Diet and Whole-body Vibration Training on Cardiovascular and Autonomic Function

NCT ID: NCT01741779

Last Updated: 2012-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-04-30

Brief Summary

Obesity is a major risk factor for premature arterial abnormalities including high blood pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle modifications is associated with a decrease in large artery (aorta) stiffness. However, along with decreases in fat mass, hypocaloric diet reduces muscle mass. Whole body vibration results in similar increases in muscle mass and strength than those observed after resistance exercise and is feasible for special populations such as the obese and the elderly.

The investigators hypothesis is that weight loss via diet combined with whole body vibration training would additively reduce arterial stiffness and blood pressure in obese women. The investigators also hypothesize that the improved arterial function with weight loss would be associated with beneficial changes in the main mechanisms involved in BP regulation.

Detailed Description

The purpose of the study is to examine the effects of 12 weeks of whole body vibration training (WBVT) and diet on arterial function, autonomic function, and body composition in obese women. Specific aims of the study are to:

To evaluate the extent to which diet and (WBVT) will improve body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference.

To investigate that combined diet and (WBVT) are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic BP and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and baroreflex sensitivity). Flow mediated dilation and circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites [NOx], 6-keto PGFIa, insulin, and ghrelin) and vasoconstrictors (endothelin-1 [ET-1],8-iso PGF2a,vascular endothelium growth factor [VGEF]) will be assessed as secondary outcome variables.

Conditions

Obesity; Pre-hypertension; Hypertension

Keywords

whole body vibration training; hypocaloric diet; prehypertension; hypertension; obesity; arterial function; arterial stiffness; pulse wave velocity; autonomic function; endothelial function; adipocytokines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Hypocaloric diet

This arm involves 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day.

Group Type: EXPERIMENTAL

Hypocaloric diet

Intervention Type: OTHER

The hypocaloric diet intervention consists of 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day.

Control

This arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 12 wk.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Whole body vibration training & diet

Lower-body exercise training on a vibration platform and diet

Group Type: EXPERIMENTAL

Whole body vibration training & diet

Intervention Type: OTHER

Combination of whole body vibration training and hypocaloric diet

Whole body vibration training

Lower-body exercises 3 times per wk for 12 wk in a vibration platform

Group Type: EXPERIMENTAL

Whole Body Vibration Training

Intervention Type: OTHER

The Whole body vibration training intervention consists of lower-body exercise in a vibration platform 3 times per wk for 12 wk. The subjects will perform static and dynamic exercises for the legs on the vibration platform. Dynamic exercises will be performed with slow controlled movements starting from an upright position into a 60 degree knee flexion (squat) and maximal heel elevation (toestand). Static exercises will be performed without movement in the joint angles described previously. The training volume will increase progressively over the 12-week training period by increasing the intensity of vibration, duration of the exercise set (30-60 sec), number of sets per exercise, and total duration of the training session, and decreasing the duration of rest periods (30-60 sec).The intensity of vibration and amplitude will also be increased progressively (25-30 Hz of frequency and from low to high amplitude).

Interventions

Whole Body Vibration Training

The Whole body vibration training intervention consists of lower-body exercise in a vibration platform 3 times per wk for 12 wk. The subjects will perform static and dynamic exercises for the legs on the vibration platform. Dynamic exercises will be performed with slow controlled movements starting from an upright position into a 60 degree knee flexion (squat) and maximal heel elevation (toestand). Static exercises will be performed without movement in the joint angles described previously. The training volume will increase progressively over the 12-week training period by increasing the intensity of vibration, duration of the exercise set (30-60 sec), number of sets per exercise, and total duration of the training session, and decreasing the duration of rest periods (30-60 sec).The intensity of vibration and amplitude will also be increased progressively (25-30 Hz of frequency and from low to high amplitude).

Intervention Type: OTHER

Hypocaloric diet

The hypocaloric diet intervention consists of 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day.

Intervention Type: OTHER

Whole body vibration training & diet

Combination of whole body vibration training and hypocaloric diet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Female
• 45 to 65 years of age
• At least 1 year after menopause
• Body mass index of 27-39.9
• Sedentary or low active (less than 2 hr per wk)

Exclusion Criteria

• Younger than 45 or older than 65 years of age
• Body mass index lower than 27, or 40 or higher
• Physically active or competitively active
• Smoker
• Use of hormone replacement therapy of less than 1 yr
• Use of calcium channel blocker or beta blockers
• Use dietary supplementations (e.g.,L-arginine,L-citrulline,antioxidants)
• Uncontrolled diabetes
• Any restriction that would significantly interfere with compliance with the diet (e.g., allergy to nuts or dairy, or need to avoid soy)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nutrisystem, Inc.

INDUSTRY

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Arturo Figueroa

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arturo Figueroa, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Florida State University

Tallahassee, Florida, United States

Countries

United States

Other Identifiers

HSC2011.6728

Identifier Type: -

Identifier Source: org_study_id