Pulse-based Foods for Alleviation of Negative Consequences of Sedentary Behaviour

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

Study Overview

• Status: Completed
• Conditions: Insulin Sensitivity
• Intervention / Treatment: Dietary supplement: Pulse-based diet; Dietary supplement: Regular diet

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N5B2
      • College of Kinesiology, University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Glycemic Index; Pulse-based diet	Dietary supplement: Pulse-based diet; Low Glycemic Index
Active Comparator: Moderate Glycemic Index; Regular diet	Dietary supplement: Regular diet; Moderate Glycemic Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity	Matsuda Index determined by glucose and insulin response to oral glucose tolerance test	Change from baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose area under the curve	Glucose area under the curve from a 2-hour oral glucose tolerance test	Change from baseline to 8 weeks
Insulin area under the curve	Insulin area under the curve from a 2-hour oral glucose tolerance test	Change from baseline to 8 weeks
Fasting glucose	Fasting glucose	Change from baseline to 8 weeks
Fasting insulin	Fasting insulin	Change from baseline to 8 weeks
Low-density lipoprotein cholesterol	LDL-C from fasting blood samples	Change from baseline to 8 weeks
High-density lipoprotein cholesterol	HDL-C from fasting blood samples	Change from baseline to 8 weeks
Total cholesterol	Total cholesterol from fasting blood samples	Change from baseline to 8 weeks.
Triglycerides	Triglycerides from fasting blood samples	Change from baseline to 8 weeks
Waist Girth	Waist Girth	Change from baseline to 8 weeks
Fat mass	Fat mass from DXA measurements	Change from baseline to 8 weeks
Lean tissue mass	Lean tissue mass from DXA measurements	Change from baseline to 8 weeks
Systolic blood pressure	Systolic blood pressure measured at rest	Change from baseline to 8 weeks
Diastolic blood pressure	Diastolic blood pressure measured at rest	Change from baseline to 8 weeks

Collaborators and Investigators

• Sponsor: University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No