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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02474693
Salt Sources Study
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
- Minneapolis, Minnesota
- Birmingham, Alabama; Palo Alto, California
Exclusion Criteria:
- pregnant
- breastfeeding
- have diabetes insipidus
- have chronic kidney disease.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Prospettive temporali: Trasversale
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sodium intake as assessed through four 24 hour dietary recalls
Lasso di tempo: 11 days
|
Four 24-hour dietary recalls and duplicate collection of salt added at the table
|
11 days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Discretionary sodium intake from salt added at the table and during cooking as assessed through duplicate salt collection
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Lyn Steffen, PhD, MPH, RD, University of Minnesota
Pubblicazioni e link utili
Pubblicazioni generali
- Quader ZS, Zhao L, Harnack LJ, Gardner CD, Shikany JM, Steffen LM, Gillespie C, Moshfegh A, Cogswell ME. Self-Reported Measures of Discretionary Salt Use Accurately Estimated Sodium Intake Overall but not in Certain Subgroups of US Adults from 3 Geographic Regions in the Salt Sources Study. J Nutr. 2019 Sep 1;149(9):1623-1632. doi: 10.1093/jn/nxz110.
- Harnack LJ, Cogswell ME, Shikany JM, Gardner CD, Gillespie C, Loria CM, Zhou X, Yuan K, Steffen LM. Sources of Sodium in US Adults From 3 Geographic Regions. Circulation. 2017 May 9;135(19):1775-1783. doi: 10.1161/CIRCULATIONAHA.116.024446.
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 0920-0982
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .