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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN93336504
Enrollment
80
Registered
2008-12-04
Start date
2007-12-15
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic diseases, particularly cardiovascular disease and cancers Not Applicable

Interventions

Volunteers were stratified by age and sex and randomly assigned into the test or control group: 1. Test group: 3 x high-bran products per day for 4 weeks (1 x ready-to-eat cereal + 2 x bread products)

Sponsors

European Commission (Belgium)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026