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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
History of Changes
  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
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 June 18, 2013