RBR-2ph4f9 Impact of dietary fiber supplementation on blood pressure inflammation in nutritional status and methylation of the…

Date of registration: 04/22/2019 ^(mm/dd/yyyy)
Last approval date : 04/22/2019 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1220-4046

• Public title:

  en

  Impact of dietary fiber supplementation on blood pressure inflammation in nutritional status and methylation of the aducin gene in adult women

  pt-br

  Impacto do suplemento da fibra dietetica na pressao arterial inflamacao estado nutricional e metilacao do gene aducina em mulheres adultas

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 64573917.4.0000.5188
    Issuing authority: Plataforma Brasil
  • 2.035.836
    Issuing authority: Comitê de Ética em Pesquisa do Centro de Ciências da Saúde da Universidade Federal da Paraíba

Sponsors

• Primary sponsor: Universidade Federal da Paraíba
• Secondary sponsor:
  • Institution: Universidade Federal da Paraíba
• Supporting source:
  • Institution: Universidade Federal da Paraíba

Health conditions

• Health conditions:

  en

  Essential hypertension (primary)

  pt-br

  Hipertensao essencial (primaria)

• General descriptors for health conditions:

  en

  I00-I99 IX - Diseases of the circulatory system

  pt-br

  I00-I99 IX - Doenças do aparelho circulatório

• Specific descriptors:

Interventions

• Interventions:

  en

  There will be 4 groups for a total of 60 women, where in the first group (G1) 20 normotensive women will use sachets with placebo (starch); in the second group (G2) 20 normotensive women will receive sachets with soluble and insoluble fibers (14g, being 60% soluble and 40% insoluble); in group three (G3) 20 hypertensive women will be treated with placebo (starch) and in group four (G4) 20 hypertensive women will receive sachets with soluble and insoluble fibers (14g being 60% soluble and 40% insoluble). All participants will be instructed to take the sanches for 8 weeks.

  pt-br

  Serao 4 grupos perfazendo um total de 60 mulheres, onde, no primeiro grupo (G1) 20 mulheres normotensas utilizarao sache com placebo (amido); no segundo grupo (G2) 20 mulheres normotensas receberao saches com fibras soluveis e insoluveis (14g, sendo sendo 60% soluveis e 40% insoluveis); no grupo três (G3) 20 mulheres hipertensas ulilizarao sache com placebo (amido) e, no grupo quatro (G4) 20 mulheres hipertensas receberao saches com fibras soluveis e insoluveis (14g, sendo sendo 60% soluveis e 40% insoluveis). Todas as participantes serão orientadas a tomar os sanches durante 8 semanas.

• Descriptors:

  en

  SP6.051.227 Supplementary Feeding

  pt-br

  SP6.051.227 Suplementação Alimentar

  es

  SP6.051.227 Alimentación Suplementaria

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 02/05/2018 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  60	F	20 Y	60 Y

• Inclusion criteria:

  en

  Voluntary women presenting with arterial hypertension or women without arterial hypertension aged between 20 and 60 years who do not present with serious cardiac diseases, renal, hepatic or serious psychiatric deficiencies.

  pt-br

  Mulheres voluntarias que apresentem hipertensao arterial ou mulheres sem hipertensao arterial com idade entre 20 e 60 anos, que nao apresentem doenças cardiacas graves, renais, hepaticas ou deficiencias psiquiatricas graves.

• Exclusion criteria:

  en

  Women under the age of 20 and over 60 years; who have severe cardiac, renal, liver and serious psychiatric illness.

  pt-br

  Mulheres com idade inferior a 20 anos e superior a 60 anos; que apresentem doenças graves cardiacas, renais, hepaticas e que apresentem doenças psiquicas graves.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	4	Double-blind	Non-randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Reduction of pressure levels by 20%, after 8 weeks of intervention in the treatment group, verified by indirect measurement of arterial pressure.

  pt-br

  Reducao dos niveis pressoricos em 20%, apos 8 semanas de intervencao no grupo tratamento, verificado por medida indireta da pressao arterial.

• Secondary outcomes:

  en

  Secondary outcomes are not expected

  pt-br

  Não são esperados desfechos secundários

Contacts

• Public contact
  • Full name: Mussara Gomes Cavalcanti Alves Monteiro
  • • Address: Cidade Universitária, s/n - Castelo Branco III
    • City: Joao Pessoa / Brazil
    • Zip code: 58051-085
  • Phone: +558332167417
  • Email: mussara.monteiro@hotmail.com
  • Affiliation: Universidade Federal da Paraíba
   
• Scientific contact
  • Full name: Mussara Gomes Cavalcanti Alves Monteiro
  • • Address: Cidade Universitária, s/n - Castelo Branco III
    • City: Joao Pessoa / Brazil
    • Zip code: 58051-085
  • Phone: +558332167417
  • Email: mussara.monteiro@hotmail.com
  • Affiliation: Universidade Federal da Paraíba
   
• Site contact
  • Full name: Mussara Gomes Cavalcanti Alves Monteiro
  • • Address: Cidade Universitária, s/n - Castelo Branco III
    • City: Joao Pessoa / Brazil
    • Zip code: 58051-085
  • Phone: +558332167417
  • Email: mussara.monteiro@hotmail.com
  • Affiliation: Universidade Federal da Paraíba
   

Additional links:

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