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Quinoa Biscuit & CVD Risk Trial

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ClinicalTrials.gov Identifier: NCT03291548
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile
Information provided by (Responsible Party):
University of Ulster

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dyslipidemias Lipid Profile Dietary Supplement: Quinoa biscuit Dietary Supplement: Control biscuit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind: researcher and particiapant unaware of the intervention assignment
Primary Purpose: Prevention
Official Title: Effect of a Quinoa-enriched Biscuit as Novel Food Product to Improve CVD Risk Markers in Older Adults: a Randomised Crossover Study
Actual Study Start Date : February 13, 2017
Actual Primary Completion Date : June 19, 2017
Actual Study Completion Date : June 19, 2017

Arm Intervention/treatment
Experimental: Quinoa Biscuit
The quinoa-enriched biscuits containing 7.11g quinoa flour.
Dietary Supplement: Quinoa biscuit
2x15g biscuits per day for 28 consecutive days (4 weeks).

Placebo Comparator: Control biscuit
The placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell.
Dietary Supplement: Control biscuit
2x15g biscuits per day for 28 consecutive days (4 weeks).




Primary Outcome Measures :
  1. Total cholesterol [ Time Frame: Change from baseline compared to control arm ]
    Plasma cholesterol


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291548


Locations
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United Kingdom
Human Intervention Studies Unit, Ulster University
Coleraine, Londonderry, United Kingdom, BT52 1SA
Sponsors and Collaborators
University of Ulster
The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile

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Responsible Party: University of Ulster
ClinicalTrials.gov Identifier: NCT03291548     History of Changes
Other Study ID Numbers: UREC/16/0106
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Ulster:
Quinoa
Functional food
Cardiovascular disease
Cholesterol
Lipid profile
Randomised Control Trial

Additional relevant MeSH terms:
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Dyslipidemias
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases