Maintenance of Recommended Sodium Intake

NCT ID: NCT01615159

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Maintenance of Recommended Sodium Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Self directed control

Group Type NO_INTERVENTION

No interventions assigned to this group

Behavior and lifestyle counseling

Group Type ACTIVE_COMPARATOR

Behavior and lifestyle counseling

Intervention Type BEHAVIORAL

20 week intervention period where one group gets behavior and lifestyle counseling and the other group gets no active intervention

Interventions

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Behavior and lifestyle counseling

20 week intervention period where one group gets behavior and lifestyle counseling and the other group gets no active intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McCormick Science Institute

INDUSTRY

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheryl A Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26269371 (View on PubMed)

Other Identifiers

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JHSPH4135

Identifier Type: -

Identifier Source: org_study_id

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