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Recruiting Not applicable NCT06223672

Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study

No applicable phase (e.g. observational)
Conditions: Cognitive Decline Cognitive Impairment

Sponsor: Ohio State University

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Walnuts
OTHER
Simply White Diary-free chocolate bar
OTHER
Locations 1
United States (1)
The Ohio State University
Columbus , Ohio
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
07.02.2024
Completion date
31.12.2026
Registry ID
NCT06223672
Source
clinicaltrials.gov
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