Effects of Quinoa Consumption on Markers of Cardiovascular Risk and Gastrointestinal Health

January 26, 2017 updated by: Newcastle University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Quinoa is a possible alternative to wheat, corn and rice due to its high nutritional value and possible properties against cardiovascular diseases. There are some animal studies which suggest that quinoa has beneficial effects against markers of cardiovascular diseases, particularly blood lipid profile. The grain has a unique nutritional profile, with high fibre levels and a wide range of phytochemicals which may influence gut bacteria and improve gastrointestinal health.

However, the effects of quinoa on humans has rarely been investigated with just two small interventions published. These studies also showed an improvement in blood lipid profile after consuming quinoa daily. There have been no studies which have investigated the effects of quinoa on gut bacteria and gastrointestinal health. Therefore, this human dietary intervention study aims to determine the effects of quinoa consumption on markers of cardiovascular diseases, the gut microbiome and gastrointestinal health.

The study is a randomized cross-over designed dietary intervention study with 4-week study periods separated by a 4-week wash-out period. The treatment will be the daily consumption of a test bread roll containing quinoa to deliver 20g quinoa per day (one roll per day). The control will be the same amount of a refined wheat roll. Markers of cardiovascular disease risk, including fasting blood lipid profile, plasma glucose and insulin concentration, resting blood pressure will be compared at the beginning and end of each treatment period. Changes in the numbers and species of gut bacteria, and products of bacterial fermentation will be made in stool samples collected at the beginning and end of each intervention period as indicators of gastrointestinal health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 7RU
        • Recruiting
        • NU-Food Research Facility
        • Contact:
        • Sub-Investigator:
          • Liangkui Li
        • Principal Investigator:
          • Chris Seal, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Wheat
Test wheat bread roll (approximately 160g weight) without quinoa.
Dietary supplement: Wheat
Test wheat bread roll (approximately 160g weight) without quinoa.
Experimental: Quinoa
Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day.
Dietary supplement: Quinoa
Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
plasma LDL-cholesterol
Time Frame: Change from post dose after 4 weeks of intervention
Change from post dose after 4 weeks of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
BMI
Time Frame: Change from post dose after 4 weeks of intervention
Change from post dose after 4 weeks of intervention
Body fat
Time Frame: Change from post dose after 4 weeks of intervention
Change from post dose after 4 weeks of intervention
Blood pressure
Time Frame: Change from post dose after 4 weeks of intervention
Change from post dose after 4 weeks of intervention
Fasting Blood glucose and insulin
Time Frame: Change from post dose after 4 weeks of intervention
Change from post dose after 4 weeks of intervention
Fasting blood lipid profile
Time Frame: Change from post dose after 4 weeks of intervention
Change from post dose after 4 weeks of intervention
Stool Microbiome profile
Time Frame: Change from post dose after 4 weeks of intervention
Change from post dose after 4 weeks of intervention
short chain fatty acid profile of stool samples
Time Frame: Change from post dose after 4 weeks of intervention
Change from post dose after 4 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Newcastle University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chris Seal, Professor, Newcastle University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NUHEALTH-LL01-Quinoa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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