Quinoa Biscuit & CVD Risk Trial
Effect of a Quinoa-enriched Biscuit as Novel Food Product to Improve CVD Risk Markers in Older Adults: a Randomised Crossover Study
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Feb 2017
Shorter than P25 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2017
CompletedFirst Submitted
Initial submission to the registry
September 19, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedSeptember 25, 2017
September 1, 2017
4 months
September 19, 2017
September 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total cholesterol
Plasma cholesterol
Change from baseline compared to control arm
Secondary Outcomes (9)
Triglycerides
Change from baseline compared to control arm
LDL-cholesterol
Change from baseline compared to control arm
HDL-cholesterol
Change from baseline compared to control arm
total/HDL-cholesterol ratio
Change from baseline compared to control arm
Poly-unsaturated fatty acid status
Change from baseline compared to control arm
- +4 more secondary outcomes
Study Arms (2)
Quinoa Biscuit
EXPERIMENTALThe quinoa-enriched biscuits containing 7.11g quinoa flour.
Control biscuit
PLACEBO COMPARATORThe placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell.
Interventions
2x15g biscuits per day for 28 consecutive days (4 weeks).
2x15g biscuits per day for 28 consecutive days (4 weeks).
Eligibility Criteria
You may qualify if:
- Free-living, apparently healthy adults
- Aged 50-75 years at recruitment
- Low fish consumers (\<2 servings/wk)
- Non-smokers
- Not regularly consuming plant stanols
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Human Intervention Studies Unit, Ulster University
Coleraine, Londonderry, BT52 1SA, United Kingdom
Related Publications (1)
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.
PMID: 31919583DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double Blind: researcher and particiapant unaware of the intervention assignment
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2017
First Posted
September 25, 2017
Study Start
February 13, 2017
Primary Completion
June 19, 2017
Study Completion
June 19, 2017
Last Updated
September 25, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share