WHolegrain and IMmunity study

Completed

Conditions: Cardiovascular health, gut health, inflammation
Circulatory System

Registration Number: ISRCTN36521837

Lead Sponsor: Cereal Partners Worldwide (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Healthy
2. Age 40-65y
3. Not on prescribed medication
4. Body mass index between 20 and 35
5. Low habitual consumption of wholegrain (<24g/d or 1.5 servings)

Exclusion Criteria

1. Diabetes, heart problems, stroke, vascular disease, inflammatory disease, renal/bowel/liver disease, pancreatitis
2. Any prescribed medication (including aspirin)
3. Asthma
4. Allergies
5. Smoking
6. Vegan
7. Eating out >3 times per week
8. On fish oil or other supplements
9. History of alcohol misuse
10. Consumption of alcohol of >21 units for men or >15 units for women
11. On weight-reducing diets
12. Intense aerobic exercise more than 3x per week
13. Participating in another clinical trial
12. Regular travel
13. Flu vaccination in previous 12 months or planned vaccination during next 12 months
14. Prebiotic or probiotics or antibiotics for 3 months prior

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Dietary intake assessed by questionnaire (daily during intervention)<br>2. Gut health assessed by questionnaire and microbiological analysis of stool samples (beginning and end of each arm of intervention)<br>3. Immune cell function (phagocytosis, natural killer cell activity, T cell activation) assessed by flow cytometry (beginning and end of each arm of intervention)

Secondary Outcome Measures

Name	Time	Method
1. Salivary IgA levels assessed by ELISA (beginning and end of each arm of intervention)<br>2. Blood lipids, glucose and insulin assessed by automatic analyser (beginning and end of each arm of intervention)<br>3. Plasma alkylresorcinols analysed by sponsor (beginning and end of each arm of intervention)<br>4. Inflammatory and metabolic markers analysed by Luminex (beginning and end of each arm of intervention)