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

Insulin Sensitivity Clinical Trial

Official title:

Development of Pre-Packaged Pulse-Based Meals to Ameliorate the Negative Health Consequences of Sedentary Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03941704
• Other study ID #: 609
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2021
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 30, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity

Intervention

Dietary Supplement:
• Pulse-based diet
Low Glycemic Index
• Regular diet
Moderate Glycemic Index

Locations

Country	Name	City	State
Canada	College of Kinesiology, University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Matsuda Index determined by glucose and insulin response to oral glucose tolerance test	Change from baseline to 8 weeks
Secondary	Glucose area under the curve	Glucose area under the curve from a 2-hour oral glucose tolerance test	Change from baseline to 8 weeks
Secondary	Insulin area under the curve	Insulin area under the curve from a 2-hour oral glucose tolerance test	Change from baseline to 8 weeks
Secondary	Fasting glucose	Fasting glucose	Change from baseline to 8 weeks
Secondary	Fasting insulin	Fasting insulin	Change from baseline to 8 weeks
Secondary	Low-density lipoprotein cholesterol	LDL-C from fasting blood samples	Change from baseline to 8 weeks
Secondary	High-density lipoprotein cholesterol	HDL-C from fasting blood samples	Change from baseline to 8 weeks
Secondary	Total cholesterol	Total cholesterol from fasting blood samples	Change from baseline to 8 weeks.
Secondary	Triglycerides	Triglycerides from fasting blood samples	Change from baseline to 8 weeks
Secondary	Waist Girth	Waist Girth	Change from baseline to 8 weeks
Secondary	Fat mass	Fat mass from DXA measurements	Change from baseline to 8 weeks
Secondary	Lean tissue mass	Lean tissue mass from DXA measurements	Change from baseline to 8 weeks
Secondary	Systolic blood pressure	Systolic blood pressure measured at rest	Change from baseline to 8 weeks
Secondary	Diastolic blood pressure	Diastolic blood pressure measured at rest	Change from baseline to 8 weeks