Maintenance of Recommended Sodium IntakeSPICENCT01615159
Maintenance of Recommended Sodium Intake
A study testing Behavior and lifestyle counseling in people with Maintenance of Recommended Sodium Intake, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Maintenance of Recommended Sodium Intake
- What is being tested?
- Behavior and lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults to whom the U.S. Dietary Guideline of < 1500 mg/day of sodium applies
Who cannot join
- Individuals with chronic kidney disease,
- Chronic poor health state,
- Pregnancy,
- Inability to complete feeding study,
- Investigator discretion
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Maintenance of Recommended Sodium Intake
- Being tested
- Behavior and lifestyle counseling
- Keywords
- Sodium, Diet, Urinary sodium excretion, Feeding study, Diet maintenance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior and lifestyle counselingBehavioural
20 week intervention period where one group gets behavior and lifestyle counseling and the other group gets no active intervention
| Study group | Role | What they receive |
|---|---|---|
| Self directed control | No intervention | Not described |
| Behavior and lifestyle counseling | Active comparator | Not described Receives: Behavioral: Behavior and lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in urinary sodium excretion
Measured: Weeks 4, 24
Secondary outcomes (3)
Change from baseline in preferences for level of sodium in food products
Measured: Weeks 4, 24
Percentage of people below 2300 mg/day sodium intake
Measured: Weeks 4, 24
Percentage of people below 1500 mg/day sodium intake
Measured: weeks 4, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maintenance of Recommended Sodium IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- McCormick Science Institute
- Responsible party
- Sponsor
- Investigators
- Cheryl A Anderson, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615159
- Sponsor's protocol ID
- JHSPH4135
- Acronym
- SPICE
- Status last verified
- Sep 2014
- First submitted
- 16 Apr 2012
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26269371
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Recommended Sodium Intake
- ClinicalTrials.gov ID
- NCT01615159
- Acronym / sponsor ID
- SPICE / JHSPH4135
- Conditions
- Maintenance of Recommended Sodium Intake
- Keywords
- Sodium, Diet, Urinary sodium excretion, Feeding study, Diet maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- McCormick Science Institute
- Study start
- Jun 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self directed control | No intervention | – |
| Behavior and lifestyle counseling | Active comparator | Behavioral: Behavior and lifestyle counseling |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults to whom the U.S. Dietary Guideline of < 1500 mg/day of sodium applies
Key exclusion criteria (5 listed)
- Individuals with chronic kidney disease,
- Chronic poor health state,
- Pregnancy,
- Inability to complete feeding study,
- Investigator discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior and lifestyle counseling20 week intervention period where one group gets behavior and lifestyle counseling and the other group gets no active intervention | Behavioural | Behavior and lifestyle counseling |
Primary outcome
Change from baseline in urinary sodium excretion
Time frame: Weeks 4, 24
3 secondary outcomes
Change from baseline in preferences for level of sodium in food products
Time frame: Weeks 4, 24
Percentage of people below 2300 mg/day sodium intake
Time frame: Weeks 4, 24
Percentage of people below 1500 mg/day sodium intake
Time frame: weeks 4, 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Derived from this study: PubMed 26269371Anderson 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl A Anderson, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior and lifestyle counseling in people with Maintenance of Recommended Sodium Intake, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in urinary sodium excretion (time frame: Weeks 4, 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01615159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.