Healthy volunteers Not Applicable
Conditions
Interventions
Participants (n = 100
50 young and 50 older adults) will take part in a chronic, double-blind, randomized, placebo-controlled, parallel-group trial. This study aims to assess whether dietary flavonoids affect the brain - a
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female 2. Aged between 18 to 40 years old OR above 65 years old
Exclusion criteria
Exclusion criteria: 1. Consumption of more than 21 units of alcohol per week 2. A history of cardiovascular, respiratory, metabolic, liver, inflammatory, or neurological diseases, including but not limited to hypertension (blood pressure >140/90 mmHg), diabetes mellitus, asthma, elevated cholesterol, anemia, immune conditions, and smoking 3. Use of prescribed or over-the-counter medications (except for oral contraception) 4. Allergies or intolerances to any ingredients in the dietary supplement 5. Currently following a weight-reducing dietary regimen 6. Use of any dietary supplements, including fatty acids and vitamins 7. Long-term medication use or use of antibiotics in the past 3 months 8. Current infection (e.g., cold) 9. Pregnancy or plans to become pregnant (for females of reproductive age)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prefrontal cortical concentrations of oxygenated and deoxygenated haemoglobin will be measured using broadband near-infrared spectroscopy (bNIRS) during rest and physiological stress (i.e., hypoxia simulated with 11% oxygen delivery) at the following time points: i) on day 1, before (0 hours) and 2 hours after supplementation with either low- or high-flavanol cocoa (acute effect); ii) on day 28 and day 56, before (0 hours) cocoa supplementation (chronic effect); and iii) on day 56, 2 hours after cocoa supplementation (acute within chronic effect). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prefrontal cortical neuronal mitochondrial activity (i.e., cytochrome c oxidase activity) measured using bNIRS during rest and physiological stress (i.e., hypoxia simulated with 11% oxygen delivery) at the following time points: i) on day 1, before (0 hours) and 2 hours after supplementation with either low- or high-flavanol cocoa (acute effect); ii) on day 28 and day 56, before (0 hours) cocoa supplementation (chronic effect); and iii) on day 56, 2 hours after cocoa supplementation (acute within chronic effect). 2. Prefrontal cortical levels of oxygenated and deoxygenated haemoglobin concentrations during cognitive performance measured using bNIRS at the following time points: i) on day 1, before (0 hours) and 2 hours after supplementation with either low- or high-flavanol cocoa (acute effect); ii) on day 56, before cocoa supplementation (chronic effect); and iii) on day 56, 2 hours after cocoa supplementation (acute within chronic effect). 3. Prefrontal cortical neuronal mitochondrial activity (i.e., cytochrome c oxidase activity) during cognitive performance measured using bNIRS at the following time points: i) on day 1, before (0 hours) and 2 hours after supplementation with either low- or high-flavanol cocoa (acute effect); ii) on day 56, before cocoa supplementation (chronic effect); and iii) on day 56, 2 hours after cocoa supplementation (acute within chronic effect). 4. Executive function accuracy and reaction time (indicator of cognitive performance) will be measured using the tasks listed below at the following time points: i) on day 1, before (0 hours) and 2 hours after supplementation with either low- or high-flavanol cocoa (acute effect); ii) on day 56, before cocoa supplementation (chronic effect); and iii) on day 56, 2 hours after cocoa supplementation (acute within chronic effect). 4.1. Modified Attention Network Task measures response to cognitive load 4.2. Switch Task considers cognitive flexibility with participants responding to stimuli accor | — |
Countries
England, United Kingdom
Contacts
Public ContactCatarina ;Jasmine Rendeiro;Yeh
;
Outcome results
None listed