Maintenance of Recommended Sodium Intake (SPICE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
McCormick Science Institute
Information provided by (Responsible Party):
Cheryl Anderson, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01615159
First received: April 16, 2012
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Maintenance of Recommended Sodium Intake
Behavioral: Behavior and lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Maintenance of Recommended Sodium Intake

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Change from baseline in urinary sodium excretion [ Time Frame: Weeks 4, 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in preferences for level of sodium in food products [ Time Frame: Weeks 4, 24 ] [ Designated as safety issue: No ]
  • % of people below 2300 mg/day sodium intake [ Time Frame: Weeks 4, 24 ] [ Designated as safety issue: No ]
  • % of people below 1500 mg/day sodium intake [ Time Frame: weeks 4, 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Self directed control
Active Comparator: Behavior and lifestyle counseling Behavioral: Behavior and lifestyle counseling
20 week intervention period where one group gets behavior and lifestyle counseling and the other group gets no active intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01615159

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
McCormick Science Institute
Investigators
Principal Investigator: Cheryl A Anderson, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Cheryl Anderson, Adjunct Associate Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01615159     History of Changes
Other Study ID Numbers: JHSPH4135
Study First Received: April 16, 2012
Last Updated: May 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Sodium
Diet
Urinary sodium excretion
Feeding study
Diet maintenance

ClinicalTrials.gov processed this record on July 26, 2014