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Completed

NCT Number: NCT03941704

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, S7N5B2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse-based diet

Dietary Supplement

Low Glycemic Index

Regular diet

Dietary Supplement

Moderate Glycemic Index

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 8, 2019
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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