Simbiótico de próxima generación en personas con sobrepeso u obesidad
Suplementación con un simbiótico de próxima generación en personas con sobrepeso u obesidad: un ensayo clínico controlado, aleatorizado, triple ciego
This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on gut and blood microbial composition. Synbiotic consumption is preceded by a 3-day antibiotic course to help ensure the opening of new niches (houses) for the upcoming beneficial bacteria.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a triple-blinded, randomized clinical trial in which participants will be allocated to one of two groups: 1) 3-day antibiotic followed by synbiotic consumption for 3 months or 2) 3-day antibiotic followed by placebo consumption for 3 months.
Blood and stool samples will be collected before the antibiotic, and before and after the symbiotic intervention in both groups.
Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA.
Glucose sensitivity will be measured through fasting glucose, fasting insulin, and HbA1c.
Body composition through DXA and BodPod will be measured before and after the symbiotic intervention.
Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories, as well as the RED-9 questionnaire to respectively measure anxiety, depression, and food cravings, will be applied before and after the symbiotic intervention.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Fort Worth, Texas, Estados Unidos, 76129
- Texas Christian University, Rickel Building
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- be between 18-50 years of age
- have a BMI between 25.0-40.0
Exclusion Criteria:
- are following a vegetarian, vegan, carnivore, or keto diet
- currently taking metformin, GLP-1 agonists, insulin, or fiber
- have taken antiacids, laxatives, probiotics, or medication that affects your immune system in the past month
- pregnant, planning pregnancy during the study period, or lactating
- have a history of inflammatory bowel disease, colon cancer, or chronic polyps
- have been diagnosed with type 1 or type 2 diabetes
- have active cancer
- are currently participating in a weight loss intervention (dietetic or medication)
- have used antibiotics, antifungals, or antivirals in the past 3 months
- have had a history of recent (within 30 days) diarrhea illness
- have a known allergy to any component of the study product
- have had an acute inflammatory infection or inflammatory condition in the past 4 weeks
- have had >10% weight variation in the past 6 months
- have had any bariatric surgery
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Synbiotic Group
They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month symbiotic. The synbiotic that will be used in this trial contains the oligosaccharide-degrading probiotics, Akkermansia muciniphila and Bifidobacterium infantis; butyrate producers such as Clostridium beijerinckii, Anaerobutyricum hallii, and Clostridium butyricum; and chicory-derived inulin, a prebiotic dietary fiber. |
WBF-038: Noninfectious and nonhazardous lyophilized commensal bacteria (probiotics). Contains no genetically modified organisms (GMOs) and contains no animal ingredients or by-products, and were originally isolated from human sources. The (probiotic) strains are grown in a FDA registered food facility, adhering to Good Manufacturing Practice (GMP) conditions. Probiotic Ingredients: Clostridium butyricum WBSTR-0006, Clostridium beijerinckii WB-STR-0005, Anaerobutyricum hallii WB-STR-0008, Akkermansia muciniphila WBSTR-0001, and Bifidobacterium infantis The product also contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)
Otros nombres:
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Comparador de placebos: Placebo Group
They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month placebo. |
Ingredients: Chicory inulin and oligofructose (prebiotic fiber, hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total Body Fat Mass through DXA (percentage)
Periodo de tiempo: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using DXA analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Total Body Fat Mass through BodPod (percentage)
Periodo de tiempo: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Mass to Height (kg/m2)
Periodo de tiempo: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using DXA analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Mass (kg)
Periodo de tiempo: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Body Lean Mass to Height (kg/m2)
Periodo de tiempo: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body lean mass by using DXA analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Free Mass (%)
Periodo de tiempo: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body lean mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Free Mass (Kg)
Periodo de tiempo: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body lean mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Visceral Fat Volume (cm3)
Periodo de tiempo: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body visceral mass by using DXA and BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Visceral Fat Mass (grams)
Periodo de tiempo: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body visceral mass by using DXA and BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fasting Glucose (mg/dL)
Periodo de tiempo: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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We will measure fasting glucose after a 12h fast. |
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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Fasting Insulin (mIU/L)
Periodo de tiempo: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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We will measure fasting insulin after a 12h fast. |
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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HbA1c (%)
Periodo de tiempo: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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We will measure HbA1c after a 12h fast. |
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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Anxiety (number in 0-63 scale)
Periodo de tiempo: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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We will measure anxiety by using the Beck Anxiety inventory. The higher the number, the higher the anxiety levels. |
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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Depression (number in 0-63 scale)
Periodo de tiempo: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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We will measure depression by using the Beck Depression inventory. The higher the number, the higher the depression. |
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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Food cravings (number in 0-52 scale)
Periodo de tiempo: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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We will measure food cravings by using the Reward-based Eating Drive questionnaire (RED-9). The higher the number, the higher the cravings. |
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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Gut Microbial Composition (depending on funding availability at the time of analysis)
Periodo de tiempo: Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
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We plan to measure gut microbial composition by performing whole metagenome sequencing previously stored in Zymo stool collection tubes. |
Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
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Blood Microbial Composition (depending on funding availability at the time of analysis)
Periodo de tiempo: Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
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We plan to measure blood microbial composition by performing 16S rRNA in blood samples previously stored in Zymo blood collection tubes. |
Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
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Body Weight (kg)
Periodo de tiempo: Measurements will take place at each of the 3 visits: right before the antibiotic, right before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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Body weight will be measured with a calibrated scale. |
Measurements will take place at each of the 3 visits: right before the antibiotic, right before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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Body Height (meters)
Periodo de tiempo: Measurement will take place at the first visit.
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Body height will be measured with a stadiometer. |
Measurement will take place at the first visit.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elisa Marroquin, Ph.D., Texas Christian University
Publicaciones y enlaces útiles
Publicaciones Generales
- Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1.
- Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319.
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2023-345
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified participant-level data can be shared only after authors and co-authors have published the material of their interest.
Marco de tiempo para compartir IPD
Data will be available only after authors and co-authors have published the material of their interest.
Criterios de acceso compartido de IPD
Not available at this point. Recruitment has not started.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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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