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

NCT03941704 | Completed

• 1 other identifier: 609
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Matsuda Index determined by glucose and insulin response to oral glucose tolerance test

  Change from baseline to 8 weeks

Secondary Outcomes (13)

• Glucose area under the curve

  Change from baseline to 8 weeks

• Insulin area under the curve

  Change from baseline to 8 weeks

• Fasting glucose

  Change from baseline to 8 weeks

• Fasting insulin

  Change from baseline to 8 weeks

• Low-density lipoprotein cholesterol

  Change from baseline to 8 weeks

Study Arms (2)

Low Glycemic Index

EXPERIMENTAL

Pulse-based diet

Dietary Supplement: Pulse-based diet

Moderate Glycemic Index

ACTIVE COMPARATOR

Regular diet

Dietary Supplement: Regular diet

Interventions

Pulse-based diet DIETARY_SUPPLEMENT

Low Glycemic Index

Low Glycemic Index

Regular diet DIETARY_SUPPLEMENT

Moderate Glycemic Index

Moderate Glycemic Index

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women
• y or older
• Engaged in \>5 hours per day sitting

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, S7N5B2, Canada

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Diet

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Philip Chilibeck, Ph.D.

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Crossover: 1. Pulse-based diet; 2. Regular diet

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: May 15, 2019
• Primary Completion: May 15, 2021
• Study Completion: June 30, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)