Quinoa Biscuit & CVD Risk Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases, Dyslipidemias, Lipid Profile

Intervention / Treatment
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* Dietary Supplement: Quinoa biscuit
* Dietary Supplement: Control biscuit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quinoa Biscuit<br>The quinoa-enriched biscuits containing 7.11g quinoa flour. | Dietary Supplement: Quinoa biscuit<br>* 2x15g biscuits per day for 28 consecutive days (4 weeks).<br>|
| Placebo Comparator: Control biscuit<br>The placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell. | Dietary Supplement: Control biscuit<br>* 2x15g biscuits per day for 28 consecutive days (4 weeks).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol | Plasma cholesterol | Change from baseline compared to control arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides | measured in plasma | Change from baseline compared to control arm | 
| LDL-cholesterol | measured in plasma | Change from baseline compared to control arm | 
| HDL-cholesterol | measured in plasma | Change from baseline compared to control arm | 
| total/HDL-cholesterol ratio | measured in plasma | Change from baseline compared to control arm | 
| Poly-unsaturated fatty acid status | measured in plasma | Change from baseline compared to control arm | 
| Antioxidant status | Ferric-reducing Ability Plasma | Change from baseline compared to control arm | 
| Inflammatory status | C-reactive protein | Change from baseline compared to control arm | 
| Blood pressure | Diastolic and systolic | Change from baseline compared to control arm | 
| Weight | Kg | Change from baseline compared to control arm | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular disease, Lipid profile, Randomised Control Trial, Quinoa, Functional food, Cholesterol