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

Not Applicable

Completed

• Conditions: Hypertension; Pre-hypertension; Obesity
• Interventions: Other: Whole body vibration training & diet; Other: Hypocaloric diet; Other: Whole Body Vibration Training

• Registration Number: NCT01741779
• Lead Sponsor: Florida State University

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-12
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-03
• Study First Posted: 2012-12-05
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole body vibration training & diet	Whole body vibration training & diet	Lower-body exercise training on a vibration platform and diet
Hypocaloric diet	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.
Whole body vibration training	Whole Body Vibration Training	Lower-body exercises 3 times per wk for 12 wk in a vibration platform

Primary Outcome Measures

Name	Time	Method
Body Composition	12 weeks	By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
Pressure Wave Reflection	12 weeks	Using the augmentation index from radial tonometry
Blood pressure	12 weeks	Non-invasive measures of brachial and aortic blood pressure
Autonomic Function	12 weeks	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
Arterial Stiffness	12 weeks	Using pulse wave velocity of the aorta, systemic, and legs

Secondary Outcome Measures

Name	Time	Method
Endothelial Function	12 weeks	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)

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States