Breakfast Intervention Study
- Conditions
- Risk factors for cardiovascular disease such as hypertension and hypercholesterolemia in subjects with at least one clinical feature of the metabolic syndrome.Cardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12607000158460
- Lead Sponsor
- niversity of Western Australia, School of Medicine and Pharmacology.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
With at least one clinical feature of the metabolic syndrome as defined by the American Heart Association.
Exclusion Criteria
1.Use of pure vitamin E supplements. 2.Gastrointestinal disorders. 3.Used antibiotics 4 weeks prior to the study. 4.Alcohol intake >40g/day men 30g/day women. 5.Pre and perimenopausal women. 6.Smoking. 7.Recent coronary/cerebrovascular event <6months. Evidence of renal impairment. 8.Body Mass Index >35. 9.Use of lipid or hypertensive medications. 10. Diabetes requiring insulin. 11. Episodic use of non-steroidal anti-inflammatory medication. 12. History of heart failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Blood cholesterol levels.[Measured at baseline (at the beginning of the study and also at the end of week 9, i.e. after the wash out period) and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14)];2. Blood pressure (ambulatory blood pressure monitoring).[Measured at baseline (at the beginning of the study and also at the end of week 9, i.e. after the wash out period) and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14)];3.Serum vitamin E and mammalian lignan levels.[Measured at baseline (at the beginning of the study and also at the end of week 9, i.e. after the wash out period) and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14)];4.Urinary vitamin E metabolite levels.[Measured at baseline (at the beginning of the study and also at the end of week 9, i.e. after the wash out period) and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14)]
- Secondary Outcome Measures
Name Time Method