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

NCT01741779 | Completed

• 1 other identifier: HSC2011.6728
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Body Composition

  By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference

  12 weeks

• Blood pressure

  Non-invasive measures of brachial and aortic blood pressure

  12 weeks

• Arterial Stiffness

  Using pulse wave velocity of the aorta, systemic, and legs

  12 weeks

• Pressure Wave Reflection

  Using the augmentation index from radial tonometry

  12 weeks

• 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

Secondary Outcomes (1)

• Endothelial Function

  12 weeks

Study Arms (4)

Hypocaloric diet

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Whole body vibration training & diet

EXPERIMENTAL

Lower-body exercise training on a vibration platform and diet

Other: Whole body vibration training & diet

Whole body vibration training

EXPERIMENTAL

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

Other: Whole Body Vibration Training

Interventions

Whole Body Vibration Training OTHER

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).

Whole body vibration training

Hypocaloric diet OTHER

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.

Hypocaloric diet

Whole body vibration training & diet OTHER

Combination of whole body vibration training and hypocaloric diet

Whole body vibration training & diet

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida State University: lead
• Nutrisystem, Inc.: collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Obesity; Prehypertension; Hypertension

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Arturo Figueroa, M.D., Ph.D

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

US (1)