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Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Aerobic exercise training
pulse based diet
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring metabolic syndrome, lipids, blood pressure, body composition

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • men and women over the age of 50y

Exclusion Criteria:

  • allergies to beans, peas, lentils, chickpeas
  • currently taking medication for blood lipids
  • currently engaged in vigorous aerobic activity greater than 2 times per week

Sites / Locations

  • College of Kinesiology, University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

No Intervention

Arm Label

Aerobic exercise training

Resistance exercise training

pulse diet

Regular diet

Arm Description

Pulse based diet containing peas, lentils, and beans

Outcomes

Primary Outcome Measures

Metabolic syndrome score

Secondary Outcome Measures

Plasma glucose
Plasma insulin
High density lipoproteins
Triacylglycerol
Waist circumference
C-reactive protein
Lean body mass
Fat mass
Whole body bone mineral
Hip bone mineral
Lumbar spine bone mineral
Low density lipoproteins
Total cholesterol
Blood Pressure
Aerobic fitness - modified Canadian Test of Fitness
Strength

Full Information

First Posted
November 26, 2008
Last Updated
May 26, 2015
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT00800033
Brief Title
Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome
Official Title
Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators specific objective is to determine the effectiveness of a pulse-based diet combined with an exercise training program for reducing the risk of metabolic syndrome in older adults. The metabolic syndrome is a cluster of risk factors that predispose one to the development of diabetes and cardiovascular disease. These risk factors include increased abdominal obesity, high blood triglyceride levels, low blood high-density lipoproteins, high blood pressure, high blood glucose and insulin levels, and increased inflammation. The investigators hypothesize that a pulse-based diet combined with exercise training will be very effective for reducing the risks of the metabolic syndrome because each intervention acts on different components of the metabolic syndrome. The design will involve a randomized single-blind cross-over for the pulse-based diet, and a single blind randomized parallel group assignment for the exercise-based intervention. 100 subjects will be randomized to receive the pulse-based diet or their regular diet for 2 months and then cross-over to receive the opposite diet for 2 months, separated by a one-month "wash out". Subjects will be further randomized to exercise or "exercise placebo" groups for the duration of the trial (i.e. 5 months). The exercise intervention will involve aerobic training as this is most effective for reducing metabolic syndrome risk. Dependent variables will be measured at 4 time points: baseline, after the first 2-month diet, before the second 2-month diet (i.e. after the washout) and at the end of the second 2-month diet. These variables will include: Serum triglycerides, high density lipoproteins, C-reactive protein (as an inflammatory marker), glucose, and insulin, trunk body fat, and blood pressure. A composite metabolic syndrome score will be determined by converting each of these variables into Z-scores and determining the mean of these Z-scores. Secondary variables will include other serum lipids, including low density lipoproteins and total cholesterol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
metabolic syndrome, lipids, blood pressure, body composition

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise training
Arm Type
Experimental
Arm Title
Resistance exercise training
Arm Type
Placebo Comparator
Arm Title
pulse diet
Arm Type
Experimental
Arm Description
Pulse based diet containing peas, lentils, and beans
Arm Title
Regular diet
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise training
Intervention Description
Walking, jogging, rowing, cycling to be done 5 times per week for 45 minutes per session (3 supervised sessions, 2 sessions at home) for 5 months
Intervention Type
Dietary Supplement
Intervention Name(s)
pulse based diet
Intervention Description
Two pulse-based meals per day (lentils, beans, chickpeas, or peas) for 2 months, followed by 1-month washout and then a normal diet for 2 months (order of diets is randomized)
Primary Outcome Measure Information:
Title
Metabolic syndrome score
Time Frame
baseline, 2 months, 3 months, 5 months
Secondary Outcome Measure Information:
Title
Plasma glucose
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Plasma insulin
Time Frame
baseline, 2 months, 3 months, 5 months
Title
High density lipoproteins
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Triacylglycerol
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Waist circumference
Time Frame
baseline, 2 months, 3 months, 5 months
Title
C-reactive protein
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Lean body mass
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Fat mass
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Whole body bone mineral
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Hip bone mineral
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Lumbar spine bone mineral
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Low density lipoproteins
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Total cholesterol
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Blood Pressure
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Aerobic fitness - modified Canadian Test of Fitness
Time Frame
baseline, 2 months, 3 months, 5 months
Title
Strength
Time Frame
baseline, 2 months, 3 months, 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: men and women over the age of 50y Exclusion Criteria: allergies to beans, peas, lentils, chickpeas currently taking medication for blood lipids currently engaged in vigorous aerobic activity greater than 2 times per week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip D Chilibeck, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Kinesiology, University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5B2
Country
Canada

12. IPD Sharing Statement

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Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome

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