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Completed

NCT Number: NCT03291548

Quinoa Biscuit & CVD Risk Trial

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit, Ulster University

Coleraine, Londonderry, BT52 1SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quinoa biscuit

Dietary Supplement

2x15g biscuits per day for 28 consecutive days (4 weeks).

Control biscuit

Dietary Supplement

2x15g biscuits per day for 28 consecutive days (4 weeks).

Primary outcomes

  1. Total cholesterol

    Time frame: Change from baseline compared to control arm

    Plasma cholesterol

Secondary outcomes

  1. Triglycerides

    Time frame: Change from baseline compared to control arm

    measured in plasma

  2. LDL-cholesterol

    Time frame: Change from baseline compared to control arm

    measured in plasma

  3. HDL-cholesterol

    Time frame: Change from baseline compared to control arm

    measured in plasma

  4. total/HDL-cholesterol ratio

    Time frame: Change from baseline compared to control arm

    measured in plasma

  5. Poly-unsaturated fatty acid status

    Time frame: Change from baseline compared to control arm

    measured in plasma

  6. Antioxidant status

    Time frame: Change from baseline compared to control arm

    Ferric-reducing Ability Plasma

  7. Inflammatory status

    Time frame: Change from baseline compared to control arm

    C-reactive protein

  8. Blood pressure

    Time frame: Change from baseline compared to control arm

    Diastolic and systolic

  9. Weight

    Time frame: Change from baseline compared to control arm

    Kg

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile

Registry information

Official study title

Effect of a Quinoa-enriched Biscuit as Novel Food Product to Improve CVD Risk Markers in Older Adults: a Randomised Crossover Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2017
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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