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Maintenance of Recommended Sodium Intake (SPICE)

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ClinicalTrials.gov Identifier: NCT01615159
Recruitment Status : Unknown
Verified May 2013 by Cheryl Anderson, Johns Hopkins Bloomberg School of Public Health.
Recruitment status was:  Active, not recruiting
First Posted : June 8, 2012
Last Update Posted : May 13, 2013
Sponsor:
Collaborator:
McCormick Science Institute
Information provided by (Responsible Party):
Cheryl Anderson, Johns Hopkins Bloomberg School of Public Health

Brief 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.

Condition or disease Intervention/treatment Phase
Maintenance of Recommended Sodium Intake Behavioral: Behavior and lifestyle counseling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Maintenance of Recommended Sodium Intake
Study Start Date : June 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : February 2014

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline in urinary sodium excretion [ Time Frame: Weeks 4, 24 ]

Secondary Outcome Measures :
  1. Change from baseline in preferences for level of sodium in food products [ Time Frame: Weeks 4, 24 ]
  2. % of people below 2300 mg/day sodium intake [ Time Frame: Weeks 4, 24 ]
  3. % of people below 1500 mg/day sodium intake [ Time Frame: weeks 4, 24 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013

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