Quinoa Biscuit & CVD Risk Trial
Primary Purpose
Cardiovascular Diseases, Dyslipidemias, Lipid Profile
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Quinoa biscuit
Control biscuit
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Quinoa, Functional food, Cardiovascular disease, Cholesterol, Lipid profile, Randomised Control Trial
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
Sites / Locations
- Human Intervention Studies Unit, Ulster University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Quinoa Biscuit
Control biscuit
Arm Description
The quinoa-enriched biscuits containing 7.11g quinoa flour.
The placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell.
Outcomes
Primary Outcome Measures
Total cholesterol
Plasma cholesterol
Secondary Outcome Measures
Triglycerides
measured in plasma
LDL-cholesterol
measured in plasma
HDL-cholesterol
measured in plasma
total/HDL-cholesterol ratio
measured in plasma
Poly-unsaturated fatty acid status
measured in plasma
Antioxidant status
Ferric-reducing Ability Plasma
Inflammatory status
C-reactive protein
Blood pressure
Diastolic and systolic
Weight
Kg
Full Information
NCT ID
NCT03291548
First Posted
September 19, 2017
Last Updated
September 19, 2017
Sponsor
University of Ulster
Collaborators
The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile
1. Study Identification
Unique Protocol Identification Number
NCT03291548
Brief Title
Quinoa Biscuit & CVD Risk Trial
Official Title
Effect of a Quinoa-enriched Biscuit as Novel Food Product to Improve CVD Risk Markers in Older Adults: a Randomised Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
June 19, 2017 (Actual)
Study Completion Date
June 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster
Collaborators
The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Dyslipidemias, Lipid Profile
Keywords
Quinoa, Functional food, Cardiovascular disease, Cholesterol, Lipid profile, Randomised Control Trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double Blind: researcher and particiapant unaware of the intervention assignment
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quinoa Biscuit
Arm Type
Experimental
Arm Description
The quinoa-enriched biscuits containing 7.11g quinoa flour.
Arm Title
Control biscuit
Arm Type
Placebo Comparator
Arm Description
The placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell.
Intervention Type
Dietary Supplement
Intervention Name(s)
Quinoa biscuit
Intervention Description
2x15g biscuits per day for 28 consecutive days (4 weeks).
Intervention Type
Dietary Supplement
Intervention Name(s)
Control biscuit
Intervention Description
2x15g biscuits per day for 28 consecutive days (4 weeks).
Primary Outcome Measure Information:
Title
Total cholesterol
Description
Plasma cholesterol
Time Frame
Change from baseline compared to control arm
Secondary Outcome Measure Information:
Title
Triglycerides
Description
measured in plasma
Time Frame
Change from baseline compared to control arm
Title
LDL-cholesterol
Description
measured in plasma
Time Frame
Change from baseline compared to control arm
Title
HDL-cholesterol
Description
measured in plasma
Time Frame
Change from baseline compared to control arm
Title
total/HDL-cholesterol ratio
Description
measured in plasma
Time Frame
Change from baseline compared to control arm
Title
Poly-unsaturated fatty acid status
Description
measured in plasma
Time Frame
Change from baseline compared to control arm
Title
Antioxidant status
Description
Ferric-reducing Ability Plasma
Time Frame
Change from baseline compared to control arm
Title
Inflammatory status
Description
C-reactive protein
Time Frame
Change from baseline compared to control arm
Title
Blood pressure
Description
Diastolic and systolic
Time Frame
Change from baseline compared to control arm
Title
Weight
Description
Kg
Time Frame
Change from baseline compared to control arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Human Intervention Studies Unit, Ulster University
City
Coleraine
State/Province
Londonderry
ZIP/Postal Code
BT52 1SA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31919583
Citation
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.
Results Reference
derived
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Quinoa Biscuit & CVD Risk Trial
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