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

Obesity Clinical Trial

Official title:

The Effect of Diet and Whole-body Vibration Training on Cardiovascular and Autonomic Function in Obese Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741779
• Other study ID #: HSC2011.6728
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: December 3, 2012
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: December 2012
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypertension
• Obesity
• Pre-hypertension
• Prehypertension

Intervention

Other:
• 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).
• 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.
• Whole body vibration training & diet
Combination of whole body vibration training and hypocaloric diet

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	Nutrisystem, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition	By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference	12 weeks	No
Primary	Blood pressure	Non-invasive measures of brachial and aortic blood pressure	12 weeks	No
Primary	Arterial Stiffness	Using pulse wave velocity of the aorta, systemic, and legs	12 weeks	No
Primary	Pressure Wave Reflection	Using the augmentation index from radial tonometry	12 weeks	No
Primary	Autonomic Function	Heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and spontaneous baroreflex sensitivity will be assessed from electrocardiogram and beat-by-beat digital blood pressure	12 weeks	No
Secondary	Endothelial Function	By measuring circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NOx, 6-keto PGFIa, insulin, and ghrelin)and vasoconstrictors (ET-1 and 8-iso PGF2a, VEGF)	12 weeks	No