Quinoa Biscuit & CVD Risk Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291548
• Other study ID #: UREC/16/0106
• Status: Completed
• Phase: N/A
• First received: September 19, 2017
• Last updated: September 19, 2017
• Start date: February 13, 2017
• Est. completion date: June 19, 2017

Study information

• Verified date: September 2017
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dyslipidemias
• Lipid Profile

Intervention

Dietary Supplement:
• Quinoa biscuit
2x15g biscuits per day for 28 consecutive days (4 weeks).
• Control biscuit
2x15g biscuits per day for 28 consecutive days (4 weeks).

Locations

Country	Name	City	State
United Kingdom	Human Intervention Studies Unit, Ulster University	Coleraine	Londonderry

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile

Country where clinical trial is conducted

United Kingdom, 

Outcome

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