Postprandial Glycemia in Healthy AdultsNCT02923089
Postprandial Blood Glucose and Insulin Levels Following Consumption of Lentil-containing Food Products
A study testing Muffin: 25g available carbohydrate from small green lentil, Muffin: 25g available carbohydrate from split red lentil and Wheat muffin in people with Postprandial Glycemia in Healthy Adults, run by University of Guelph at 1 site in Canada.
Trial summary
This study will recruit 20 healthy adults (male and female) to complete 9 study visits where they will consume different food products (chili, soup and muffin) with or without lentils incorporated into the them. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glycemia in Healthy Adults
- What is being tested?
- Muffin: 25g available carbohydrate from small green lentil, Muffin: 25g available carbohydrate from split red lentil and Wheat muffin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Age 18-40 years (aiming for equal distribution among 18-29, 30-40 years of age)
- BMI 20-30 kg/m2
Who cannot join
- Diabetes (fasting blood glucose ≥7.0 mmol/L and/or 2hr blood glucose >11.1 mmol/L post-75g OGTT) 1
- Impaired Glucose Tolerance (IGT) (Fasting blood glucose 6.1-6.9 mmol/L and/or 2hr blood glucose 7.8-11.0 mmol/L post-75g OGTT) 1
- Blood pressure >140/90 mm Hg
- Any major medical condition including a history of AIDS or hepatitis
- Medical or surgical event requiring hospitalization within 3 months of randomization
- Any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications
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- Natural health products (NHPs) used for glycemic control (all other NHPs okay as long as table for 3 months)
- Tobacco use
- Probiotic supplement use
- Dietary fibre supplement use
- Pulse consumption >4 servings per week
- Food allergy or non-food life threatening allergy
- Alcohol consumption >14 drinks/week or >4 drinks/sitting
- Recent or intended significant weight loss or gain (>4 kg in previous 3 months)
- Elite athletes
- Shift workers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Love of Lentils (LoL) Study - Phase 2: The Effect of Acute Consumption of Lentil-containing Food Products on Post-prandial Blood Glucose and Insulin in Healthy Adults
This study will recruit 20 healthy adults (male and female) to complete 9 study visits where they will consume different food products (chili, soup and muffin) with or without lentils incorporated into the them. Blood samples will be obtained by finger prick before and for 2 hours after the meal and analyzed for glucose and insulin.
Read the detailed description
The purpose of the current study is to determine the effects of lentil-containing food products on postprandial blood glucose and insulin levels in healthy premenopausal women and men aged 18-40 years old.This study will use a randomized crossover design. Participants will complete a series of 9 study visits during which participants will consume 9 study treatment meals consisting of muffins, soup and chilli, with and without lentils. Participants will then have their blood sampled for the following 2 hours by finger prick. Participants will remain seated during the test period. All study visits will occur at the Human Nutraceutical Research Unit and be separated by a washout period of 3-7 days. Throughout the study, it will be asked that participants' lifestyle and physical activity remain unchanged. Participants will be instructed to not start any new dietary approaches, and to not start any new natural health products (unless instructed by a physician).
- Conditions
- Postprandial Glycemia in Healthy Adults
- Being tested
- Muffin: 25g available carbohydrate from small green lentil, Muffin: 25g available carbohydrate from split red lentil, Wheat muffin, Soup: 25g available carbohydrate from small green lentil, Soup: 25g available carbohydrate from split red lentil
- Keywords
- Diabetes, Lentils, Pulses, Postprandial glycemia
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muffin: 25g available carbohydrate from small green lentilOther
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Muffin: 25g available carbohydrate from split red lentilOther
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Wheat muffinOther
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Soup: 25g available carbohydrate from small green lentilOther
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Soup: 25g available carbohydrate from split red lentilOther
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Potato soupOther
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Chili: 25g available carbohydrate from small green lentilOther
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Chili: 25g available carbohydrate from split red lentilOther
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Rice chiliOther
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
| Study group | Role | What they receive |
|---|---|---|
| Small Green Lentil Muffin | Experimental | Muffin: 25g available carbohydrate from small green lentil Receives: Other: Muffin: 25g available carbohydrate from small green lentil |
| Split Red Lentil Muffin | Experimental | Muffin: 25g available carbohydrate from split red lentil Receives: Other: Muffin: 25g available carbohydrate from split red lentil |
| Wheat Muffin | Placebo comparator | Muffin: 25g available carbohydrate from wheat Receives: Other: Wheat muffin |
| Small Green Lentil Soup | Experimental | Soup: 25g available carbohydrate from small green lentil Receives: Other: Soup: 25g available carbohydrate from small green lentil |
| Split Red Lentil Soup | Experimental | Soup: 25g available carbohydrate from split red lentil Receives: Other: Soup: 25g available carbohydrate from split red lentil |
| Potato Soup | Placebo comparator | Soup: 25g available carbohydrate from potato Receives: Other: Potato soup |
| Small Green Lentil Chili | Experimental | Chili: 25g available carbohydrate from small green lentil Receives: Other: Chili: 25g available carbohydrate from small green lentil |
| Split Red Lentil Chili | Experimental | Chili: 25g available carbohydrate from split red lentil Receives: Other: Chili: 25g available carbohydrate from split red lentil |
| Rice Chili | Placebo comparator | Chili: 25g available carbohydrate from rice Receives: Other: Rice chili |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose
Measured: 2 hours postprandial
Postprandial plasma insulin
Measured: 2 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Glycemia in Healthy AdultsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Responsible party
- Principal investigator, Alison Duncan, University of Guelph
- Investigators
- Alison M Duncan, PhD, RD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923089
- Sponsor's protocol ID
- 16AU008
- Status last verified
- Mar 2018
- First submitted
- 25 Sep 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Love of Lentils (LoL) Study - Phase 2: The Effect of Acute Consumption of Lentil-containing Food Products on Post-prandial Blood Glucose and Insulin in Healthy Adults
- ClinicalTrials.gov ID
- NCT02923089
- Acronym / sponsor ID
- 16AU008
- Conditions
- Postprandial Glycemia in Healthy Adults
- Keywords
- Diabetes, Lentils, Pulses, Postprandial glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 Oct 2016 (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.
