FoodNCT04377282
The Effect of Buckwheat and Couscous on Satiety and Food Intake in Young Adults
A study testing Food-1, Food-2 and Food-3 in people with Food and Eating, run by Mount Saint Vincent University at 1 site in Canada.
Trial summary
A diet rich in whole grains has been linked to multiple beneficial health outcomes, including cardiovascular health, weight loss and a decreased risk of acquiring type 2 diabetes. However, grain products vary due to their botanical origin, composition, and post-harvest processing. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- What is being tested?
- Food-1, Food-2 and Food-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to 26 Jun 2020
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- 18-30 years
Who cannot join
- Smokers
- Taking medication
- Breakfast skippers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Buckwheat on Blood Glucose, Satiety and Food Intake
A diet rich in whole grains has been linked to multiple beneficial health outcomes, including cardiovascular health, weight loss and a decreased risk of acquiring type 2 diabetes. However, grain products vary due to their botanical origin, composition, and post-harvest processing. While wheat is considered a dominant grain crop in Canada, the minor crops, including gluten-free buckwheat, become popular alternatives to wheat products such as couscous. Both buckwheat groats and couscous are traditionally consumed in the form of the porridge or side dish, however, their acute effects on satiety and food intake remain unknown. The objective of this study is to investigate the short-term effects of couscous and buckwheat on satiety and short-term food intake in young adult males.
- Being tested
- Food-1, Food-2, Food-3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food-1Other
Cooked buckwheat
Food-2Other
Cooked couscous
Food-3Other
Water
| Study group | Role | What they receive |
|---|---|---|
| Buckwheat | Experimental | Cooked buckwheat Receives: Other: Food-1 |
| Couscous | Experimental | Cooked couscous Receives: Other: Food-2 |
| Water | Experimental | Potable water Receives: Other: Food-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
The amount of energy (kcal) consumed ad libitum with the test meal (pizza lunch) two hours later.
Measured: 120 minutes
Subjective appetite
The subjective assessment of appetite parameters including a desire to eat, fullness, hunger and a prospective food consumption measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., for the hunger scale, 0 mm means not hungry at all, and 100 mm means very hungry).
Measured: 0-120 minutes
Secondary outcomes (2)
Subjective feeling of physical comfort
The subjective assessment of wellness and gastrointestinal symptoms including a feeling of nausea, diarrhea, flatulence, and other parameters measured with 100 mm Visual Analogue Scales with two opposite statements at each end.
Measured: 0-120 minutes
Subjective perception of food palatability (pleasantness)
The pleasantness of the meals measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., 0 mm means that food is not pleasant at all, and 100 mm means that the food is very pleasant).
Measured: 0, 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study startMar 2012
- Primary completion15 Mar 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FoodStudies 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
- Model description
- Randomized crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Saint Vincent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bohdan Luhovyy, Mount Saint Vincent University
- Investigators
- Bohdan L. L Luhovyy, PhD, Principal investigator, Mount Saint Vincent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377282
- Sponsor's protocol ID
- 2019-085
- Status last verified
- Aug 2020
- First submitted
- 2 May 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Buckwheat on Blood Glucose, Satiety and Food Intake
- ClinicalTrials.gov ID
- NCT04377282
- Acronym / sponsor ID
- 2019-085
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mount Saint Vincent UniversityUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 6 May 2020 (actual)
- 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.
A diet rich in whole grains has been linked to multiple beneficial health outcomes, including cardiovascular health, weight loss and a decreased risk of acquiring type 2 diabetes. However, grain products vary due to their botanical origin, composition, and post-harvest processing. While wheat is considered a dominant grain crop in Canada, the minor crops, including gluten-free buckwheat, become popular alternatives to wheat products such as couscous. Both buckwheat groats and couscous are traditionally consumed in the form of the porridge or side dish, however, their acute effects on satiety and food intake remain unknown. The objective of this study is to investigate the short-term effects of couscous and buckwheat on satiety and short-term food intake in young adult males.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized crossover
| Arm | Type | Receives |
|---|---|---|
| Buckwheat | Experimental | Other: Food-1Cooked buckwheat |
| Couscous | Experimental | Other: Food-2Cooked couscous |
| Water | Experimental | Other: Food-3Potable water |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- 18-30 years
Key exclusion criteria (3 listed)
- Smokers
- Taking medication
- Breakfast skippers
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 |
|---|---|---|
| Food-1Cooked buckwheat | Other | Buckwheat |
| Food-2Cooked couscous | Other | Couscous |
| Food-3Water | Other | Water |
Primary outcome
Food intake
Time frame: 120 minutes
The amount of energy (kcal) consumed ad libitum with the test meal (pizza lunch) two hours later.
Subjective appetite
Time frame: 0-120 minutes
The subjective assessment of appetite parameters including a desire to eat, fullness, hunger and a prospective food consumption measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., for the hunger scale, 0 mm means not hungry at all, and 100 mm means very hungry).
2 secondary outcomes
Subjective feeling of physical comfort
Time frame: 0-120 minutes
Subjective perception of food palatability (pleasantness)
Time frame: 0, 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Bohdan L. L Luhovyy, PhD principal investigator
Mount Saint Vincent 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 Food-1, Food-2 and Food-3 in people with Food and Eating, run by Mount Saint Vincent University at 1 site in Canada.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 1 Sep 2020. 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 Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake (time frame: 120 minutes). The study lists 2 primary outcomes in all. 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 1 Sep 2020.