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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Newcastle University

Investigators

  • 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

August 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID 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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