The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota
The purpose of this dietary intervention is to study the effects of dietary fibers on the gut microbiota and use yoghurt as the carrier.
Hypothesis 1: Intake of dietary fibers improves the blood lipid profile of the participants.
Hypothesis 2: Intake of dietary fibers stabilizes the gut microbiome (e.g., low diversity) of the participants, improves gut health and normalizes gastrointestinal function and bowel habits.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study design is a parallel randomized, prospective, pre-post intervention trial. The main goal of this study is to investigate the effect of the dietary fibers in an unsweetened yoghurt. Fermented dairy products have naturally a very low dietary fiber content, but such products can be supplemented with variety of dietary fibers and promote the growth of beneficial gut bacteria. Also, as fermented milk products contain live bacteria, it is possible that prebiotic fibers could support the growth of the starter-culture based strains in the human gut.
PRE-STUDY EVALUATION AND TESTING
- Complete pre-study questionnaire
- Complete orientation to the study and provide voluntary consent to join the study
- Collection of coded intervention products, sampling supplies, and instructional materials 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT
1. Record food intake and gastrointestinal function for 3 days 2. Collect health data and provide a 3-day food frequency questionnaire 3. Provide a stool and blood sample at the laboratory 2-WEEK QUESTIONNAIRE AND LABORATORY VISIT
- Record food intake and gastrointestinal symptoms for 3 days
- Collect health data and provide a 3-day food frequency questionnaire
- Provide a stool and blood sample at the laboratory BLOOD SAMPLE ANALYSES
1. Provide the blood sample at the laboratory in the morning in an overnight fasted state.
DIETARY INTERVENTION
1. Daily intake of a test or control product for two weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Harjumaa
-
Tallinn, Harjumaa, Estonia, 12618
- Center of Food and Fermentation Technologies
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 25-55
- Normal bowel function
- Regular consumer of dairy products, willing to consume dairy products daily for 2 weeks
- Ability to provide a signed written informed consent
- Willing to provide stool and blood specimens 2 times over the 2-week study period
Exclusion Criteria:
- Diagnosed history of chronic diseases including coronary heart disease, stroke, cancer, type 1 or 2 diabetes mellitus, inflammatory bowel disease, gastritis, autoimmune disease, or rheumatoid arthritis
- Medication: statins, blood pressure medications, antidepressants, other prescription medications
- History of bariatric operation, removal of the gallbladder.
- Food allergies, lactose intolerance
- Recent (previous 3 months) use of antibiotics
- Intake of highly dosed pre- or probiotics 2 weeks prior and during the study
- Current pregnancy or breastfeeding
- Volunteers showing previously unrecognized illness will also be excluded
- Individual unable to give informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Test group
Healthy adults consuming test product
|
200 g/day of unsweetened yogurt supplemented with a dietary fiber blend
|
|
Comparador de placebos: Control group
Healthy adults consuming control product
|
200 g/day of unsweetened yogurt
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluation of the intestinal microbiota
Periodo de tiempo: 14 days
|
Fecal microbiota analysis based on the 16S rRNA sequencing pre- and post-dietary intervention.
|
14 days
|
|
Evaluation of blood lipid profile
Periodo de tiempo: 14 days
|
Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol pre- and post-dietary intervention in plasma (mmol/L).
|
14 days
|
|
Evaluation of blood glucose levels
Periodo de tiempo: 14 days
|
Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).
|
14 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluation of the stool form
Periodo de tiempo: 14 days
|
Stool form will be assessed using a validated 7-point scale called Bristol Stool Form Scale pre- and post-dietary intervention.
|
14 days
|
|
Evaluation of the defecation frequency
Periodo de tiempo: 14 days
|
|
14 days
|
|
Evaluation of the defecation timing
Periodo de tiempo: 14 days
|
Evacuation timing 3 days before sampling pre- and post-dietary intervention.
|
14 days
|
|
Evaluation of the gastrointestinal symptoms
Periodo de tiempo: 14 days
|
Frequency and severity of the gastrointestinal symptoms (Constipation, Diarrhea, Bloating, Flatulence, Cramps, Stomach pain).
Scale of frequency: Never, Less than 10 times a year, Once a month, Once a week, Every day.
Scale of severity: I do not have any gastrointestinal symptoms, Mild (does not disturb), Moderate, Strong (disturbs considerably).
|
14 days
|
|
Evaluation of the blood vitamin D status
Periodo de tiempo: 14 days
|
25-OH vitamin D pre- and post-dietary intervention in plasma.
|
14 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Madis Jaagura, MSc, TFTAK
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
Palabras clave
Otros números de identificación del estudio
- 2014-2020.4.02.19-0198
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Anonymized participant data could be made available for subsequent analysis in the mentioned institution (TFTAK).
Data made public will include only aggregates or summaries of the collected data.
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. .
Ensayos clínicos sobre Test product
-
Methodist Health SystemTerminado
-
University of MiamiUniversity of Tennessee Health Science CenterTerminadoObesidad | Actividad física | Función Cognitiva 1, SocialEstados Unidos
-
Suleyman Demirel UniversityTerminadoEstudiantes de EnfermeríaPavo
-
GRAIL, LLCCancer Research UK and King's College London Cancer Prevention Trials Unit...Activo, no reclutando
-
University of LeedsTerminadoHiperglucemiaReino Unido
-
Istinye UniversityInscripción por invitaciónCarrera | Tele-evaluación | La prueba Timed Up & Go | Prueba de soporte de silla de 30 segundosPavo
-
Imperial College LondonUniversity College London Hospitals; Northern Care Alliance NHS Foundation Trust y otros colaboradoresReclutamientoEsófago de Barrett | Cáncer de esófago | Esófago de Barrett con displasiaReino Unido
-
University Hospital, CaenINSERM U1075 COMETE, UNICAEN, Caen FranceTerminadoLesiones de tendones | Tensión muscularFrancia
-
Meir Medical CenterDesconocidoEstado Metabólico, Análisis de Respiración, NA-Nose
-
Assistance Publique - Hôpitaux de ParisAún no reclutandoNefritis intersticial aguda | Nefritis intersticial inducida por fármacosFrancia