NCT03036618

Brief Summary

Quinoa is possible alternative to wheat, corn and rice due to its high nutritional value and possible properties against cardiovascular diseases and for improving gut health. There are some animal studies to suggest that some important class of compounds like fibre, antioxidants and protein, found naturally in quinoa, have beneficial effects against markers of cardiovascular diseases. However, the effects of quinoa on humans has rarely been investigated. This study will investigate the effects of daily consumption of quinoa for four weeks on markers of cardiovascular risk, including blood cholesterol and resting blood pressure, and on gut health in a randomised cross-over study design.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

January 26, 2017

Last Update Submit

January 26, 2017

Conditions

Change in Fasting Plasma LDL-cholesterol Concentration After the Consumption of Quinoa

Keywords

BMIBlood CholesterolGlucoseInsulinGut health

Outcome Measures

Primary Outcomes (1)

  • plasma LDL-cholesterol

    Change from post dose after 4 weeks of intervention

Secondary Outcomes (7)

  • BMI

    Change from post dose after 4 weeks of intervention

  • Body fat

    Change from post dose after 4 weeks of intervention

  • Blood pressure

    Change from post dose after 4 weeks of intervention

  • Fasting Blood glucose and insulin

    Change from post dose after 4 weeks of intervention

  • Fasting blood lipid profile

    Change from post dose after 4 weeks of intervention

  • +2 more secondary outcomes

Study Arms (2)

Wheat

PLACEBO COMPARATOR

Test wheat bread roll (approximately 160g weight) without quinoa.

Dietary Supplement: Wheat

Quinoa

EXPERIMENTAL

Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day.

Dietary Supplement: Quinoa

Interventions

QuinoaDIETARY_SUPPLEMENT

Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day.

Quinoa
WheatDIETARY_SUPPLEMENT

Test wheat bread roll (approximately 160g weight) without quinoa.

Wheat

Eligibility Criteria

Age35 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy men \>35 years old
  • body mass index \>25 kg/m2
  • Non-smokers with no known previous history of cardiovascular disease or type 2 diabetes
  • Not receiving any current medication. Supplement users will be included but will be asked to stop taking supplements for the duration of the study

You may not qualify if:

  • Age ≤ 35 or BMI ≤25
  • Smokers
  • Individuals with known or suspected allergy to wheat
  • Individuals with known history of cardiovascular diseases or type 2 diabetes
  • Individuals with recent weight loss (\>10%) or planning to lose weight during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NU-Food Research Facility

Newcastle upon Tyne, Tyne and Wear, NE1 7RU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Interventions

chenopodin protein, Chenopodium quinoaFlour

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Chris Seal, Professor

    Newcastle University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangkui Li

CONTACT

l.li11@ncl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

August 1, 2016

Primary Completion

February 1, 2017

Study Completion

September 1, 2018

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

GB(1)