Cardiovascular DiseasesNCT03291548
Quinoa Biscuit & CVD Risk Trial
A study testing Quinoa biscuit in people with Cardiovascular Diseases and Dyslipidemias, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Dyslipidemias, Lipid Profile
- What is being tested?
- Quinoa biscuit
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2017to 19 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Free-living, apparently healthy adults
- Aged 50-75 years at recruitment
- Low fish consumers (<2 servings/wk)
- Non-smokers
- Not regularly consuming plant stanols
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, Londonderry, BT52 1SA
About this study
Official title: Effect of a Quinoa-enriched Biscuit as Novel Food Product to Improve CVD Risk Markers in Older Adults: a Randomised Crossover Study
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.
- Conditions
- Cardiovascular Diseases, Dyslipidemias, Lipid Profile
- Being tested
- Quinoa biscuit, Control biscuit
- Keywords
- Quinoa, Functional food, Cardiovascular disease, Cholesterol, Lipid profile, Randomised Control Trial
- Medical subject headings
- Cardiovascular Diseases, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinoa biscuitDietary supplement
2x15g biscuits per day for 28 consecutive days (4 weeks).
Control biscuitDietary supplement
2x15g biscuits per day for 28 consecutive days (4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Quinoa Biscuit | Experimental | The quinoa-enriched biscuits containing 7.11g quinoa flour. Receives: Dietary Supplement: Quinoa biscuit |
| Control biscuit | Placebo comparator | The placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell. Receives: Dietary Supplement: Control biscuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
Plasma cholesterol
Measured: Change from baseline compared to control arm
Secondary outcomes (9)
Triglycerides
measured in plasma
Measured: Change from baseline compared to control arm
LDL-cholesterol
measured in plasma
Measured: Change from baseline compared to control arm
HDL-cholesterol
measured in plasma
Measured: Change from baseline compared to control arm
total/HDL-cholesterol ratio
measured in plasma
Measured: Change from baseline compared to control arm
Poly-unsaturated fatty acid status
measured in plasma
Measured: Change from baseline compared to control arm
Antioxidant status
Ferric-reducing Ability Plasma
Measured: Change from baseline compared to control arm
Inflammatory status
C-reactive protein
Measured: Change from baseline compared to control arm
Blood pressure
Diastolic and systolic
Measured: Change from baseline compared to control arm
Weight
Kg
Measured: Change from baseline compared to control arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start13 Feb 2017
- Primary completion19 Jun 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291548
- Sponsor's protocol ID
- UREC/16/0106
- Status last verified
- Sep 2017
- First submitted
- 19 Sep 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31919583
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Quinoa-enriched Biscuit as Novel Food Product to Improve CVD Risk Markers in Older Adults: a Randomised Crossover Study
- ClinicalTrials.gov ID
- NCT03291548
- Acronym / sponsor ID
- UREC/16/0106
- Conditions
- Cardiovascular Diseases, Dyslipidemias, Lipid Profile
- Keywords
- Quinoa, Functional food, Cardiovascular disease, Cholesterol, Lipid profile, Randomised Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quinoa Biscuit | Experimental | Dietary Supplement: Quinoa biscuitThe quinoa-enriched biscuits containing 7.11g quinoa flour. |
| Control biscuit | Placebo comparator | Dietary Supplement: Control biscuitThe placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Free-living, apparently healthy adults
- Aged 50-75 years at recruitment
- Low fish consumers (<2 servings/wk)
- Non-smokers
- Not regularly consuming plant stanols
Key exclusion criteria (10 listed)
- Non-free-living adults
- Aged <50 or >75 years at recruitment
- Fish consumers (2 servings/wk or more)
- Current smokers
- Pregnant/lactating females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quinoa biscuit2x15g biscuits per day for 28 consecutive days (4 weeks). | Dietary supplement | Quinoa Biscuit |
| Control biscuit2x15g biscuits per day for 28 consecutive days (4 weeks). | Dietary supplement | Control biscuit |
Primary outcome
Total cholesterol
Time frame: Change from baseline compared to control arm
Plasma cholesterol
9 secondary outcomes
Triglycerides
Time frame: Change from baseline compared to control arm
LDL-cholesterol
Time frame: Change from baseline compared to control arm
HDL-cholesterol
Time frame: Change from baseline compared to control arm
total/HDL-cholesterol ratio
Time frame: Change from baseline compared to control arm
Poly-unsaturated fatty acid status
Time frame: Change from baseline compared to control arm
Antioxidant status
Time frame: Change from baseline compared to control arm
Inflammatory status
Time frame: Change from baseline compared to control arm
Blood pressure
Time frame: Change from baseline compared to control arm
Weight
Time frame: Change from baseline compared to control arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Derived from this study: PubMed 31919583Pourshahidi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quinoa biscuit in people with Cardiovascular Diseases and Dyslipidemias, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cholesterol (time frame: Change from baseline compared to control arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03291548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.