Clinical trial NCT03941704: 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
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover: 1. Pulse-based diet; 2. Regular diet
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Glucose area under the curve
timeFrame: Change from baseline to 8 weeks
measure: Insulin area under the curve
timeFrame: Change from baseline to 8 weeks
measure: Fasting glucose
timeFrame: Change from baseline to 8 weeks
measure: Fasting insulin
timeFrame: Change from baseline to 8 weeks
measure: Low-density lipoprotein cholesterol
timeFrame: Change from baseline to 8 weeks
measure: High-density lipoprotein cholesterol
timeFrame: Change from baseline to 8 weeks
measure: Total cholesterol
timeFrame: Change from baseline to 8 weeks.
measure: Triglycerides
timeFrame: Change from baseline to 8 weeks
measure: Waist Girth
timeFrame: Change from baseline to 8 weeks
measure: Fat mass
timeFrame: Change from baseline to 8 weeks
measure: Lean tissue mass
timeFrame: Change from baseline to 8 weeks
measure: Systolic blood pressure
timeFrame: Change from baseline to 8 weeks
measure: Diastolic blood pressure
timeFrame: Change from baseline to 8 weeks
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: College of Kinesiology, University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Philip Chilibeck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: