Effects of wholegrain components on metabolic biomarkers: a four-week intervention study in 'at risk' subjects

Completed

Conditions: Chronic diseases, particularly cardiovascular disease and cancers
Not Applicable

Registration Number: ISRCTN93336504

Lead Sponsor: European Commission (Belgium)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Healthy men and women aged between 45 - 65 years
2. Body Mass Index (BMI) greater than 25 kg/m^2

This inclusion criteria were selected as such individuals are thought to be at a slightly greater risk of chronic disease.

Exclusion Criteria

1. Smokers
2. People on special diets (e.g. vegetarians, coeliac patients)
3. People with diabetes
4. Pre-existing chronic disease
5. Regular use of prescription medicine, including statins and blood pressure medication
6. People who regularly take any vitamin or mineral supplement or have done so in the last 6 months
7. Women who are pregnant or lactating
8. People who have given blood to the blood transfusion service (BTS) within the past 4 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in plasma homocysteine (a risk marker for CHD) attributable to treatment during the intervention, measured at baseline and 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Changes in other risk markers for disease attributable to treatments during the intervention:<br>1. Inflammatory markers and endothelial function<br>2. Antioxidant status<br>3. Lipid profile<br>4. Relevant micronutrient levels<br>5. Insulin and glucose levels<br><br>Outcomes measured at baseline and 4 weeks.