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

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 Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Dyslipidemias; Lipid Profile
• Intervention / Treatment: Dietary supplement: Quinoa biscuit; Dietary supplement: Control biscuit

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Londonderry
    • Coleraine, Londonderry, United Kingdom, BT52 1SA
      • Human Intervention Studies Unit, Ulster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Quinoa Biscuit; The quinoa-enriched biscuits containing 7.11g quinoa flour.	Dietary supplement: Quinoa biscuit; 2x15g biscuits per day for 28 consecutive days (4 weeks).
PLACEBO_COMPARATOR: Control biscuit; The placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell.	Dietary supplement: Control biscuit; 2x15g biscuits per day for 28 consecutive days (4 weeks).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 13, 2017
• Primary Completion (ACTUAL): June 19, 2017
• Study Completion (ACTUAL): June 19, 2017

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (ACTUAL): September 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Cholesterol; Lipid profile; Functional food; Randomised Control Trial; Quinoa
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Cardiovascular Diseases; Dyslipidemias
• Other Study ID Numbers: UREC/16/0106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No