- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07563985
Effect of Lemon Juice and Apple Cider Vinegar on Postprandial Blood Glucose and Satiety in Healthy Individuals
The Effect of Lemon Juice and Apple Cider Vinegar on Postprandial Blood Glucose and Satiety in Healthy Individuals
This clinical study aims to examine how acidic drinks (lemon juice and apple cider vinegar) affect blood sugar when consumed with a starchy food. The study focuses on healthy individuals and aims to understand whether these drinks can slow the rise in blood sugar after meals and affect feelings of fullness.
The main questions this study aims to answer are:
Do lemon juice or apple cider vinegar lower the rise in blood sugar after a meal? Do these drinks increase feelings of fullness? Do different amounts change their effects?
Researchers will compare lemon juice and apple cider vinegar to see which one is more effective.
Participants will:
Consume white bread in the morning on an empty stomach with one of the following drinks:
Water only Water with lemon juice (50 g or 100 g) Water with apple cider vinegar (10 g or 20 g) Have a one-week break between each test. Have their blood sugar measured at regular intervals for 3 hours after eating. Report their level of fullness using a simple scale.
This study explores whether simple and practical dietary choices can help manage blood sugar levels. The findings may support new, easy-to-apply nutrition strategies for managing diabetes and weight.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Glycemic response plays an important role in the prevention and management of metabolic conditions such as diabetes and obesity. Different foods can cause rapid or slow increases in blood sugar levels. One factor that may influence this response is the acidity of foods. Acidic components may slow starch digestion and delay the rise in blood glucose by affecting digestive enzymes and gastric emptying. However, there are limited studies examining how the acidity of meals influences glycemic response in practical, real-life conditions.
This study is designed to investigate the effects of consuming acidic beverages, specifically lemon juice and apple cider vinegar, together with a starch-rich food. The study will compare their effects on post-meal blood glucose levels and feelings of fullness in healthy individuals. Different amounts of these acidic components will also be evaluated to understand dose-related effects.
Participants will consume standardized meals under controlled conditions, and their blood glucose response and satiety levels will be monitored over time. The study follows a comparative approach to assess the relative effectiveness of each intervention.
The findings of this study may help identify simple and practical dietary strategies to support better blood sugar control. As lemon juice and vinegar are widely available and easy to include in daily meals, the results may offer accessible approaches for improving dietary habits and supporting metabolic health.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ezgi Toptaş Bıyıklı, Assistant Professor
- Número de teléfono: 90 505 751 96 21
- Correo electrónico: ezgi.biyikli@alanya.edu.tr
Ubicaciones de estudio
-
-
Antalya
-
Alanya, Antalya, Turquía (Türkiye), 07400
- Reclutamiento
- Alanya Alaaddin Keykubat University
-
Contacto:
- Alanya Alaaddin Keykubat University
- Número de teléfono: +90 242 +90 242 510 60 60
- Correo electrónico: alku@alanya.edu.tr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Healthy male and female volunteers aged 18-35 years
- Body Mass Index (BMI) between 18.5 and 25.0 kg/m²
- Willingness to provide written informed consent
- Ability to comply with study procedures and fasting requirements
- No history of chronic metabolic, gastrointestinal, or endocrine diseases
Exclusion Criteria:
- Presence of any chronic disease (e.g., diabetes mellitus, cardiovascular disease, gastrointestinal disorders)
- Food allergies or intolerances to study foods (white bread, lemon juice, apple cider vinegar)
- BMI <18.5 or >25.0 kg/m²
- Regular participation in high-intensity physical activity (≥5 days/week)
- Current or recent (past 3 months) smoking or smoking cessation
- Use of any medication or supplements affecting glucose metabolism
- History of eating disorders
- Pregnancy, lactation, or menopause
- Female participants currently in menstruation period (testing will be postponed during menstruation days)
- Alcohol consumption within 24 hours prior to testing days
- Caffeine intake or major dietary changes on the day before testing
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Control (Water + White Bread)
Participants consume white bread together with plain water only.
This arm serves as the control condition to evaluate postprandial blood glucose response without any acidic additive.
|
Participants will consume 100 g of white bread together with plain water (no acidic additive).
This condition serves as the control arm for assessing baseline postprandial glycemic response and satiety.
Capillary blood glucose will be measured at baseline and at multiple time points up to 180 minutes following consumption.
Satiety and appetite sensations will be assessed using a 100-mm visual analog scale (VAS).
|
|
Experimental: Lemon Juice 50 g
Participants consume white bread together with water containing 50 g lemon juice.
This arm evaluates the effect of low-dose lemon juice on postprandial blood glucose response and satiety.
|
Participants will consume 100 g of white bread together with 50 g of lemon juice diluted in water.
This intervention is designed to evaluate the effect of a low-dose acidic beverage (citric acid source) on postprandial blood glucose response and satiety.
Capillary blood glucose levels will be measured at predefined time points up to 180 minutes, and subjective appetite sensations will be assessed using a 100-mm VAS.
|
|
Experimental: Lemon Juice 100 g
Participants consume white bread together with water containing 100 g lemon juice.
This arm evaluates the dose-dependent effect of lemon juice on postprandial blood glucose response and satiety.
|
Participants will consume 100 g of white bread together with 100 g of lemon juice diluted in water.
