RBR-5wmbzkw Headache attacks triggered by ingestion of watermelon: A source of citrulline that generates nitric oxide

Date of registration: 03/13/2022 ^(mm/dd/yyyy)
Last approval date : 03/13/2022 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1274-5981

• Public title:

  en

  Headache attacks triggered by ingestion of watermelon: A source of citrulline that generates nitric oxide

  pt-br

  Crises de dor de cabeça desencadeadas pela ingestão de melancia: Uma fonte de citrulina que gera óxido nítrico

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 41891320.8.0000.5214
    Issuing authority: Plataforma Brasil
  • 4.555.503
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal do Piauí

Sponsors

• Primary sponsor: Federal University of Piauí
• Secondary sponsor:
  • Institution: Federal University of Piauí
• Supporting source:
  • Institution: Federal University of Piauí

Health conditions

• Health conditions:

  en

  Migraine

  pt-br

  Enxaqueca

• General descriptors for health conditions:

  en

  R51 Headache

  pt-br

  R51 Cefaleia

• Specific descriptors:

  en

  G43.0 Migraine

  pt-br

  G43.0 Enxaqueca

Interventions

• Interventions:

  en

  A total of 76 participants with headache were divided into two equal groups: 38 with migraine and 38 with tension-type headache (control). Both groups were submitted to watermelon ingestion, in a standardized amount of 300 grams, in a liquefied form, with blood collection, pre- and post-ingestion, to determine the serum levels of nitrites and nitrates. All participants had to have fasted for at least eight hours and had been headache-free for at least 48 hours before ingesting the watermelon.

  pt-br

  Um total de 76 participantes com cefaleia foram divididos em dois grupos iguais: 38 com migrânea e 38 com cefaleia do tipo tensional (controle). Os dois grupos foram submetidos à ingestão de melancia, em uma quantidade padronizada em 300 gramas, de forma liquidificada, com coleta sanguínea, pré e pós-ingestão, para determinação dos níveis séricos de nitritos e nitratos. Todos os participantes deveriam estar em jejum de, no mínimo, oito horas, e sem cefaleia por, no mínimo, 48 horas antes da ingestão da melancia. Após a ingestão, os dois grupos foram orientados a informar o possível desencadeamento de cefaleia.

• Descriptors:

  en

  G07.203.300.456 Food supplementation

  pt-br

  G07.203.300.456 Suplementação alimentar

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 06/01/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  76	-	18 Y	50 Y

• Inclusion criteria:

  en

  Medicine student; Age between 18 and 50 years old; Brazilian nationality; Agree to undergo anamnesis, watermelon ingestion and blood collections; Diagnosis of migraine or other primary headache according to ICHD-3 criteria; and Be headache-free for at least 48 hours before ingesting the watermelon.

  pt-br

  Estudante de medicina; Idade entre 18 e 50 anos; Nacionalidade brasileira; Concordar em submeter-se à anamnese, ingestão de melancia e coleta de sangue; Diagnóstico de migrânea ou outra cefaleia primária de acordo com os critérios da ICHD-3; e Estar sem cefaleia por, pelo menos, 48 horas antes de ingerir a melancia.

• Exclusion criteria:

  en

  Headache frequency greater than or equal to 15 days per month; Women with headache only during the menstrual period; Association of migraine with other primary headache; In use of migraine prophylactics; Diagnosis of secondary headaches or unclassified headache; History of citrulline amino acid allergy; Consumption of watermelon or other sources of citrulline in the last 7 days; Intake of food supplement rich in citrulline; Associated diseases that would be compromised by ingestion of watermelon; Use of medications that compromise watermelon intake Diabetic patients; and Pregnant women.

  pt-br

  Frequência de cefaleia maior ou igual a 15 dias por mês; Mulheres com cefaleia apenas no período menstrual; Associação de migrânea com outra cefaleia primária; Em uso de profiláticos da migrânea; Diagnóstico de cefaleias secundárias ou cefaleia não classificada; História de alergia ao aminoácido citrulina; Consumo de melancia ou outras fontes de citrulina nos últimos 7 dias; Ingestão de suplemento alimentar rico em citrulina; Doenças associadas que seriam comprometidas com a ingestão de melancia; Uso de medicações que comprometam à ingestão de melancia Pacientes diabéticos; e Gestantes.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Diagnostic	Parallel	2	Single-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Expected outcome 1: Headache triggering was expected to be found only in patients with migraine, using watermelon ingestion in both groups.

  pt-br

  Desfecho esperado 1: Esperava-se encontrar desencadeamento de cefaleia apenas nos pacientes com migrânea, usando-se a ingestão de melancia nos dois grupos.

  en

  Outcome found 1: Headache triggering was observed in 23.7% of patients with migraine and in none of patients with tension-type headache.

  pt-br

  Desfecho encontrado 1: Foi observado desencadeamento de cefaleia em 23,7% dos pacientes com migrânea e em nenhum dos pacientes com cefaleia do tipo tensional.

