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Salt Sources Study

27 de janeiro de 2016 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Descrição detalhada

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 de estudo

Observacional

Inscrição (Real)

450

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 74 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Perspectivas de Tempo: Transversal

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Sodium intake as assessed through four 24 hour dietary recalls
Prazo: 11 days
Four 24-hour dietary recalls and duplicate collection of salt added at the table
11 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Discretionary sodium intake from salt added at the table and during cooking as assessed through duplicate salt collection
Prazo: 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
Prazo: 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.
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Lyn Steffen, PhD, MPH, RD, University of Minnesota

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2014

Conclusão Primária (Real)

1 de dezembro de 2014

Conclusão do estudo (Real)

1 de dezembro de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de junho de 2015

Primeira postagem (Estimativa)

18 de junho de 2015

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

28 de janeiro de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de janeiro de 2016

Última verificação

1 de janeiro de 2016

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 0920-0982

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

Descrição do plano IPD

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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