Quinoa Biscuit & CVD Risk Trial | NCT03291548

Studies
Quinoa Biscuit & CVD Risk Trial

NCT03291548

Sponsor

University of Ulster

Status

Completed

Last Update Posted

Sep 25, 2017Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Cardiovascular Diseases
Dyslipidemias
Lipid Profile

Interventions

Quinoa biscuit
Control biscuit

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2017Actual

Primary Completion Date

Jun 19, 2017Actual

Completion Date

Jun 19, 2017Actual

First Submitted Date

Sep 19, 2017

First Submission Date that Met QC Criteria

Sep 19, 2017

First Posted Date

Sep 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2017

Last Update Posted Date

Sep 25, 2017Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Quinoa Biscuit	Experimental	The quinoa-enriched biscuits containing 7.11g quinoa flour.	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.	Dietary Supplement: Control biscuit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quinoa biscuit	Dietary Supplement	2x15g biscuits per day for 28 consecutive days (4 weeks).	Quinoa Biscuit

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Human Intervention Studies Unit, Ulster University		Coleraine	Londonderry	BT52 1SA	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31919583	Derived	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.

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D002318	Cardiovascular Diseases
D050171	Dyslipidemias