Normal WeightNCT03223935
Roasted Pulse Snacks, Post-prandial Food Intake, Appetite, and Glycemia
A study testing Corn nuts, Chickpeas and Yellow peas in people with Normal Weight and Overweight, run by University of Manitoba at 1 site in Canada.
Trial summary
An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety response in healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Weight, Overweight, Normoglycemic
- What is being tested?
- Corn nuts, Chickpeas and Yellow peas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 11 Aug 2017to 4 Apr 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: ≥18.5 and ≤29.9 kg/m2
- Fasting serum glucose: ≤5.5 mmol/L
Who cannot join
- Fasting serum glucose > 5.5 mmol/L
- Smoking
- Thyroid problems
- Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
- Presence of a gastrointestinal disorder or surgeries within the past year
- Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgment
Show all 13Show fewer
- Known to be pregnant or lactating
- Known intolerance, sensitivity or allergy to any ingredients in the study products.
- Extreme dietary habits (i.e. Atkins diet, very high protein diets, etc.)
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)
- Weight gain or loss of at least 10lbs in previous three months
- Excessive alcohol intake
- Restrained Eaters (identified by Eating Habits Questionnaire)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, R3T 6C5
About this study
Official title: A Comparison of Roasted Pulse Snacks on Post-prandial Food Intake, Appetite, and Glycemic Response in Healthy Young Adults
An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety response in healthy young adults.
Read the detailed description
An acute, randomized, controlled cross-over trial examining the post-prandial glycemic and satiety response to six snacks will be conducted. The study treatments are: 1) roasted corn nuts, 2) roasted chickpeas, 3) roasted yellow peas, 4) roasted pinto beans 5) roasted soybeans, and 6) roasted almonds. They will be matched for calorie content and provided in 200 kcal servings.
- Conditions
- Normal Weight, Overweight, Normoglycemic
- Being tested
- Corn nuts, Chickpeas, Yellow peas, Pinto beans, Soybeans
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corn nutsOther
Roasted corn nut snack
ChickpeasOther
Roasted chickpea snack
Yellow peasOther
Roasted yellow pea snack
Pinto beansOther
Roasted pinto bean snack
SoybeansOther
Roasted soybean snack
AlmondsOther
Roasted almond snack
| Study group | Role | What they receive |
|---|---|---|
| Roasted snacks | Active comparator | Corn nuts Receives: Other: Corn nuts |
| Roasted chickpeas | Experimental | Chickpeas Receives: Other: Chickpeas |
| Roasted yellow peas | Experimental | Yellow peas Receives: Other: Yellow peas |
| Roasted pinto beans | Experimental | Pinto beans Receives: Other: Pinto beans |
| Roasted soybeans | Experimental | Soybeans Receives: Other: Soybeans |
| Roasted almonds | Experimental | Almonds Receives: Other: Almonds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Ab libitum meal
Measured: At 60 min
Secondary outcomes (6)
Subjective appetite
Measured by VAS questionnaire at 12 time points used to calculate area under the curve
Measured: 0-200 min
Blood glucose concentrations
Measured in blood using a glucometer at 12 time points and used to calculate area under the curve
Measured: 0-200 min
Physical comfort
Measured by VAS questionnaire at 12 time points to calculate area under the curve
Measured: 0-200 min
Energy and fatigue
Measured by VAS questionnaire at 12 time points to calculate area under the curve
Measured: 0-200 min
Palatability of meal
Measured by VAS questionnaire
Measured: At 60 min
Palatability of treatment
Measured by VAS questionnaire
Measured: At 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start11 Aug 2017
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal WeightStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled cross-over acute trial
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Pulse Growers, Pulse Canada
- Responsible party
- Sponsor
- Investigators
- Peter JH Jones, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223935
- Sponsor's protocol ID
- HS20792 (B2017:059)
- Status last verified
- Apr 2021
- First submitted
- 6 Jul 2017
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data requests should be submitted to the PI.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Roasted Pulse Snacks on Post-prandial Food Intake, Appetite, and Glycemic Response in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT03223935
- Acronym / sponsor ID
- HS20792 (B2017:059)
- Conditions
- Normal Weight, Overweight, Normoglycemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Saskatchewan Pulse Growers, Pulse Canada
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 21 Jul 2017 (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.
An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety response in healthy young adults.
Detailed description
An acute, randomized, controlled cross-over trial examining the post-prandial glycemic and satiety response to six snacks will be conducted. The study treatments are: 1) roasted corn nuts, 2) roasted chickpeas, 3) roasted yellow peas, 4) roasted pinto beans 5) roasted soybeans, and 6) roasted almonds. They will be matched for calorie content and provided in 200 kcal servings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Randomized, controlled cross-over acute trial
| Arm | Type | Receives |
|---|---|---|
| Roasted snacks | Active comparator | Other: Corn nutsCorn nuts |
| Roasted chickpeas | Experimental | Other: ChickpeasChickpeas |
| Roasted yellow peas | Experimental | Other: Yellow peasYellow peas |
| Roasted pinto beans | Experimental | Other: Pinto beansPinto beans |
| Roasted soybeans | Experimental | Other: SoybeansSoybeans |
| Roasted almonds | Experimental | Other: AlmondsAlmonds |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI: ≥18.5 and ≤29.9 kg/m2
- Fasting serum glucose: ≤5.5 mmol/L
Key exclusion criteria (13 listed)
- Fasting serum glucose > 5.5 mmol/L
- Smoking
- Thyroid problems
- Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
- Presence of a gastrointestinal disorder or surgeries within the past year
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 |
|---|---|---|
| Corn nutsRoasted corn nut snack | Other | Roasted snacks |
| ChickpeasRoasted chickpea snack | Other | Roasted chickpeas |
| Yellow peasRoasted yellow pea snack | Other | Roasted yellow peas |
| Pinto beansRoasted pinto bean snack | Other | Roasted pinto beans |
| SoybeansRoasted soybean snack | Other | Roasted soybeans |
| AlmondsRoasted almond snack | Other | Roasted almonds |
Primary outcome
Food intake
Time frame: At 60 min
Ab libitum meal
6 secondary outcomes
Subjective appetite
Time frame: 0-200 min
Blood glucose concentrations
Time frame: 0-200 min
Physical comfort
Time frame: 0-200 min
Energy and fatigue
Time frame: 0-200 min
Palatability of meal
Time frame: At 60 min
Palatability of treatment
Time frame: At 5 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 23 Jan 2023.
- Individual participant dataSharing planned: No. Individual participant data requests should be submitted to the PI.
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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.
Peter JH Jones, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corn nuts, Chickpeas and Yellow peas in people with Normal Weight and Overweight, run by University of Manitoba 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 13 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 23 Jan 2023. 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: At 60 min). 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 23 Jan 2023.