Low Sodium Diet and Behavioral Intervention for Reversing Arterial Stiffening in Overweight Individuals

Obesity Clinical Trial

— SAVE  

Official title:

Clinical Trial to Reverse Early Arterial Stiffening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366990
• Other study ID #: 415
• Secondary ID: 5R01HL077525
• Status: Completed
• Phase: N/A
• First received: August 18, 2006
• Last updated: March 5, 2016
• Start date: January 2007
• Est. completion date: June 2013

Study information

• Verified date: March 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Obese individuals are at risk for developing cardiovascular disease (CVD). Increasing physical activity, losing weight, and reducing sodium intake may reverse arterial stiffness and blood vessel damage that is linked to obesity. This study will evaluate the effectiveness of a low sodium diet and a behavioral weight loss intervention in reducing arterial stiffness in overweight young adults.

Description:

CVD includes diseases that affect the heart and blood vessels. Arterial stiffness, in which arteries harden and become less flexible, increases the risk of developing CVD. Arterial stiffness increases both with age and in certain disease states, including high blood pressure, diabetes, and obesity. Young adults who are obese prematurely place themselves at risk for developing arterial stiffness and CVD. Physical activity and weight loss may reverse arterial stiffness in these individuals. Reducing sodium intake, which has been proven to decrease blood pressure, may also improve blood vessel function and arterial stiffness. The purpose of this study is to evaluate the effectiveness of a low sodium diet and a behavioral weight loss intervention in reducing arterial stiffness in young, moderately overweight individuals.

Participants will first attend a baseline study visit, at which time blood will be collected, and height, weight, waist circumference, and blood pressure will be measured. Questionnaires to assess medical history, physical activity levels, and dietary habits will be completed. An ultrasound will be used to evaluate blood vessel function and arterial stiffness. All participants will then take part in a 12-month behavioral and dietary intervention. The intervention will emphasize increasing physical activity and decreasing caloric intake by modifying lifestyle choices, physical and social environments, and attitudes toward food and exercise. Participants will be randomly assigned to follow either a low sodium diet or a normal sodium diet. During Months 1 through 4, participants will attend weekly study visits for group counseling sessions; during Months 4 through 8, study visits will occur once every two weeks; and during Months 8 through 12, they will occur once a month. At each study visit, weight, waist circumference, and blood pressure will also be measured. If necessary, individual counseling sessions will be scheduled. Participants will also document daily physical activity and caloric intake in a diary. Baseline evaluations will be repeated at Months 6, 12, and 24.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: June 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) between 25 and 35

Exclusion Criteria:

• High blood pressure currently being treated with medication

• Blood pressure greater than or equal to 140/90 mm Hg on two consecutive study visits

• Diabetes, defined as either a fasting glucose test result of .126 or current use of hypoglycemic medications

• Currently taking hyperlipidemia medication

• Currently taking vasoactive medications

• History of known atherosclerotic disease (e.g., angina, heart attack, lower extremity arterial disease)

• Underlying inflammatory condition (e.g., systemic lupus erythematosus, rheumatoid arthritis)

• Chronic infection

• Current participation in a formal exercise or weight loss program

• Pregnant or planning to become pregnant during the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity

Intervention

Behavioral:
• Low Sodium Diet
Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics with a focus on lowering sodium intake.
• Regular Sodium Intake
Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (10)

Cooper JN, Buchanich JM, Youk A, Brooks MM, Barinas-Mitchell E, Conroy MB, Sutton-Tyrrell K. Reductions in arterial stiffness with weight loss in overweight and obese young adults: potential mechanisms. Atherosclerosis. 2012 Aug;223(2):485-90. doi: 10.101 — View Citation

Cooper JN, Evans RW, Mori Brooks M, Fried L, Holmes C, Barinas-Mitchell E, Sutton-Tyrrell K. Associations between arterial stiffness and platelet activation in normotensive overweight and obese young adults. Clin Exp Hypertens. 2014;36(3):115-22. doi: 10. — View Citation

Cooper JN, Fried L, Tepper P, Barinas-Mitchell E, Conroy MB, Evans RW, Mori Brooks M, Woodard GA, Sutton-Tyrrell K. Changes in serum aldosterone are associated with changes in obesity-related factors in normotensive overweight and obese young adults. Hype — View Citation

Cooper JN, Tepper P, Barinas-Mitchell E, Woodard GA, Sutton-Tyrrell K. Serum aldosterone is associated with inflammation and aortic stiffness in normotensive overweight and obese young adults. Clin Exp Hypertens. 2012;34(1):63-70. doi: 10.3109/10641963.20 — View Citation

Hawkins M, Gabriel KP, Cooper J, Storti KL, Sutton-Tyrrell K, Kriska A. The impact of change in physical activity on change in arterial stiffness in overweight or obese sedentary young adults. Vasc Med. 2014 May 30;19(4):257-263. [Epub ahead of print] — View Citation

Hughes TM, Althouse AD, Niemczyk NA, Hawkins MS, Kuipers AL, Sutton-Tyrrell K. Effects of weight loss and insulin reduction on arterial stiffness in the SAVE trial. Cardiovasc Diabetol. 2012 Sep 22;11:114. doi: 10.1186/1475-2840-11-114. — View Citation

Lee JJ, Woodard GA, Gianaros PJ, Barinas-Mitchell E, Tepper PG, Conroy MB. Ectopic adiposity is associated with autonomic risk factors and subclinical cardiovascular disease in young adults. Obesity (Silver Spring). 2015 Oct;23(10):2030-6. doi: 10.1002/ob — View Citation

Niemczyk NA, Catov JM, Barinas-Mitchell E, McClure CK, Roberts JM, Tepper PG, Sutton-Tyrrell K. Nulliparity is associated with less healthy markers of subclinical cardiovascular disease in young women with overweight and obesity. Obesity (Silver Spring). — View Citation

Njoroge JN, El Khoudary SR, Fried LF, Barinas-Mitchell E, Sutton-Tyrrell K. High urinary sodium is associated with increased carotid intima-media thickness in normotensive overweight and obese adults. Am J Hypertens. 2011 Jan;24(1):70-6. doi: 10.1038/ajh. — View Citation

Smith HA, Storti KL, Arena VC, Kriska AM, Gabriel KK, Sutton-Tyrrell K, Hames KC, Conroy MB. Associations between accelerometer-derived physical activity and regional adiposity in young men and women. Obesity (Silver Spring). 2013 Jun;21(6):1299-305. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness		Measured at Month 6	No
Secondary	Arterial stiffness and remodelling		Measured at Months 6, 12 and 24	No
Secondary	Endothelial function		Measured at Months 6, 12, and 24	No