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

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ClinicalTrials.gov Identifier: NCT03036618
Recruitment Status : Unknown
Verified January 2017 by Newcastle University.
Recruitment status was:  Recruiting
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Newcastle University

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.

Condition or disease Intervention/treatment Phase
Change in Fasting Plasma LDL-cholesterol Concentration After the Consumption of Quinoa Dietary Supplement: Quinoa Dietary Supplement: Wheat Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Quinoa Consumption on Markers of Cardiovascular Risk and Gastrointestinal Health
Study Start Date : August 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. plasma LDL-cholesterol [ Time Frame: Change from post dose after 4 weeks of intervention ]

Secondary Outcome Measures :
  1. BMI [ Time Frame: Change from post dose after 4 weeks of intervention ]
  2. Body fat [ Time Frame: Change from post dose after 4 weeks of intervention ]
  3. Blood pressure [ Time Frame: Change from post dose after 4 weeks of intervention ]
  4. Fasting Blood glucose and insulin [ Time Frame: Change from post dose after 4 weeks of intervention ]
  5. Fasting blood lipid profile [ Time Frame: Change from post dose after 4 weeks of intervention ]
  6. Stool Microbiome profile [ Time Frame: Change from post dose after 4 weeks of intervention ]
  7. short chain fatty acid profile of stool samples [ Time Frame: Change from post dose after 4 weeks of intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036618


Contacts
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Contact: Liangkui Li l.li11@ncl.ac.uk

Locations
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United Kingdom
NU-Food Research Facility Recruiting
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 7RU
Contact: Anthony Watson, PhD       anthony.watson@ncl.ac.uk   
Sub-Investigator: Liangkui Li         
Principal Investigator: Chris Seal, PhD         
Sponsors and Collaborators
Newcastle University
Investigators
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Principal Investigator: Chris Seal, Professor Newcastle University

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Responsible Party: Newcastle University
ClinicalTrials.gov Identifier: NCT03036618     History of Changes
Other Study ID Numbers: NUHEALTH-LL01-Quinoa
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Newcastle University:
BMI
Blood Cholesterol
Glucose
Insulin
Gut health