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

Primary Purpose

Obesity, Pre-hypertension, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole Body Vibration Training
Hypocaloric diet
Whole body vibration training & diet
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring whole body vibration training, hypocaloric diet, prehypertension, hypertension, obesity, arterial function, arterial stiffness, pulse wave velocity, autonomic function, endothelial function, adipocytokines

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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)

Sites / Locations

  • Florida State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

Experimental

Arm Label

Hypocaloric diet

Control

Whole body vibration training & diet

Whole body vibration training

Arm 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.

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.

Lower-body exercise training on a vibration platform and diet

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
December 3, 2012
Last Updated
December 3, 2012
Sponsor
Florida State University
Collaborators
Nutrisystem, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01741779
Brief Title
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

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
Nutrisystem, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypocaloric diet
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
Whole body vibration training & diet
Arm Type
Experimental
Arm Description
Lower-body exercise training on a vibration platform and diet
Arm Title
Whole body vibration training
Arm Type
Experimental
Arm Description
Lower-body exercises 3 times per wk for 12 wk in a vibration platform
Intervention Type
Other
Intervention Name(s)
Whole Body Vibration Training
Intervention Description
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
Intervention Name(s)
Hypocaloric diet
Intervention Description
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
Intervention Name(s)
Whole body vibration training & diet
Intervention Description
Combination of whole body vibration training and hypocaloric diet
Primary Outcome Measure Information:
Title
Body Composition
Description
By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
Time Frame
12 weeks
Title
Blood pressure
Description
Non-invasive measures of brachial and aortic blood pressure
Time Frame
12 weeks
Title
Arterial Stiffness
Description
Using pulse wave velocity of the aorta, systemic, and legs
Time Frame
12 weeks
Title
Pressure Wave Reflection
Description
Using the augmentation index from radial tonometry
Time Frame
12 weeks
Title
Autonomic Function
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Endothelial Function
Description
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)
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Figueroa, M.D., Ph.D
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

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

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