Cardiovascular health Circulatory System
Conditions
Interventions
Participants will first be asked to avoid wholegrain foods for 4 weeks. They will then be randomly allocated into one of two groups.
1. Participants will be provided with wholegrain br
Sponsors
Cereal Partners Worldwide (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 40-70 years 2. Generally healthy subjects, as determined by clinical examination and medical history 3. BMI between 25 and 35 kg/m2 4. Slightly elevated blood pressure after 5 minutes supine position (systolic blood pressure >120mmHg) 5. Mildly elevated plasma cholesterol (> 5.5mM) 6. Non smoking
Exclusion criteria
Exclusion criteria: 1. Known allergy to study (wheatbased) foods 2. History of metabolic disease (i.e.diabetes, cardiovascular disease) relevant for drug treatment 3. Chronic renal insufficiency 4. Local or general treatment (i.e. prescription medications, overthecounter medications, dietary supplements or herbal supplements) known to interfere with the evaluation of the studied parameters 5. Subject having had a general anaesthesia in the month preceding inclusion, or gastrointestinal surgery 6. Pregnant or breastfeeding subject 7. Use of laxatives 8. Known allergies to cereals 9. Dislike of provided study foods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Resting blood pressure, measured at screening visit and 0, 4, 6, 8, 12, 14, 16 weeks 2. 24 hour blood pressure, measured at screening visit and 0, 4, 8, 12, 16 weeks 3. Lipid profile, measured at screening visit and 0, 4, 8, 12, 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Metabolites of alkylresorcinols in urine as biomarkers of whole grain intake: 1.1. Venous blood samples for C17, C19, C21, C23, C24 alkylresorcinols at screening visit and 0, 4, 8, 12, 16 weeks 1.2. 24 hour urine and spot urine samples for 3,5 dihydroxybenzoic acid (DHBA) and 3,5-dihydroxyphenylpropionoic acid (DHPPA) at screening visit and 0, 4, 8, 12, 16 weeks 2. Plasma concentrations of alkylresorcinols as biomarkers for whole grain intake: 2.1. Venous blood samples at screening visit and 0, 4, 8, 12, 16 weeks 3. The impact on plasma biomarkers of CVD risk: 3.1. Intercellular adhesion molecule-1, vascular cell adhesion molecule-1, E-selectin at screening visit and 0, 4, 8, 12, 16 weeks 3.2. Anthropometric measures including weight, waist circumference, body composition and BMI 3.3. Anthropometric measurements: height (at screening visit only), weight, body mass index, body composition by bioelectrical impedance, waist and hip measurements at screening visit and 0, 4, 8, 12, 16 weeks 4. Diet acceptance: 4.1. Digestive health questionnaire at screening visit and 0, 4, 8, 12, 16 weeks 4.2. Food frequency questionnaire at screening visit and 0, 2, 4, 6, 8, 10, 12, 14, 16 weeks | — |
Countries
United Kingdom
Outcome results
None listed