Quinoa Biscuit & CVD Risk Trial

NCT ID: NCT03291548

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2017-06-19

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.

Detailed Description

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Conditions

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Cardiovascular Diseases Dyslipidemias Lipid Profile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Double Blind: researcher and particiapant unaware of the intervention assignment

Study Groups

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Quinoa Biscuit

The quinoa-enriched biscuits containing 7.11g quinoa flour.

Group Type EXPERIMENTAL

Quinoa biscuit

Intervention Type DIETARY_SUPPLEMENT

2x15g biscuits per day for 28 consecutive days (4 weeks).

Control biscuit

The placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell.

Group Type PLACEBO_COMPARATOR

Control biscuit

Intervention Type DIETARY_SUPPLEMENT

2x15g biscuits per day for 28 consecutive days (4 weeks).

Interventions

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Quinoa biscuit

2x15g biscuits per day for 28 consecutive days (4 weeks).

Intervention Type DIETARY_SUPPLEMENT

Control biscuit

2x15g biscuits per day for 28 consecutive days (4 weeks).

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile

UNKNOWN

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Human Intervention Studies Unit, Ulster University

Coleraine, Londonderry, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31919583 (View on PubMed)

Other Identifiers

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UREC/16/0106

Identifier Type: -

Identifier Source: org_study_id