Change in Fasting Plasma LDL-cholesterol Concentration After the Consumption of QuinoaNCT03036618
Effects of Quinoa Consumption on Markers of Cardiovascular Risk and Gastrointestinal Health
A study testing Quinoa and Wheat in people with Change in Fasting Plasma LDL-cholesterol Concentration After the Consumption of Quinoa, run by Newcastle University at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 35 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Change in Fasting Plasma LDL-cholesterol Concentration After the Consumption of Quinoa
- What is being tested?
- Quinoa and Wheat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Liangkui Li contact
United Kingdom1 site, 1 recruiting
- Recruiting
NU-Food Research Facility
Newcastle upon Tyne, Tyne and Wear, NE1 7RU
Anthony Watson, PhD, anthony.watson@ncl.ac.uk
Liangkui Li
About this study
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.
Read the 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.
- Being tested
- Quinoa, Wheat
- Keywords
- BMI, Blood Cholesterol, Glucose, Insulin, Gut health
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuinoaDietary supplement
Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day.
WheatDietary supplement
Test wheat bread roll (approximately 160g weight) without quinoa.
| Study group | Role | What they receive |
|---|---|---|
| Wheat | Placebo comparator | Test wheat bread roll (approximately 160g weight) without quinoa. Receives: Dietary Supplement: Wheat |
| Quinoa | Experimental | Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day. Receives: Dietary Supplement: Quinoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma LDL-cholesterol
Measured: Change from post dose after 4 weeks of intervention
Secondary outcomes (7)
BMI
Measured: Change from post dose after 4 weeks of intervention
Body fat
Measured: Change from post dose after 4 weeks of intervention
Blood pressure
Measured: Change from post dose after 4 weeks of intervention
Fasting Blood glucose and insulin
Measured: Change from post dose after 4 weeks of intervention
Fasting blood lipid profile
Measured: Change from post dose after 4 weeks of intervention
Stool Microbiome profile
Measured: Change from post dose after 4 weeks of intervention
short chain fatty acid profile of stool samples
Measured: Change from post dose after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionFeb 2017 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Change in Fasting Plasma LDL-cholesterol Concentration After the Consumption of QuinoaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Seal, Professor, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036618
- Sponsor's protocol ID
- NUHEALTH-LL01-Quinoa
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Quinoa Consumption on Markers of Cardiovascular Risk and Gastrointestinal Health
- ClinicalTrials.gov ID
- NCT03036618
- Acronym / sponsor ID
- NUHEALTH-LL01-Quinoa
- Keywords
- BMI, Blood Cholesterol, Glucose, Insulin, Gut health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheat | Placebo comparator | Dietary Supplement: WheatTest wheat bread roll (approximately 160g weight) without quinoa. |
| Quinoa | Experimental | Dietary Supplement: QuinoaTest wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuinoaTest wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day. | Dietary supplement | Quinoa |
| WheatTest wheat bread roll (approximately 160g weight) without quinoa. | Dietary supplement | Wheat |
Primary outcome
plasma LDL-cholesterol
Time frame: Change from post dose after 4 weeks of intervention
7 secondary outcomes
BMI
Time frame: Change from post dose after 4 weeks of intervention
Body fat
Time frame: Change from post dose after 4 weeks of intervention
Blood pressure
Time frame: 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
Fasting blood lipid profile
Time frame: Change from post dose after 4 weeks of intervention
Stool Microbiome profile
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liangkui Li contact
Chris Seal, Professor principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quinoa and Wheat in people with Change in Fasting Plasma LDL-cholesterol Concentration After the Consumption of Quinoa, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liangkui Li (l.li11@ncl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma LDL-cholesterol (time frame: Change from post dose after 4 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.