Overview

This trial is active, not recruiting.

Condition maintenance of recommended sodium intake
Treatment behavior and lifestyle counseling
Sponsor Johns Hopkins Bloomberg School of Public Health
Collaborator McCormick Science Institute
Start date June 2012
End date August 2013
Trial size 40 participants
Trial identifier NCT01615159, JHSPH4135

Summary

The overall objective of this study is to assist the general public in achieving and maintaining the currently recommended sodium intake of 1500 mg/day through a reduced sodium intervention that emphasizes spices and herbs. The investigators hypothesize that after four weeks of eating a controlled diet, individuals will acclimate and adhere to a reduced sodium intake of 1500 mg/day and their taste preferences will change. The investigators also hypothesize that individuals in a low sodium behavioral intervention will maintain greater adherence to a dietary sodium intake of ≤ 1500 mg/day than individuals in a self-directed control group.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
(Active Comparator)
behavior and lifestyle counseling
20 week intervention period where one group gets behavior and lifestyle counseling and the other group gets no active intervention

Primary Outcomes

Measure
Change from baseline in urinary sodium excretion
time frame: Weeks 4, 24

Secondary Outcomes

Measure
Change from baseline in preferences for level of sodium in food products
time frame: Weeks 4, 24
% of people below 2300 mg/day sodium intake
time frame: Weeks 4, 24
% of people below 1500 mg/day sodium intake
time frame: weeks 4, 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adults to whom the U.S. Dietary Guideline of < 1500 mg/day of sodium applies Exclusion Criteria: - Individuals with chronic kidney disease, - Chronic poor health state, - Pregnancy, - Inability to complete feeding study, - Investigator discretion

Additional Information

Official title Maintenance of Recommended Sodium Intake
Principal investigator Cheryl A Anderson, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health.