Clinical trial NCT03291548: Quinoa Biscuit & CVD Risk 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Dyslipidemias
Lipid Profile
Keywords: Quinoa
Functional food
Cardiovascular disease
Cholesterol
Lipid profile
Randomised Control Trial
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile
First posted: 2017-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Total cholesterol
timeFrame: Change from baseline compared to control arm
Secondary outcomes:
measure: Triglycerides
timeFrame: Change from baseline compared to control arm
measure: LDL-cholesterol
timeFrame: Change from baseline compared to control arm
measure: HDL-cholesterol
timeFrame: Change from baseline compared to control arm
measure: total/HDL-cholesterol ratio
timeFrame: Change from baseline compared to control arm
measure: Poly-unsaturated fatty acid status
timeFrame: Change from baseline compared to control arm
measure: Antioxidant status
timeFrame: Change from baseline compared to control arm
measure: Inflammatory status
timeFrame: Change from baseline compared to control arm
measure: Blood pressure
timeFrame: Change from baseline compared to control arm
measure: Weight
timeFrame: Change from baseline compared to control arm
Other outcomes:
Locations:
city: Coleraine
country: United Kingdom
facility: Human Intervention Studies Unit, Ulster University
state: Londonderry
Study officials:
References:
citation: Pourshahidi LK, Caballero E, Osses A, Hyland BW, Ternan NG, Gill CIR. Modest improvement in CVD risk markers in older adults following quinoa (Chenopodium quinoa Willd.) consumption: a randomized-controlled crossover study with a novel food product. Eur J Nutr. 2020 Oct;59(7):3313-3323. doi: 10.1007/s00394-019-02169-0. Epub 2020 Jan 9.