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

• ClinicalTrials.gov Identifier: NCT03941704
• Recruitment Status: Recruiting
• First Posted: May 8, 2019
• Last Update Posted: June 12, 2020
• Sponsor: University of Saskatchewan
• Information provided by (Responsible Party): Phil Chilibeck, University of Saskatchewan

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

Condition or disease	Intervention/treatment	Phase
Insulin Sensitivity	Dietary Supplement: Pulse-based diet; Dietary Supplement: Regular diet	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Crossover: 1. Pulse-based diet; 2. Regular diet
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Development of Pre-Packaged Pulse-Based Meals to Ameliorate the Negative Health Consequences of Sedentary Behavior
• Actual Study Start Date: May 15, 2019
• Estimated Primary Completion Date: May 15, 2021
• Estimated Study Completion Date: June 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Insulin sensitivity [ Time Frame: Change from baseline to 8 weeks ]
   Matsuda Index determined by glucose and insulin response to oral glucose tolerance test

Secondary Outcome Measures :

1. Glucose area under the curve [ Time Frame: Change from baseline to 8 weeks ]
   Glucose area under the curve from a 2-hour oral glucose tolerance test
2. Insulin area under the curve [ Time Frame: Change from baseline to 8 weeks ]
   Insulin area under the curve from a 2-hour oral glucose tolerance test
3. Fasting glucose [ Time Frame: Change from baseline to 8 weeks ]
   Fasting glucose
4. Fasting insulin [ Time Frame: Change from baseline to 8 weeks ]
   Fasting insulin
5. Low-density lipoprotein cholesterol [ Time Frame: Change from baseline to 8 weeks ]
   LDL-C from fasting blood samples
6. High-density lipoprotein cholesterol [ Time Frame: Change from baseline to 8 weeks ]
   HDL-C from fasting blood samples
7. Total cholesterol [ Time Frame: Change from baseline to 8 weeks. ]
   Total cholesterol from fasting blood samples
8. Triglycerides [ Time Frame: Change from baseline to 8 weeks ]
   Triglycerides from fasting blood samples
9. Waist Girth [ Time Frame: Change from baseline to 8 weeks ]
   Waist Girth
10. Fat mass [ Time Frame: Change from baseline to 8 weeks ]
    Fat mass from DXA measurements
11. Lean tissue mass [ Time Frame: Change from baseline to 8 weeks ]
    Lean tissue mass from DXA measurements
12. Systolic blood pressure [ Time Frame: Change from baseline to 8 weeks ]
    Systolic blood pressure measured at rest
13. Diastolic blood pressure [ Time Frame: Change from baseline to 8 weeks ]
    Diastolic blood pressure measured at rest

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Philip Chilibeck, Ph.D.; 1-306-966-1072; phil.chilibeck@usask.ca

Contact: Julianne Gordon, M.Sc.; 1-306-966-1082; julianne.gordon@usask.ca

Locations

Canada, Saskatchewan

College of Kinesiology, University of Saskatchewan; Recruiting

Saskatoon, Saskatchewan, Canada, S7N5B2

Contact: Philip Chilibeck, Ph.D. 1-306-966-1072 phil.chilibeck@usask.ca

Contact: Julianne Gordon, M.Sc. 1-306-966-1082 julianne.gordon@usask.ca

Sub-Investigator: Gordon Zello, Ph.D.

Sponsors and Collaborators

University of Saskatchewan

Investigators

• Principal Investigator: Philip Chilibeck, Ph.D.; University of Saskatchewan

More Information

• Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan
• ClinicalTrials.gov Identifier: NCT03941704
• Other Study ID Numbers: 609
• First Posted: May 8, 2019
• Last Update Posted: June 12, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases