Clinical trial NCT01741779: Diet and Whole-body Vibration Training on Cardiovascular and Autonomic Function
Official title: The Effect of Diet and Whole-body Vibration Training on Cardiovascular and Autonomic Function in Obese Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Nutrisystem, Inc.
First posted: 2012-12-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Body Composition
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Arterial Stiffness
timeFrame: 12 weeks
measure: Pressure Wave Reflection
timeFrame: 12 weeks
measure: Autonomic Function
timeFrame: 12 weeks
Secondary outcomes:
measure: Endothelial Function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Arturo Figueroa, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: