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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800033
• Other study ID #: PRO0822
• Status: Completed
• Phase: Phase 3
• First received: November 26, 2008
• Last updated: May 26, 2015
• Start date: November 2008
• Est. completion date: January 2010

Study information

• Verified date: May 2015
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• Aerobic exercise training
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

Dietary Supplement:
• pulse based diet
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)

Locations

Country	Name	City	State
Canada	College of Kinesiology, University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic syndrome score		baseline, 2 months, 3 months, 5 months	No
Secondary	Plasma glucose		baseline, 2 months, 3 months, 5 months	No
Secondary	Plasma insulin		baseline, 2 months, 3 months, 5 months	No
Secondary	High density lipoproteins		baseline, 2 months, 3 months, 5 months	No
Secondary	Triacylglycerol		baseline, 2 months, 3 months, 5 months	No
Secondary	Waist circumference		baseline, 2 months, 3 months, 5 months	No
Secondary	C-reactive protein		baseline, 2 months, 3 months, 5 months	No
Secondary	Lean body mass		baseline, 2 months, 3 months, 5 months	No
Secondary	Fat mass		baseline, 2 months, 3 months, 5 months	No
Secondary	Whole body bone mineral		baseline, 2 months, 3 months, 5 months	No
Secondary	Hip bone mineral		baseline, 2 months, 3 months, 5 months	No
Secondary	Lumbar spine bone mineral		baseline, 2 months, 3 months, 5 months	No
Secondary	Low density lipoproteins		baseline, 2 months, 3 months, 5 months	No
Secondary	Total cholesterol		baseline, 2 months, 3 months, 5 months	No
Secondary	Blood Pressure		baseline, 2 months, 3 months, 5 months	No
Secondary	Aerobic fitness - modified Canadian Test of Fitness		baseline, 2 months, 3 months, 5 months	No
Secondary	Strength		baseline, 2 months, 3 months, 5 months	No