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

NCT ID: NCT03941704

Last Updated: 2021-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2021-06-30

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.

Conditions

Insulin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Low Glycemic Index

Pulse-based diet

Group Type: EXPERIMENTAL

Pulse-based diet

Intervention Type: DIETARY_SUPPLEMENT

Low Glycemic Index

Moderate Glycemic Index

Regular diet

Group Type: ACTIVE_COMPARATOR

Regular diet

Intervention Type: DIETARY_SUPPLEMENT

Moderate Glycemic Index

Interventions

Pulse-based diet

Low Glycemic Index

Intervention Type: DIETARY_SUPPLEMENT

Regular diet

Moderate Glycemic Index

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Phil Chilibeck

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Chilibeck, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

609

Identifier Type: -

Identifier Source: org_study_id