Maintenance of Recommended Sodium Intake (SPICE)

October 27, 2022 updated by: Johns Hopkins Bloomberg School of Public Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in urinary sodium excretion
Time Frame: Weeks 4, 24
Weeks 4, 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in preferences for level of sodium in food products
Time Frame: Weeks 4, 24
Weeks 4, 24
Percentage of people below 2300 mg/day sodium intake
Time Frame: Weeks 4, 24
Weeks 4, 24
Percentage of people below 1500 mg/day sodium intake
Time Frame: weeks 4, 24
weeks 4, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

McCormick Science Institute

Investigators

  • Principal Investigator: Cheryl A Anderson, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Actual)

October 28, 2022

Last Update Submitted That Met QC Criteria

October 27, 2022

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JHSPH4135

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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