• Secondary outcomes:

  en

  Outcome found 2: An increase in serum nitrite levels was observed after watermelon ingestion (23.37 mcg/mL versus 27.92 mgc/dL).

  pt-br

  Desfecho encontrado 2: Foi observado um aumento dos níveis séricos de nitrito após a ingestão de melancia (23,37mcg/ml versus 27,92mgc/dl).

  en

  Expected outcome 2: In patients with migraine, it was expected to find an increase in serum nitrite, using blood measurements and comparing the two blood samples.

  pt-br

  Desfecho esperado 2: Nos pacientes com migrânea, esperava-se encontrar um aumento de nitrito sérico, usando-se a dosagem sanguínea e comparando-se as duas coletas sanguíneas.

Contacts

• Public contact
  • Full name: Gabriela Leal Bezerra
  • • Address: Rua São Pedro, 2071/Centro - Ed. Raimundo Martins, Sala 304
    • City: Teresina / Brazil
    • Zip code: 64001260
  • Phone: +558632219000
  • Email: gabrielalealb05@gmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Natália Rebeca Alves Araújo
  • • Address: Campus Universitário Ministro Petrônio Portella/Ininga
    • City: Teresina / Brazil
    • Zip code: 64.049-550
  • Phone: +55 863237-2332
  • Email: nataliarebeca2607@gmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Suyanne Kássia Soares Pereira
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: suyanne.kassia2@hotmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Layana Karine Farias Lima
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: layana_farias@hotmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Luciano Silva Lopes
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: lucianofarmaco@ufpi.edu.br
  • Affiliation: Federal University of Piauí
  • Full name: Raimundo Pereira Silva-Néto
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: netoesperantina@terra.com.br
  • Affiliation: Federal University of Piauí
  • Full name: Sângela Fernandes Silva
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: san.med@outlook.com
  • Affiliation: Federal University of Piauí
   
• Scientific contact
  • Full name: Gabriela Leal Bezerra
  • • Address: Rua São Pedro, 2071/Centro - Ed. Raimundo Martins, Sala 304
    • City: Teresina / Brazil
    • Zip code: 64001260
  • Phone: +558632219000
  • Email: gabrielalealb05@gmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Natália Rebeca Alves Araújo
  • • Address: Campus Universitário Ministro Petrônio Portella/Ininga
    • City: Teresina / Brazil
    • Zip code: 64.049-550
  • Phone: +55 863237-2332
  • Email: nataliarebeca2607@gmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Raimundo Pereira Silva-Néto
  • • Address: Campus Universitário Petrônio Portella
    • City: Teresina / Brazil
    • Zip code: 64049550
  • Phone: 8632219000
  • Email: netoesperantina@terra.com.br
  • Affiliation: Federal University of Piauí
  • Full name: Suyanne Kássia Soares Pereira
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: suyanne.kassia2@hotmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Layana Karine Farias Lima
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: layana_farias@hotmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Luciano Silva Lopes
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: lucianofarmaco@ufpi.edu.br
  • Affiliation: Federal University of Piauí
  • Full name: Sângela Fernandes Silva
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: san.med@outlook.com
  • Affiliation: Federal University of Piauí
   
• Site contact
  • Full name: Natália Rebeca Alves Araújo
  • • Address: Campus Universitário Ministro Petrônio Portella/Ininga
    • City: Teresina / Brazil
    • Zip code: 64.049-550
  • Phone: +55 863237-2332
  • Email: nataliarebeca2607@gmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Raimundo Pereira Silva-Néto
  • • Address: Campus Universitário Petrônio Portella
    • City: Teresina / Brazil
    • Zip code: 64049550
  • Phone: 8632219000
  • Email: netoesperantina@terra.com.br
  • Affiliation: Federal University of Piauí
  • Full name: Gabriela Leal Bezerra
  • • Address: Rua São Pedro, 2071/Centro - Ed. Raimundo Martins, Sala 304
    • City: Teresina / Brazil
    • Zip code: 64001260
  • Phone: +558632219000
  • Email: gabrielalealb05@gmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Suyanne Kássia Soares Pereira
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: suyanne.kassia2@hotmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Layana Karine Farias Lima
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: layana_farias@hotmail.com
  • Affiliation: Federal University of Piauí
  • Full name: Luciano Silva Lopes
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: lucianofarmaco@ufpi.edu.br
  • Affiliation: Federal University of Piauí
  • Full name: Sângela Fernandes Silva
  • • Address: Rua São Pedro, 2071
    • City: Teresina / Brazil
    • Zip code: 64.001-260
  • Phone: 8632219000
  • Email: san.med@outlook.com
  • Affiliation: Federal University of Piauí
   

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