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

Florida State University

Status

Completed

Conditions

Hypertension

Pre-hypertension

Obesity

Treatments

Other: Whole Body Vibration Training

Other: Whole body vibration training & diet

Other: Hypocaloric diet

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01741779

HSC2011.6728

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 4 patient groups

Hypocaloric diet

Experimental group

Description:

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.

Treatment:

Other: Hypocaloric diet

Control

No Intervention group

Description:

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.

Whole body vibration training & diet

Experimental group

Description:

Lower-body exercise training on a vibration platform and diet

Treatment:

Other: Whole body vibration training & diet