Pulse-based Foods for Alleviation of Negative Consequences of Sedentary Behaviour
Primary Purpose
Insulin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pulse-based diet
Regular diet
Sponsored by

About this trial
This is an interventional prevention trial for Insulin Sensitivity
Eligibility Criteria
Inclusion Criteria:
- Men and Women
- 18y or older
- Engaged in >5 hours per day sitting
Exclusion Criteria:
- 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
Sites / Locations
- College of Kinesiology, University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low Glycemic Index
Moderate Glycemic Index
Arm Description
Pulse-based diet
Regular diet
Outcomes
Primary Outcome Measures
Insulin sensitivity
Matsuda Index determined by glucose and insulin response to oral glucose tolerance test
Secondary Outcome Measures
Glucose area under the curve
Glucose area under the curve from a 2-hour oral glucose tolerance test
Insulin area under the curve
Insulin area under the curve from a 2-hour oral glucose tolerance test
Fasting glucose
Fasting glucose
Fasting insulin
Fasting insulin
Low-density lipoprotein cholesterol
LDL-C from fasting blood samples
High-density lipoprotein cholesterol
HDL-C from fasting blood samples
Total cholesterol
Total cholesterol from fasting blood samples
Triglycerides
Triglycerides from fasting blood samples
Waist Girth
Waist Girth
Fat mass
Fat mass from DXA measurements
Lean tissue mass
Lean tissue mass from DXA measurements
Systolic blood pressure
Systolic blood pressure measured at rest
Diastolic blood pressure
Diastolic blood pressure measured at rest
Full Information
NCT ID
NCT03941704
First Posted
May 6, 2019
Last Updated
October 19, 2021
Sponsor
University of Saskatchewan
1. Study Identification
Unique Protocol Identification Number
NCT03941704
Brief Title
Pulse-based Foods for Alleviation of Negative Consequences of Sedentary Behaviour
Official Title
Development of Pre-Packaged Pulse-Based Meals to Ameliorate the Negative Health Consequences of Sedentary Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover: 1. Pulse-based diet; 2. Regular diet
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Glycemic Index
Arm Type
Experimental
Arm Description
Pulse-based diet
Arm Title
Moderate Glycemic Index
Arm Type
Active Comparator
Arm Description
Regular diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Pulse-based diet
Intervention Description
Low Glycemic Index
Intervention Type
Dietary Supplement
Intervention Name(s)
Regular diet
Intervention Description
Moderate Glycemic Index
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Matsuda Index determined by glucose and insulin response to oral glucose tolerance test
Time Frame
Change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Glucose area under the curve
Description
Glucose area under the curve from a 2-hour oral glucose tolerance test
Time Frame
Change from baseline to 8 weeks
Title
Insulin area under the curve
Description
Insulin area under the curve from a 2-hour oral glucose tolerance test
Time Frame
Change from baseline to 8 weeks
Title
Fasting glucose
Description
Fasting glucose
Time Frame
Change from baseline to 8 weeks
Title
Fasting insulin
Description
Fasting insulin
Time Frame
Change from baseline to 8 weeks
Title
Low-density lipoprotein cholesterol
Description
LDL-C from fasting blood samples
Time Frame
Change from baseline to 8 weeks
Title
High-density lipoprotein cholesterol
Description
HDL-C from fasting blood samples
Time Frame
Change from baseline to 8 weeks
Title
Total cholesterol
Description
Total cholesterol from fasting blood samples
Time Frame
Change from baseline to 8 weeks.
Title
Triglycerides
Description
Triglycerides from fasting blood samples
Time Frame
Change from baseline to 8 weeks
Title
Waist Girth
Description
Waist Girth
Time Frame
Change from baseline to 8 weeks
Title
Fat mass
Description
Fat mass from DXA measurements
Time Frame
Change from baseline to 8 weeks
Title
Lean tissue mass
Description
Lean tissue mass from DXA measurements
Time Frame
Change from baseline to 8 weeks
Title
Systolic blood pressure
Description
Systolic blood pressure measured at rest
Time Frame
Change from baseline to 8 weeks
Title
Diastolic blood pressure
Description
Diastolic blood pressure measured at rest
Time Frame
Change from baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and Women
18y or older
Engaged in >5 hours per day sitting
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Chilibeck, Ph.D.
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Kinesiology, University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N5B2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Pulse-based Foods for Alleviation of Negative Consequences of Sedentary Behaviour
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