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

This study has been completed.
Sponsor:
Collaborator:
Nutrisystem, Inc.
Information provided by (Responsible Party):
Arturo Figueroa, Florida State University
ClinicalTrials.gov Identifier:
NCT01741779
First received: December 3, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Pre-hypertension
Hypertension
Other: Whole Body Vibration Training
Other: Hypocaloric diet
Other: Whole body vibration training & diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Diet and Whole-body Vibration Training on Cardiovascular and Autonomic Function in Obese Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Florida State University:

Primary Outcome Measures:
  • Body Composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference

  • Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Non-invasive measures of brachial and aortic blood pressure

  • Arterial Stiffness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Using pulse wave velocity of the aorta, systemic, and legs

  • Pressure Wave Reflection [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Using the augmentation index from radial tonometry

  • Autonomic Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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)


Enrollment: 60
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.
No Intervention: Control
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.
Experimental: Whole body vibration training & diet
Lower-body exercise training on a vibration platform and diet
Other: Whole body vibration training & diet
Combination of whole body vibration training and hypocaloric diet
Experimental: Whole body vibration training
Lower-body exercises 3 times per wk for 12 wk in a vibration platform
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).

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

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741779

Locations
United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
Nutrisystem, Inc.
Investigators
Principal Investigator: Arturo Figueroa, M.D., Ph.D Florida State University
  More Information

No publications provided

Responsible Party: Arturo Figueroa, Associate Professor, Florida State University
ClinicalTrials.gov Identifier: NCT01741779     History of Changes
Other Study ID Numbers: HSC2011.6728
Study First Received: December 3, 2012
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Florida State University:
hypocaloric diet
whole body vibration training
prehypertension
hypertension
obesity
arterial function
arterial stiffness
pulse wave velocity
autonomic function
endothelial function
adipocytokines

Additional relevant MeSH terms:
Hypertension
Obesity
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014