Salt Sources Study

January 27, 2016 updated by: Mary Cogswell

Assessment of the Proportion of Sodium Intake From a Variety of Sources - Salt Sources Study

The Centers for Disease Control and Prevention conducted an observational cross-sectional study to obtain information about the amount of sodium consumed from various sources (including sodium from processed and restaurant foods, sodium inherent in foods, and salt added at the table and during cooking) and to examine variability across population subgroups. Data collection will include an observational component as well as a sub-study designed to refine the accuracy of estimates of total sodium intake and discretionary sodium intake.

Information was collected in three distinct geographic regions: 1) Minneapolis/St. Paul, Minnesota, 2) Birmingham, Alabama, and 3) Palo Alto, California. Over a two-year period, a study center in each location recruited 150 participants (total N=450). Overall, an approximately equal number of adults ages 18-74 years by approximately 10-year age groups in each sex-race group, including whites, blacks, Hispanics, and Asians. A sub-study was conducted among a subgroup of 150 of these participants (50 per site). University of Minnesota serves as a study coordinating center.

Study Overview

Status

Completed

Detailed Description

The Centers for Disease Control and Prevention conducted an observational cross-sectional study to obtain information about the amount of sodium consumed from various sources (including sodium from processed and restaurant foods, sodium inherent in foods, and salt added at the table and during cooking) and to examine variability across population subgroups. Data collection will include an observational component as well as a sub-study designed to refine the accuracy of estimates of total sodium intake and discretionary sodium intake.

Information was collected in three distinct geographic regions: 1) Minneapolis/St. Paul, Minnesota, 2) Birmingham, Alabama, and 3) Palo Alto, California. Over a two-year period, a study center in each location recruited 150 participants (total N=450). Overall, an approximately equal number of adults ages 18-74 years by approximately 10-year age groups in each sex-race group, including whites, blacks, Hispanics, and Asians. A sub-study was conducted among a subgroup of 150 of these participants (50 per site). University of Minnesota serves as a study coordinating center.

After informed consent and completing a screening process, each participant completed a personal questionnaire, a tap water questionnaire, four 24-hour dietary recalls, and four qualitative food records. In addition, height and weight information on each participant were collected, and each participant collected duplicate portions of their cooking/table salt. A few participants at each site also provided water samples analyzed to produce estimates of the amount of sodium in private sources of tap water.

The Salt Sources Study also included a sub-study to help determine the accuracy of estimates of total sodium intake and discretionary salt intake. About 25 participants at each site used a Study Salt for 11 days instead of their own household salt, provide additional information based on four 24-hour urine collections, four follow-up urine collection questionnaires, and three follow-up questionnaires on Study Salt use. The Study Salt has the same amount of sodium and contains a very small amount of lithium, a metal found in trace amounts in all plants and animals and excreted in urine. Participants are instructed to use the study salt as they would their salt at home and to collect duplicate samples of the amount used at the table and during home cooking. The amount of lithium excreted in the 24-hour urine collection is measured to assess the amount of sodium consumed from discretionary salt use (salt used at the table and during home cooking).

Results from the Salt Sources Study will be used to inform public health strategies to reduce sodium intake, determine if substantial variability in sources of sodium intake exists by social and demographic subgroups, and better inform estimates of salt added at the table used in Healthy People 2020 objectives related to sodium reduction.

Study Type

Observational

Enrollment (Actual)

450

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 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A convenience sample of adults aged 18-74 years, able to read and speak English, who have a telephone. Respondents will be excluded if they are pregnant, breastfeeding, have diabetes insipidus, or have chronic kidney disease. Information will be collected from the study participants in three study sites in Minnesota, Alabama, and California.

Description

Inclusion Criteria:

  • able to read and speak English, who have a telephone
  • live in one of three study sites in the following cities or surrounding geographic areas

    1. Minneapolis, Minnesota
    2. Birmingham, Alabama; Palo Alto, California

Exclusion Criteria:

  • pregnant
  • breastfeeding
  • have diabetes insipidus
  • have chronic kidney disease.

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

  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sodium intake as assessed through four 24 hour dietary recalls
Time Frame: 11 days
Four 24-hour dietary recalls and duplicate collection of salt added at the table
11 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discretionary sodium intake from salt added at the table and during cooking as assessed through duplicate salt collection
Time Frame: 11 days
Collection of duplicated samples of salt added at the table and during cooking on 24-h diet recall days
11 days
Total sodium intake as assessed through laboratory analysis 24-h urine collections
Time Frame: 11 days
Measured from four 24-hour urine collections in a subset of 150 study participants
11 days
Discretionary sodium intake (from salt added at the table or during cooking) assessed from the amount of lithium excreted in 24-hour urine collections.
Time Frame: 11 days
Measured from 24-hour urine collections in a subset of 150 study participants who used lithium labeled salt at the table and for home cooking in place of their usual salt
11 days

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Lyn Steffen, PhD, MPH, RD, University of Minnesota

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.

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

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 0920-0982

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

When data cleaning is completed, data can be obtained through submission of a proposal to the proposal and publication committee through contacting one of the investigators

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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