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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03036618
• Other study ID #: NUHEALTH-LL01-Quinoa
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2017
• Last updated: January 26, 2017
• Start date: August 2016
• Est. completion date: September 2018

Study information

• Verified date: January 2017
• Source: Newcastle University
• Contact: Liangkui Li
• Email: l.li11[@]ncl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Quinoa
Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day.
• Wheat
Test wheat bread roll (approximately 160g weight) without quinoa.

Locations

Country	Name	City	State
United Kingdom	NU-Food Research Facility	Newcastle upon Tyne	Tyne and Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma LDL-cholesterol		Change from post dose after 4 weeks of intervention
Secondary	BMI		Change from post dose after 4 weeks of intervention
Secondary	Body fat		Change from post dose after 4 weeks of intervention
Secondary	Blood pressure		Change from post dose after 4 weeks of intervention
Secondary	Fasting Blood glucose and insulin		Change from post dose after 4 weeks of intervention
Secondary	Fasting blood lipid profile		Change from post dose after 4 weeks of intervention
Secondary	Stool Microbiome profile		Change from post dose after 4 weeks of intervention
Secondary	short chain fatty acid profile of stool samples		Change from post dose after 4 weeks of intervention