- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03608254
Acute Effects of Watermelon on Vascular Function and Serum Lycopene
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Purpose and Objectives Arterial stiffness and endothelial dysfunction are early independent predictors of cardiovascular disease (CVD), the leading cause of death for women ages 60 and older in the United States. It is well-known that age-related decreases in vascular function are partially due to increases in oxidative stress and inflammation. In attempts to combat CVD, previous studies have investigated provision of isolated food compounds in supplement form. For example, purified lycopene has been shown to decrease oxidative stress, and our previous work supports the supplemental use of glutamine and arginine powders for improving vascular endothelial function of older adults. Watermelon is among the greatest plant sources of arginine and glutamine, and it is one of the richest sources of lycopene. However, clinical studies evaluating the whole food have not been done.
According to the Healthy Eating Index, only 27% of women ages 60 and older meet the daily dietary recommendations for 2.5 fruit servings. Likewise, although no Recommended Dietary Allowance for lycopene exists, this age group consumes less lycopene daily than is provided in one serving of watermelon. While reasons for poor fruit intake among older adults are multifactorial, difficulty chewing and inability to prepare fresh foods in the home environment have been noted as significant barriers to fresh fruit and vegetable intake. Of note, a previous systematic review suggests that 100% fruit and vegetable juices may be practical vehicles for improving intake of antioxidant nutrients among older adults. The provision of 100% watermelon juice to older adult women represents a practical, innovative approach to increase consumption of a food containing multiple components that may act in synergy to improve vascular function. Therefore, the purpose of this study is to investigate the effects of a one-time serving of 100% watermelon juice on blood vessel function and serum lycopene.
Specific Aims
The specific aims of this study are to:
To determine whether consumption of a 12-ounce serving of 100% watermelon juice by non-obese women ages 60-75 will result in increased levels of serum lycopene.
Hypotheses: Acute supplementation with 100% watermelon juice will result in increased serum lycopene.
- To determine whether consumption of a 12-ounce serving of 100% watermelon juice by non-obese women ages 60-75 will result in improved vascular endothelial function as assessed by flow-mediated dilation (FMD) and decreased arterial stiffness as assessed by pulse wave analysis (PWA).
Hypotheses: Acute supplementation with 100% watermelon juice will result in improved vascular endothelial function and decreased arterial stiffness.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Tuscaloosa, Alabama, Estados Unidos, 35487
- University of Alabama
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Body mass index 18.5 - 29.9 kg/m2 (non-obese)
- Ambulatory
- Postmenopausal female
- Ages 65-70 years
Exclusion Criteria:
- Food allergy to watermelon
- Diagnosis of phenylketonuria
- History of hypotension, chronic uncontrolled hypertension, chronic kidney disease, diabetes, previous cardiac events or procedures,
- Smoking or other tobacco use
- Use of anticoagulant medications, cholesterol-lowering medications, vasodilatory dietary supplements (garlic, fish oil), or dietary supplements containing lycopene, ascorbic acid, L-glutamine, L-arginine, or L-citrulline
- Weight change > 10% in the previous six months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Circulating Lycopene Levels
Periodo de tiempo: 2 hours post-ingestion
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On the testing day, participants reported to the clinic following a 10-hour overnight fast.
Blood samples were obtained by standard venipuncture at baseline and two hours after ingestion of a 360 ml dose of 100% pasteurized watermelon juice in order to determine change in serum lycopene levels.
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2 hours post-ingestion
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Endothelial-dependent Vasodilation
Periodo de tiempo: 2 hours post-ingestion
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Brachial artery flow-mediated dilation (FMD) was used to assess endothelial-dependent vasodilation.
FMD uses ultrasound technology to quantify changes in brachial artery diameter in response to hyperemia.
A blood pressure cuff was placed distal to the brachial artery of the right arm with the participant supine and rested.
Pre-inflation diameter was recorded for one minute, and the cuff was inflated to 50 mmHg above resting SBP for five minutes.
Then, images were recorded for 120 seconds after cuff deflation.
Peak diameter was determined as an average of the five highest measurements over five seconds post-deflation.
FMD was expressed as the percentage increase in peak diameter.
FMD measurements were taken at baseline and 2 hours after ingestion of the 100% watermelon juice.
The outcome measure reflects change in FMD from baseline to 2 hours post-ingestion.
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2 hours post-ingestion
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 15-07-95
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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