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

NCT00800033 | Completed Phase 3

• 1 other identifier: PRO0822
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; lipids; blood pressure; body composition

Outcome Measures

Primary Outcomes (1)

• Metabolic syndrome score

  baseline, 2 months, 3 months, 5 months

Secondary Outcomes (16)

• Plasma glucose

  baseline, 2 months, 3 months, 5 months

• Plasma insulin

  baseline, 2 months, 3 months, 5 months

• High density lipoproteins

  baseline, 2 months, 3 months, 5 months

• Triacylglycerol

  baseline, 2 months, 3 months, 5 months

• Waist circumference

  baseline, 2 months, 3 months, 5 months

Study Arms (4)

Aerobic exercise training

EXPERIMENTAL

Behavioral: Aerobic exercise training

Resistance exercise training

PLACEBO COMPARATOR

Behavioral: Aerobic exercise training

pulse diet

EXPERIMENTAL

Pulse based diet containing peas, lentils, and beans

Dietary Supplement: pulse based diet

Regular diet

NO INTERVENTION

Interventions

Aerobic exercise training BEHAVIORAL

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

Aerobic exercise training; Resistance exercise training

pulse based diet DIETARY_SUPPLEMENT

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)

pulse diet

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women over the age of 50y

You may not qualify if:

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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Philip D Chilibeck, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

CA (1)