This condition evaluates the dose-dependent effect of citric acid intake on postprandial glycemic response, glucose peak, and satiety.
Serial capillary blood glucose measurements and VAS-based appetite assessments will be conducted over a 180-minute postprandial period.
|
|
Experimental: Apple Cider Vinegar 10 g
Participants consume white bread together with water containing 10 g apple cider vinegar.
This arm evaluates the effect of low-dose apple cider vinegar on postprandial blood glucose response and satiety.
|
Participants will consume 100 g of white bread together with 10 g of apple cider vinegar diluted in water.
This intervention aims to assess the effect of a low-dose acetic acid source on postprandial glucose regulation and satiety.
Capillary blood glucose will be measured at multiple time points for 180 minutes, and subjective appetite ratings will be recorded using a visual analog scale.
|
|
Experimental: Apple Cider Vinegar 20 g
Participants consume white bread together with water containing 20 g apple cider vinegar.
This arm evaluates the effect of higher-dose apple cider vinegar on postprandial blood glucose response and satiety.
|
Participants will consume 100 g of white bread together with 20 g of apple cider vinegar diluted in water.
This intervention evaluates the potential dose-response effect of acetic acid on postprandial glycemic control, including glucose peak, incremental glucose response, and satiety perception over a 180-minute period.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postprandial Blood Glucose (mg/dL)
Periodo de tiempo: Baseline (0 min) to 180 minutes postprandial on each test day (with 1-week washout between interventions)
|
Capillary blood glucose levels will be measured at baseline (0 min) and at 15, 30, 45, 60, 90, 120, 150, and 180 minutes after consumption of test meals.
Measurements will be performed in duplicate and mean values will be used.
|
Baseline (0 min) to 180 minutes postprandial on each test day (with 1-week washout between interventions)
|
|
Incremental Area Under the Curve (iAUC)
Periodo de tiempo: Baseline (0 min) to 180 minutes postprandial on each test day
|
Incremental area under the curve (iAUC) for postprandial blood glucose will be calculated based on capillary glucose measurements over 180 minutes.
|
Baseline (0 min) to 180 minutes postprandial on each test day
|
|
Total Area Under the Curve (AUC)
Periodo de tiempo: Baseline (0 min) to 180 minutes postprandial on each test day
|
Total area under the curve (AUC) for postprandial blood glucose will be calculated using capillary glucose measurements over 180 minutes.
|
Baseline (0 min) to 180 minutes postprandial on each test day
|
|
Peak Blood Glucose Level (mg/dL)
Periodo de tiempo: Baseline (0 min) to 180 minutes postprandial on each test day
|
Peak postprandial blood glucose level will be determined from capillary glucose measurements over the 180-minute period.
|
Baseline (0 min) to 180 minutes postprandial on each test day
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Subjective Appetite Score (VAS, mm)
Periodo de tiempo: Baseline (0 min) to 180 minutes postprandial on each test day
|
Subjective appetite sensations (hunger, satiety, fullness, prospective food consumption, and desire for sweet foods) will be assessed using a 100-mm Visual Analog Scale (VAS) at baseline and at 15, 30, 45, 60, 90, 120, 150, and 180 minutes postprandially.
|
Baseline (0 min) to 180 minutes postprandial on each test day
|
|
Time to Peak Glucose (minutes)
Periodo de tiempo: Baseline (0 min) to 180 minutes postprandial on each test day
|
Time to reach peak postprandial blood glucose will be calculated from capillary glucose measurements.
|
Baseline (0 min) to 180 minutes postprandial on each test day
|
|
Rate of Glucose Increase (mg/dL/min)
Periodo de tiempo: Baseline (0 min) to 180 minutes postprandial on each test day
|
Rate of increase in postprandial blood glucose will be calculated based on capillary glucose measurements.
|
Baseline (0 min) to 180 minutes postprandial on each test day
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Freitas D, Le Feunteun S. Inhibitory effect of black tea, lemon juice, and other beverages on salivary and pancreatic amylases: What impact on bread starch digestion? A dynamic in vitro study. Food Chem. 2019 Nov 1;297:124885. doi: 10.1016/j.foodchem.2019.05.159. Epub 2019 May 24.
- Ostman E, Granfeldt Y, Persson L, Bjorck I. Vinegar supplementation lowers glucose and insulin responses and increases satiety after a bread meal in healthy subjects. Eur J Clin Nutr. 2005 Sep;59(9):983-8. doi: 10.1038/sj.ejcn.1602197.
- Gheflati A, Bashiri R, Ghadiri-Anari A, Reza JZ, Kord MT, Nadjarzadeh A. The effect of apple vinegar consumption on glycemic indices, blood pressure, oxidative stress, and homocysteine in patients with type 2 diabetes and dyslipidemia: A randomized controlled clinical trial. Clin Nutr ESPEN. 2019 Oct;33:132-138. doi: 10.1016/j.clnesp.2019.06.006. Epub 2019 Jul 9.
- Freitas D, Boue F, Benallaoua M, Airinei G, Benamouzig R, Le Feunteun S. Lemon juice, but not tea, reduces the glycemic response to bread in healthy volunteers: a randomized crossover trial. Eur J Nutr. 2021 Feb;60(1):113-122. doi: 10.1007/s00394-020-02228-x. Epub 2020 Mar 23.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 10354421-2025/09-10
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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. .