Insulin SensitivityNCT03941704
Pulse-based Foods for Alleviation of Negative Consequences of Sedentary Behaviour
A study testing Pulse-based diet and Regular diet in people with Insulin Sensitivity, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The hypothesis is that consumption of pulse-based foods (i.e. containing chickpeas, lentils, and split peas) during the workday will improve insulin sensitivity, glucose tolerance, blood lipids, body composition, and blood pressure in sedentary office workers.One-hundred office workers from a university campus will… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- Pulse-based diet and Regular diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2019to 30 Jun 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and Women
- 18y or older
- Engaged in >5 hours per day sitting
Who cannot join
- Diagnosed with diabetes
- taking glucose or lipid-lowering medication
- Regular consumers of pulses (1.5 cups (250g) or greater of pulses per week)
- Engaged in 60 minutes or greater of physical activity per day
Trial locations and contacts
1 site in 1 country.
Canada1 site
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan, S7N5B2
About this study
Official title: Development of Pre-Packaged Pulse-Based Meals to Ameliorate the Negative Health Consequences of Sedentary Behavior
The hypothesis is that consumption of pulse-based foods (i.e. containing chickpeas, lentils, and split peas) during the workday will improve insulin sensitivity, glucose tolerance, blood lipids, body composition, and blood pressure in sedentary office workers.One-hundred office workers from a university campus will participate in a cross-over study where they will be randomized (i.e. assigned by chance) to receive pre-packaged pulse-based lunches and snacks to replace their usual lunches/snacks during the work day OR to continue consuming their usual diets for two months. After the first dietary intervention, they will undergo a 1-month "wash-out" and then participate in two months of the opposite dietary intervention. The main outcome to be assessed is change in glucose and insulin (i.e. blood sugar control) determined during an oral glucose tolerance test. Secondary outcomes include changes in body composition, lipids, and blood pressure.
During the pulse-based diet phases, participants will be supplied with a ready-to-eat lunch and two snacks to eat during each workday. These will contain a total of 150g/d dry weight (250g/d wet weight) pulses
Read the detailed description
Sedentary behaviour has been deemed the "new smoking" based on multiple and potent negative impacts on health. Moreover, sedentary behaviour is a strong predictor of type 2 diabetes risk and cardiovascular disease. Previous studies have show that pulse-based meals derived from lentils, beans, chickpeas, and peas are effective for alleviating risk factors associated with diabetes and cardiovascular disease in clinical populations including older adults, overweight and obese individuals, and women with polycystic ovary syndrome; however, to date, there have been no nutrition-based interventions for alleviating risk factors for diabetes specifically targeting office workers exposed to long periods of sitting. Although people are aware of the health benefits of pulses, a major barrier to increased consumption continues to be a lack of knowledge on how to prepare pulse-based meals. This proposed study is designed to overcome this barrier. The main goal of this research study is to determine whether improvements in cardio-metabolic health can be realized by giving people pulse-based lunches and snacks to replace their regular workplace lunches and snacks. In this randomized controlled trial, 100 office workers from the University of Saskatchewan will participate in a cross-over study where they will be randomized into one of two diets for 2 months: Receive pre-packaged pulse-based lunches and snacks to replace their usual lunches/snacks during the work day OR to continue consuming their usual diets for two months. After a one-month washout, they will cross-over to the other condition. The primary outcome measure, Matsuda Index (determined by blood glucose and insulin responses to an oral glucose tolerance test), will be assessed before each diet phase and at the end (i.e. two months) of each diet phase. Secondary outcome measures (body composition, waist girth, lipids, blood pressure will also be assessed.
- Conditions
- Insulin Sensitivity
- Being tested
- Pulse-based diet, Regular diet
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse-based dietDietary supplement
Low Glycemic Index
Regular dietDietary supplement
Moderate Glycemic Index
| Study group | Role | What they receive |
|---|---|---|
| Low Glycemic Index | Experimental | Pulse-based diet Receives: Dietary Supplement: Pulse-based diet |
| Moderate Glycemic Index | Active comparator | Regular diet Receives: Dietary Supplement: Regular diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Matsuda Index determined by glucose and insulin response to oral glucose tolerance test
Measured: Change from baseline to 8 weeks
Secondary outcomes (13)
Glucose area under the curve
Glucose area under the curve from a 2-hour oral glucose tolerance test
Measured: Change from baseline to 8 weeks
Insulin area under the curve
Insulin area under the curve from a 2-hour oral glucose tolerance test
Measured: Change from baseline to 8 weeks
Fasting glucose
Fasting glucose
Measured: Change from baseline to 8 weeks
Fasting insulin
Fasting insulin
Measured: Change from baseline to 8 weeks
Low-density lipoprotein cholesterol
LDL-C from fasting blood samples
Measured: Change from baseline to 8 weeks
High-density lipoprotein cholesterol
HDL-C from fasting blood samples
Measured: Change from baseline to 8 weeks
Total cholesterol
Total cholesterol from fasting blood samples
Measured: Change from baseline to 8 weeks.
Triglycerides
Triglycerides from fasting blood samples
Measured: Change from baseline to 8 weeks
Waist Girth
Waist Girth
Measured: Change from baseline to 8 weeks
Fat mass
Fat mass from DXA measurements
Measured: Change from baseline to 8 weeks
Lean tissue mass
Lean tissue mass from DXA measurements
Measured: Change from baseline to 8 weeks
Systolic blood pressure
Systolic blood pressure measured at rest
Measured: Change from baseline to 8 weeks
Diastolic blood pressure
Diastolic blood pressure measured at rest
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start15 May 2019
- Primary completion15 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover: 1. Pulse-based diet; 2. Regular diet
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip Chilibeck, Ph.D., Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941704
- Sponsor's protocol ID
- 609
- Status last verified
- Oct 2021
- First submitted
- 6 May 2019
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertrand L, Shaw KA, Hood-Niefer S, Ko J, Gordon J, Zello GA, Chilibeck PD. Consumer Acceptability and Metabolic Health Benefits of Meals Containing Pulses (Chickpeas, Lentils, Peas) for Sedentary Office Workers. Foods. 2026 Sep 18;15(18):3302. doi: 10.3390/foods15183302.
PubMed 42794087
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Pre-Packaged Pulse-Based Meals to Ameliorate the Negative Health Consequences of Sedentary Behavior
- ClinicalTrials.gov ID
- NCT03941704
- Acronym / sponsor ID
- 609
- Conditions
- Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 May 2019 (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 hypothesis is that consumption of pulse-based foods (i.e. containing chickpeas, lentils, and split peas) during the workday will improve insulin sensitivity, glucose tolerance, blood lipids, body composition, and blood pressure in sedentary office workers.One-hundred office workers from a university campus will participate in a cross-over study where they will be randomized (i.e. assigned by chance) to receive pre-packaged pulse-based lunches and snacks to replace their usual lunches/snacks during the work day OR to continue consuming their usual diets for two months. After the first dietary intervention, they will undergo a 1-month "wash-out" and then participate in two months of the opposite dietary intervention. The main outcome to be assessed is change in glucose and insulin (i.e. blood sugar control) determined during an oral glucose tolerance test. Secondary outcomes include changes in body composition, lipids, and blood pressure.
During the pulse-based diet phases, participants will be supplied with a ready-to-eat lunch and two snacks to eat during each workday. These will contain a total of 150g/d dry weight (250g/d wet weight) pulses
Detailed description
Sedentary behaviour has been deemed the "new smoking" based on multiple and potent negative impacts on health. Moreover, sedentary behaviour is a strong predictor of type 2 diabetes risk and cardiovascular disease. Previous studies have show that pulse-based meals derived from lentils, beans, chickpeas, and peas are effective for alleviating risk factors associated with diabetes and cardiovascular disease in clinical populations including older adults, overweight and obese individuals, and women with polycystic ovary syndrome; however, to date, there have been no nutrition-based interventions for alleviating risk factors for diabetes specifically targeting office workers exposed to long periods of sitting. Although people are aware of the health benefits of pulses, a major barrier to increased consumption continues to be a lack of knowledge on how to prepare pulse-based meals. This proposed study is designed to overcome this barrier. The main goal of this research study is to determine whether improvements in cardio-metabolic health can be realized by giving people pulse-based lunches and snacks to replace their regular workplace lunches and snacks. In this randomized controlled trial, 100 office workers from the University of Saskatchewan will participate in a cross-over study where they will be randomized into one of two diets for 2 months: Receive pre-packaged pulse-based lunches and snacks to replace their usual lunches/snacks during the work day OR to continue consuming their usual diets for two months. After a one-month washout, they will cross-over to the other condition. The primary outcome measure, Matsuda Index (determined by blood glucose and insulin responses to an oral glucose tolerance test), will be assessed before each diet phase and at the end (i.e. two months) of each diet phase. Secondary outcome measures (body composition, waist girth, lipids, blood pressure will also be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover: 1. Pulse-based diet; 2. Regular diet
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Index | Experimental | Dietary Supplement: Pulse-based dietPulse-based diet |
| Moderate Glycemic Index | Active comparator | Dietary Supplement: Regular dietRegular diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and Women
- 18y or older
- Engaged in >5 hours per day sitting
Key exclusion criteria (4 listed)
- Diagnosed with diabetes
- taking glucose or lipid-lowering medication
- Regular consumers of pulses (1.5 cups (250g) or greater of pulses per week)
- Engaged in 60 minutes or greater of physical activity per day
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 |
|---|---|---|
| Pulse-based dietLow Glycemic Index | Dietary supplement | Low Glycemic Index |
| Regular dietModerate Glycemic Index | Dietary supplement | Moderate Glycemic Index |
Primary outcome
Insulin sensitivity
Time frame: Change from baseline to 8 weeks
Matsuda Index determined by glucose and insulin response to oral glucose tolerance test
13 secondary outcomes
Glucose area under the curve
Time frame: Change from baseline to 8 weeks
Insulin area under the curve
Time frame: Change from baseline to 8 weeks
Fasting glucose
Time frame: Change from baseline to 8 weeks
Fasting insulin
Time frame: Change from baseline to 8 weeks
Low-density lipoprotein cholesterol
Time frame: Change from baseline to 8 weeks
High-density lipoprotein cholesterol
Time frame: Change from baseline to 8 weeks
Total cholesterol
Time frame: Change from baseline to 8 weeks.
Triglycerides
Time frame: Change from baseline to 8 weeks
Waist Girth
Time frame: Change from baseline to 8 weeks
Fat mass
Time frame: Change from baseline to 8 weeks
Lean tissue mass
Time frame: Change from baseline to 8 weeks
Systolic blood pressure
Time frame: Change from baseline to 8 weeks
Diastolic blood pressure
Time frame: Change from baseline to 8 weeks
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 21 Oct 2021.
- Derived from this study: PubMed 42794087Bertrand L, Shaw KA, Hood-Niefer S, Ko J, Gordon J, Zello GA, Chilibeck PD. Consumer Acceptability and Metabolic Health Benefits of Meals Containing Pulses (Chickpeas, Lentils, Peas) for Sedentary Office Workers. Foods. 2026 Sep 18;15(18):3302. doi: 10.3390/foods15183302.
- Individual participant dataSharing planned: No
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Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
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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.
Philip Chilibeck, Ph.D. principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse-based diet and Regular diet in people with Insulin Sensitivity, run by University of Saskatchewan 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 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 21 Oct 2021. 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?
Insulin sensitivity (time frame: Change from baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941704, which also lists 1 linked publication.
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 21 Oct 2021.