The Dose-response Effects of D-allulose (Psicose) With Sucrose Beverage on Glucose Tolerance and Insulin Level in Healthy Volunteers and Volunteers With Impaired Fasting Glucose
D-allulose
Hiperglucemia
+ Enfermedades metabólicas
+ Enfermedades Nutricionales y Metabólicas
Estudio de Prevención
Resumen
Fecha de inicio: 1 de abril de 2015
Fecha en la que se inscribió al primer participante.Objectives Primary objectives 1. To investigate the dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance 2. To investigate the dose-response effects of D-allulose (psicose) with sucrose beverage on insulin levels Subjects and methods Study product A. Sucrose 50 g B. Sucrose 50 g + D-allulose (psicose) 2.5 g C. Sucrose 50 g + D-allulose (psicose) 5 g D. Sucrose 50 g + D-allulose (psicose) 7.5 g E. Sucrose 50 g + D-allulose (psicose) 10 g Study plan Screening (visit 0) * Obtain inform consent * History taking for medical problems, smoking, alcoholic drinking, concurrent medication, contraception or menopausal status, weight history * Measure body weight, height and calculated BMI * Measure waist and hip circumference * Body composition measurement by bioelectrical impedance analysis (BIA) * Complete physical examination * Urine pregnancy test in all female of childbearing potential * Provide 24-hour food record * Ask to come back within 1 week Visit 1: (day 7 or 6-11 days) * Complete physical examination * Randomize subject to receive any 1 of 5 study products * Perform OSTT with that product * Return food record * Provide 24-hour food record * Adverse events evaluation * Ask to come back within 7 +/- 4 days Visit 2: (day 7 or 6-11 days from visit 1) * Complete physical examination * Randomize subject to receive any 1 of 4 study product which are left * Perform OSTT with that product * Return food record * Provide 24-hour food record * Adverse events evaluation * Ask to come back within 7 +/- 4 days Visit 3 (day 7 or 6-11 days from visit 2) * Complete physical examination * Randomize subject to receive any 1 of 3 study product which are left * Perform OSTT with that product * Return food record * Provide 24-hour food record * Adverse events evaluation * Ask to come back within 7 +/- 4 days Visit 4 (day 7 or 6-11 days from visit 3) * Complete physical examination * Randomize subject to receive any 1 of 2 study product which are left * Perform OSTT with that product * Return food record * Provide 24-hour food record * Adverse events evaluation * Ask to come back within 7 +/- 4 days Visit 5 (day 7 or 6-11 days from visit 4) * Complete physical examination * Perform OSTT with the product that is left * Return food record * Adverse events evaluation Adverse Event Assessment At each visit, participants will be asked an open question as if he/she has experienced any abnormal symptoms. Any symptom reported by the participants will be recorded as an adverse events with details of the event, its severity, start and stop dates, and relationship to study products. Gastrointestinal symptoms (heartburn, distension, nausea, vomiting, abdominal pain, flatulence, constipation and diarrhea) within 24 hours after OSTT will be asked and recorded as well. Withdrawal criteria 1. Those who are not able to complete 5 visits of OSTT within 8 weeks 2. Those who cannot provide 24-hour dietary record at each visit 3. Those who start any medication that might cause increasing in plasma glucose during participating in the study
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 30 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 85 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.5 grupos de intervención están designados en este estudio
20% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
Comparador ActivoGrupo III
Comparador ActivoGrupo IV
Comparador ActivoGrupo 5
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Clinical trial Unit, Faculty of Medicine, Chiang Mai University
Muang, ThailandAbrir Clinical trial Unit, Faculty of Medicine, Chiang Mai University en Google Maps