary fats on postprandial blood Tumor necrosis factor alpha (TNF), a marker of inflammation |
| Changes in postprandial IL-6 | Week 0 and Week 5 | To evaluate the effect of dietary fats on postprandial blood IL-6 a marker of inflammation |
| Changes in postprandial C-Reactive Protein | Week 0 and Week 5 | To evaluate the effect of dietary fats on postprandial blood C-reactive protein, a marker of inflammation |
| Changes in postprandial Soluble intercellular adhesion molecule-1 | Week 0 and Week 5 | To evaluate the effect of dietary fats on postprandial blood Soluble intercellular adhesion molecule-1, a marker of inflammation |
| Changes in postprandial energy metabolism | Week 0 and Week 5 | To evaluate the effect of dietary fats on postprandial indirect calorimetry (kilocalories) |
| Changes in postprandial glucose levels | Week 0 and Week 5 | To determine the impact of dietary fat on postprandial blood glucose levels |
| Changes in postprandial insulin levels | Week 0 and Week 5 | To determine the impact of dietary fat on postprandial blood insulin levels |
| Changes in postprandial cortisol levels | Week 0 and Week 5 | To determine the impact of dietary fat on postprandial salivary cortisol levels |
| Changes in cardiolipin species | Week 0, Week 1, Week 5 and Week 6 | 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 |
| Changes in postprandial respiratory quotient | Week 0 and Week 5 | To evaluate the effect of dietary fats on postprandial respiratory quotient to identify what fuels (carbohydrate protein or fat) are utilized |
| Changes in postprandial lipids | Week 0 and Week 5 | To evaluate the effect of dietary fats on postprandial lipid panel including total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides (mg/dL) |
Countries
United States
Contacts
Primary ContactMartha Belury, PhD, RDN
Backup ContactRachel Cole
Outcome results
None listed