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- Ensayo clínico NCT07791420
Measurement of Acute Metabolite Changes Following Consumption of Microalgae Drinks
28 de agosto de 2026 actualizado por: Jung Eun Kim, National University of Singapore
Measurement of Acute Metabolite Changes Following Consumption of Unprocessed and Processed Microalgae: A Randomized Crossover Trial
Protein consumption is essential for various physiological processes, with microalgae and plant proteins gaining increasing attention due to their health benefits.
To better understand how different protein types and processing methods impact health outcomes, this study aims to analyse the metabolite changes in response to different protein sources.
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
This study is a randomised crossover trial involving 16 participants.
It comprises one screening visit and five test visits, during which participants will consume intervention drinks containing primarily (1) maltodextrin, (2) whey protein isolate, (3) soy protein isolate, (4) bead-milled microalgae, or (5) non-bead-milled microalgae in a randomised order.
The study aims to investigate and compare acute postprandial metabolite responses following the consumption of bead-milled and non-bead-milled microalgae, as well as whey and soy protein isolates, in Singaporean adults.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Marven Ng, B.Sc.
- Número de teléfono: (+65) 8816 9977
- Correo electrónico: ngmarven@u.nus.edu
Ubicaciones de estudio
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Singapore, Singapur
- NUS, Department of Food Science and Technology, 1 Science Drive 3, Block S13, #03-07, Singapore, 117550
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Investigador principal:
- Jung Eun Kim, Ph.D., R.D.
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Contacto:
- Marven Ng, B.Sc.
- Número de teléfono: (+65) 8816 9977
- Correo electrónico: ngmarven@u.nus.edu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- English-literate and able to give informed consent
- Singaporean Chinese Adults aged 21 to 60 (inclusive)
- Body mass index of 18.5 to 23.0 kg/m^2 (inclusive)
- Healthy (Based on results from screening session)
Exclusion Criteria:
- Currently participating in another clinical study that involves altering the regular diet and/or involves consuming a dietary supplement or investigated food product as an intervention
- High blood pressure (≥ 140/90 mmHg)
- Underlying health conditions that may affect metabolic functions
- Consuming amino acid or protein supplements, or protein drinks, regularly (i.e., more than three times a week) for the past 3 months, and not willing to discontinue usage 3 months before and during the study duration
- Weight change > 3 kg in the past 3 months
- Weight < 50 kg
- Exercising vigorously over the past 3 months (i.e., engaging in high-intensity exercises for more than 3 hours a week, where high-intensity exercises leave one out of breath and unable to talk or sing during the workout)
- Current smokers or have quit smoking for less than 5 years
- Drinking > 2 alcoholic drinks per day (i.e., one drink is defined as either 150 ml of wine, 340 ml of beer/cider or 45 ml of distilled spirit)
- If drinking ≤ 2 alcoholic drinks per day, not willing to stop consumption of alcoholic beverages two days before and on the day of the test visits
- Not willing to stop consumption of caffeinated beverages 10 to 12 houFrs before and on the day of the test visits
- Currently on a specialised diet (e.g., Halal, vegetarian, vegan, weight loss diet)
- Had serious food allergies in the past, or having intolerance, sensitivities or allergies to any of the following: seaweed or algae and their derived products, milk/dairy products (e.g., whey), starch/starch-derived products (e.g., rice, corn, wheat, potato), soy/soy-derived products, gluten, eggs, nuts, peanuts, fish and crustaceans
- Disease or impairment of the kidney and/or liver*
- Currently diagnosed with diabetes*, gastrointestinal issues (e.g., lactose intolerance, irritable bowel syndrome), gout and/or G6PD deficiency
- Taking antibiotics 2 weeks prior to study participation
- Taking anti-hypertensive or cholesterol-lowering drugs for less than 3 years unless medically declared by an official doctor to be in stable condition
- Poor peripheral venous access based on past experiences with blood drawing
- Individuals with anemia and/or blood clotting disorders
- Donated blood within the 12 weeks prior to study participation
- Individuals with pacemaker or related electrical medical devices
- Pregnant, lactating, or planning pregnancy in the next 6 months
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Bead-milled microalgae
Consume a 400 mL drink containing 20 g protein equivalent of bead-milled microalgae
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Consume a 400 mL drink containing 20 g protein equivalent of bead-milled microalgae
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Comparador activo: Non-bead-milled microalgae
Consume a 400 mL drink containing 20 g protein equivalent of non-bead-milled microalgae
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Consume a 400 mL drink containing 20 g protein equivalent of non-bead-milled microalgae
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Comparador activo: Whey protein isolate
Consume a 400 mL drink containing 20 g protein equivalent of whey protein isolate
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Consume a 400 mL drink containing 20 g protein equivalent of whey protein isolate
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Comparador activo: Soy Protein Isolate
Consume a 400 mL drink containing 20 g protein equivalent of soy protein isolate
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Consume a 400 mL drink containing 20 g protein equivalent of soy protein isolate
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Comparador de placebos: Maltodextrin
Consume a 400 mL drink containing maltodextrin matched for the energy content of 20 g protein
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Consume a 400 mL drink containing maltodextrin matched for the energy content of 20 g protein
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in metabolites found in plasma (plasma metabolomics)
Periodo de tiempo: Baseline, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes
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Targeted metabolomics profiling of plasma will be conducted using liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS)
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Baseline, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes
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Changes in metabolites found in urine (urinary metabolomics)
Periodo de tiempo: Baseline and 300 minutes
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Targeted metabolomics profiling of urine will be conducted liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS)
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Baseline and 300 minutes
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Appetite
Periodo de tiempo: Baseline, 60, 120, 180, 240, 300 minutes
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The Appetite Visual Analogue Scale (VAS) questionnaire will be administered, with participants rating five appetite-related outcomes, i.e. desire to eat, hunger, fullness, satisfaction, and prospective food consumption.
Each response will be measured on a 100-mm visual analogue scale and scored from 0 to 100, with higher scores indicate a greater intensity of the outcomes being assessed, i.e. greater desire to eat, greater hunger, greater fullness, greater satisfaction, or a greater perceived amount of food that could be consumed.
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Baseline, 60, 120, 180, 240, 300 minutes
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jung Eun Kim, Ph.D., R.D., National University of Singapore, Department of Food Science and Technology
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
31 de agosto de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
19 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de agosto de 2026
Publicado por primera vez (Actual)
28 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- S38
- NUS-IRB-2026-444 (Otro identificador: National University of Singapore Institutional Review Board (NUS IRB))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Electronic copies of the data with identifiable participant information will be kept on NUS OneDrive with access limited only to A/P Kim Jung Eun and her research staff.
All data will be de-identified prior to statistical analyses.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .