Maintenance of Recommended Sodium Intake
SPICE
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedOctober 28, 2022
September 1, 2014
2.3 years
April 16, 2012
October 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in urinary sodium excretion
Weeks 4, 24
Secondary Outcomes (3)
Change from baseline in preferences for level of sodium in food products
Weeks 4, 24
Percentage of people below 2300 mg/day sodium intake
Weeks 4, 24
Percentage of people below 1500 mg/day sodium intake
weeks 4, 24
Study Arms (2)
Self directed control
NO INTERVENTIONBehavior and lifestyle counseling
ACTIVE COMPARATORInterventions
20 week intervention period where one group gets behavior and lifestyle counseling and the other group gets no active intervention
Eligibility Criteria
You may qualify if:
- Adults to whom the U.S. Dietary Guideline of \< 1500 mg/day of sodium applies
You may not qualify if:
- Individuals with chronic kidney disease,
- Chronic poor health state,
- Pregnancy,
- Inability to complete feeding study,
- Investigator discretion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Related Publications (1)
Anderson CA, Cobb LK, Miller ER 3rd, Woodward M, Hottenstein A, Chang AR, Mongraw-Chaffin M, White K, Charleston J, Tanaka T, Thomas L, Appel LJ. Effects of a behavioral intervention that emphasizes spices and herbs on adherence to recommended sodium intake: results of the SPICE randomized clinical trial. Am J Clin Nutr. 2015 Sep;102(3):671-9. doi: 10.3945/ajcn.114.100750. Epub 2015 Aug 12.
PMID: 26269371DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl A Anderson, PhD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2012
First Posted
June 8, 2012
Study Start
June 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
October 28, 2022
Record last verified: 2014-09