This study will recruit 20 healthy adults (male and female) to complete 9 study visits where they will consume different food products (chili, soup and muffin) with or without lentils incorporated into the them. Blood samples will be obtained by finger prick before and for 2 hours after the meal and analyzed for glucose and insulin.
Detailed description
The purpose of the current study is to determine the effects of lentil-containing food products on postprandial blood glucose and insulin levels in healthy premenopausal women and men aged 18-40 years old.This study will use a randomized crossover design. Participants will complete a series of 9 study visits during which participants will consume 9 study treatment meals consisting of muffins, soup and chilli, with and without lentils. Participants will then have their blood sampled for the following 2 hours by finger prick. Participants will remain seated during the test period. All study visits will occur at the Human Nutraceutical Research Unit and be separated by a washout period of 3-7 days. Throughout the study, it will be asked that participants' lifestyle and physical activity remain unchanged. Participants will be instructed to not start any new dietary approaches, and to not start any new natural health products (unless instructed by a physician).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Small Green Lentil Muffin | Experimental | Other: Muffin: 25g available carbohydrate from small green lentilMuffin: 25g available carbohydrate from small green lentil |
| Split Red Lentil Muffin | Experimental | Other: Muffin: 25g available carbohydrate from split red lentilMuffin: 25g available carbohydrate from split red lentil |
| Wheat Muffin | Placebo comparator | Other: Wheat muffinMuffin: 25g available carbohydrate from wheat |
| Small Green Lentil Soup | Experimental | Other: Soup: 25g available carbohydrate from small green lentilSoup: 25g available carbohydrate from small green lentil |
| Split Red Lentil Soup | Experimental | Other: Soup: 25g available carbohydrate from split red lentilSoup: 25g available carbohydrate from split red lentil |
| Potato Soup | Placebo comparator | Other: Potato soupSoup: 25g available carbohydrate from potato |
| Small Green Lentil Chili | Experimental | Other: Chili: 25g available carbohydrate from small green lentilChili: 25g available carbohydrate from small green lentil |
| Split Red Lentil Chili | Experimental | Other: Chili: 25g available carbohydrate from split red lentilChili: 25g available carbohydrate from split red lentil |
| Rice Chili | Placebo comparator | Other: Rice chiliChili: 25g available carbohydrate from rice |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
- Age 18-40 years (aiming for equal distribution among 18-29, 30-40 years of age)
- BMI 20-30 kg/m2
Key exclusion criteria (16 listed)
- Diabetes (fasting blood glucose ≥7.0 mmol/L and/or 2hr blood glucose >11.1 mmol/L post-75g OGTT) 1
- Impaired Glucose Tolerance (IGT) (Fasting blood glucose 6.1-6.9 mmol/L and/or 2hr blood glucose 7.8-11.0 mmol/L post-75g OGTT) 1
- Blood pressure >140/90 mm Hg
- Any major medical condition including a history of AIDS or hepatitis
- Medical or surgical event requiring hospitalization within 3 months of randomization
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 |
|---|---|---|
| Muffin: 25g available carbohydrate from small green lentilComparison of postprandial blood glucose and insulin following consumption of food products with and without lentils. | Other | Small Green Lentil Muffin |
| Muffin: 25g available carbohydrate from split red lentilComparison of postprandial blood glucose and insulin following consumption of food products with and without lentils. | Other | Split Red Lentil Muffin |
| Wheat muffinComparison of postprandial blood glucose and insulin following consumption of food products with and without lentils. | Other | Wheat Muffin |
| Soup: 25g available carbohydrate from small green lentilComparison of postprandial blood glucose and insulin following consumption of food products with and without lentils. | Other | Small Green Lentil Soup |
| Soup: 25g available carbohydrate from split red lentilComparison of postprandial blood glucose and insulin following consumption of food products with and without lentils. | Other | Split Red Lentil Soup |
| Potato soupComparison of postprandial blood glucose and insulin following consumption of food products with and without lentils. | Other | Potato Soup |
| Chili: 25g available carbohydrate from small green lentilComparison of postprandial blood glucose and insulin following consumption of food products with and without lentils. | Other | Small Green Lentil Chili |
| Chili: 25g available carbohydrate from split red lentilComparison of postprandial blood glucose and insulin following consumption of food products with and without lentils. | Other | Split Red Lentil Chili |
| Rice chiliComparison of postprandial blood glucose and insulin following consumption of food products with and without lentils. | Other | Rice Chili |
Primary outcome
Postprandial blood glucose
Time frame: 2 hours postprandial
Postprandial plasma insulin
Time frame: 2 hours postprandial
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 3 Apr 2018.
- 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.
Alison M Duncan, PhD, RD principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muffin: 25g available carbohydrate from small green lentil, Muffin: 25g available carbohydrate from split red lentil and Wheat muffin in people with Postprandial Glycemia in Healthy Adults, run by University of Guelph 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 3 inclusion and 16 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 3 Apr 2018. 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. 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?
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?
Postprandial blood glucose (time frame: 2 hours postprandial). 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 3 Apr 2018.