The CocoaClarity study: shedding light on the direct vs indirect mechanisms of action of dietary flavonoids in the human brain
Not Applicable
- Conditions
- Healthy volunteersNot Applicable
- Registration Number
- ISRCTN29176549
- Lead Sponsor
- University of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Healthy male or female2. Aged between 18 to 40 years old OR above 65 years old
Exclusion Criteria
- Consumption of more than 21 units of alcohol per week2. 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 smoking3. Use of prescribed or over-the-counter medications (except for oral contraception)4. Allergies or intolerances to any ingredients in the dietary supplement5. Currently following a weight-reducing dietary regimen6. Use of any dietary supplements, including fatty acids and vitamins7. Long-term medication use or use of antibiotics in the past 3 months8. Current infection (e.g., cold)9. Pregnancy or plans to become pregnant (for females of reproductive age)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method