Cardiovascular Diseases Clinical Trial
Official title:
Effect of a Quinoa-enriched Biscuit as Novel Food Product to Improve CVD Risk Markers in Older Adults: a Randomised Crossover Study
Verified date | September 2017 |
Source | University of Ulster |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cardiovascular disease (CVD) is one of the most common chronic diseases in older populations,
which has been increasing in line with rising overweight and obesity levels in recent years.
Dietary intake is a major modifiable risk factor for CVD, and one such recommendation is to
increase the intake of essential (omega-3) polyunsaturated fats in our diets, for example by
consuming more oily fish. We know, however, from large population level dietary surveys, that
many individuals within the United Kingdom (UK) population are not consuming enough oily
fish. Therefore, alternative dietary sources of omega-3 polyunsaturated fats are required to
help meet consumer needs.
Quinoa is a traditional Andean seed crop consumed in a similar fashion to staple cereal
grains in Europe, and the popularity of quinoa has been growing worldwide because of its
nutritional content and perceived healthiness. Quinoa contains a small amount of fat, but the
ratio of omega-6 and omega-3 essential fats is more favourable in quinoa than in other plant
oils. An opportunity therefore exists to incorporate quinoa flour into more frequently
consumed food products (e.g. biscuits) as an alternative means of increasing consumers
omega-3 intake.
The purpose of this study is to investigate the effect of consuming quinoa-enriched biscuits,
compared to control, on markers of CVD risk over 4-weeks in older adults.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 19, 2017 |
Est. primary completion date | June 19, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Free-living, apparently healthy adults - Aged 50-75 years at recruitment - Low fish consumers (<2 servings/wk) - Non-smokers - Not regularly consuming plant stanols Exclusion Criteria: - Non-free-living adults - Aged <50 or >75 years at recruitment - Fish consumers (2 servings/wk or more) - Current smokers - Pregnant/lactating females - Coeliac disease, wheat intolerance or any other food allergy or intolerance that would prevent consumption of the biscuits - Currently taking any fish oil-containing supplement - Diagnosed with a chronic medical condition (such as diabetes; CVD autoimmune/ inflammatory disorders; cancer) - Prescribed cholesterol or blood pressure lowering medications - Daily consumption of plant stanols |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Human Intervention Studies Unit, Ulster University | Coleraine | Londonderry |
Lead Sponsor | Collaborator |
---|---|
University of Ulster | The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total cholesterol | Plasma cholesterol | Change from baseline compared to control arm | |
Secondary | Triglycerides | measured in plasma | Change from baseline compared to control arm | |
Secondary | LDL-cholesterol | measured in plasma | Change from baseline compared to control arm | |
Secondary | HDL-cholesterol | measured in plasma | Change from baseline compared to control arm | |
Secondary | total/HDL-cholesterol ratio | measured in plasma | Change from baseline compared to control arm | |
Secondary | Poly-unsaturated fatty acid status | measured in plasma | Change from baseline compared to control arm | |
Secondary | Antioxidant status | Ferric-reducing Ability Plasma | Change from baseline compared to control arm | |
Secondary | Inflammatory status | C-reactive protein | Change from baseline compared to control arm | |
Secondary | Blood pressure | Diastolic and systolic | Change from baseline compared to control arm | |
Secondary | Weight | Kg | Change from baseline compared to control arm |
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