FoodNCT04396275
The Effect of Navy Beans and Yellow Peas on Satiety in Children
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
The frequent consumption of pulses is associated with multiple cardiometabolic benefits in adults including a lower risk for overweight and obesity. However, it remains unclear whether these effects are mediated through the short-term mechanisms, including enhanced satiety and reduced food intake (FI), or through the… Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy 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
- 53 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2017to 31 Mar 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy boys and girls born at full-term
- do not receive any medications
Who cannot join
- Food sensitivities or allergies
- Dietary restrictions
- Health problems
- Learning, emotional or behavioral problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cooked Whole Navy Beans and Yellow Peas on Short-term Satiety and Food Intake in Children
The frequent consumption of pulses is associated with multiple cardiometabolic benefits in adults including a lower risk for overweight and obesity. However, it remains unclear whether these effects are mediated through the short-term mechanisms, including enhanced satiety and reduced food intake (FI), or through the long-term metabolic effects triggered by regular consumption of pulses. The objective of this study is to investigate the short-term effect of cooked pulses served in the amount similar to their recommended serving of 175ml (3/4 cup) on food intake in 12-14y children, and gastrointestinal comfort over 2-hours. The secondary objective is to evaluate how children perceive the sensory characteristics of the meals made with the whole pulses.
- Conditions
- Food, Eating, Satiety, Physical Comfort
- Being tested
- Food-1, Food-2, Food-3
- Keywords
- Pulses, Satiety, Food intake, Appetite, Beans, Peas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food-1Other
Cooked whole navy beans (300 kcal)
Food-2Other
Cooked whole yellow split peas (300 kcal)
Food-3Other
Cooked rice considered as control (300 kcal)
| Study group | Role | What they receive |
|---|---|---|
| Cooked whole navy beans | Experimental | A meal consisting of cooked navy beans Receives: Other: Food-1 |
| Cooked whole yellow split peas | Experimental | A meal consisting of cooked yellow peas Receives: Other: Food-2 |
| Cooked rice (control) | Experimental | A meal consisting of cooked rice 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 breakfast meal or water control and with the test meal (pizza lunch) two hours later.
Measured: 120 min
Subjective appetite
The subjective assessment of appetite parameters including 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 min
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 min
Secondary outcomes (1)
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 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Aug 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
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
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Saint Vincent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bohdan Luhovyy, PhD, Principal investigator, Mount Saint Vincent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396275
- Sponsor's protocol ID
- 2017-002
- Status last verified
- May 2020
- First submitted
- 1 Apr 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cooked Whole Navy Beans and Yellow Peas on Short-term Satiety and Food Intake in Children
- ClinicalTrials.gov ID
- NCT04396275
- Acronym / sponsor ID
- 2017-002
- Conditions
- Food, Eating, Satiety, Physical Comfort
- Keywords
- Pulses, Satiety, Food intake, Appetite, Beans, Peas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mount Saint Vincent UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 20 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.
The frequent consumption of pulses is associated with multiple cardiometabolic benefits in adults including a lower risk for overweight and obesity. However, it remains unclear whether these effects are mediated through the short-term mechanisms, including enhanced satiety and reduced food intake (FI), or through the long-term metabolic effects triggered by regular consumption of pulses. The objective of this study is to investigate the short-term effect of cooked pulses served in the amount similar to their recommended serving of 175ml (3/4 cup) on food intake in 12-14y children, and gastrointestinal comfort over 2-hours. The secondary objective is to evaluate how children perceive the sensory characteristics of the meals made with the whole pulses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cooked whole navy beans | Experimental | Other: Food-1A meal consisting of cooked navy beans |
| Cooked whole yellow split peas | Experimental | Other: Food-2A meal consisting of cooked yellow peas |
| Cooked rice (control) | Experimental | Other: Food-3A meal consisting of cooked rice |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy boys and girls born at full-term
- do not receive any medications
Key exclusion criteria (4 listed)
- Food sensitivities or allergies
- Dietary restrictions
- Health problems
- Learning, emotional or behavioral problems.
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 whole navy beans (300 kcal) | Other | Cooked whole navy beans |
| Food-2Cooked whole yellow split peas (300 kcal) | Other | Cooked whole yellow split peas |
| Food-3Cooked rice considered as control (300 kcal) | Other | Cooked rice (control) |
Primary outcome
Food intake
Time frame: 120 min
The amount of energy (kcal) consumed ad libitum with the breakfast meal or water control and with the test meal (pizza lunch) two hours later.
Subjective appetite
Time frame: 0-120 min
The subjective assessment of appetite parameters including 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).
Subjective feeling of physical comfort
Time frame: 0-120 min
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.
1 secondary outcome
Subjective perception of food palatability (pleasantness)
Time frame: 0, 120 min
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 20 May 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 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 4 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 20 May 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 min). The study lists 3 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 20 May 2020.