Exercise and Nutrition on Obese Microbiome
3 de enero de 2020 actualizado por: Wesley Smith, University of Miami
The Effects of a Calorie-Restrictive Low-Carbohydrate Diet Versus an Unrestrictive Ancestral Diet on Microbiota and Cardiometabolic Disease Markers of Obese Individuals Performing an Intense Exercise Program
The purpose of this study is to examine the effects nine weeks of intense exercise training will have on weight, inflammation, and intestinal bacteria composition of overweight and obese adults.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
31
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.
Ubicaciones de estudio
-
-
Florida
-
Miami, Florida, Estados Unidos, 33146
- University of Miami
-
-
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
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion criteria:
- Individuals who are overweight (BMI ≥ 25) and/or obese (BMI ≥ 30).
- Individuals who volunteer for the 54-day exercise program.
- Individuals with no history of diabetes mellitus (type I or II) or sickle cell disease.
- Individuals who are not taking antibiotics and have not taken antibiotics within 3 months.
- Individuals who are not taking probiotics.
- Individuals who are not taking Metformin.
- Individuals who are cleared by their physician to perform strenuous exercise.
- Individuals with no physically debilitating injuries that would keep them from being able to perform the exercises prescribed.
- Individuals who are between 18 and 60.
Exclusion criteria:
1. Any subjects who do not meet all of the inclusion criteria and/or are unable to consent.
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Exercise Only Group (EX)
Participants will only receive the exercise protocol without nutrition education or counseling and instructed to continue to consume their regular diet.
|
The exercise protocol consists of a nine-week progressive intense-conditioning program involving six consecutive days (Monday-Saturday) of one-hour exercises and one-day rest weekly for a total of 54 days of exercise.
Exercises are performed in person as a group with other participating subjects and lead by certified instructors.
Exercises will involve a variety of activities ranging from running, cycling, whole-body functional movements, power movements, and open-chain weight lifting with barbells and resistance bands.
|
|
Experimental: Exercise with CR-LC Group
Participants will receive the exercise protocol and CR-LC Diet regimen.
|
The exercise protocol consists of a nine-week progressive intense-conditioning program involving six consecutive days (Monday-Saturday) of one-hour exercises and one-day rest weekly for a total of 54 days of exercise.
Exercises are performed in person as a group with other participating subjects and lead by certified instructors.
Exercises will involve a variety of activities ranging from running, cycling, whole-body functional movements, power movements, and open-chain weight lifting with barbells and resistance bands.
Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks.
CR-LC consists of caloric and macronutrient restrictions.
Caloric restrictions involves a 40% deficit from calculated total daily energy expenditure.
Macronutrient restriction involves a high protein, low carbohydrate diet (35% protein, 25% carbohydrate and 40% fat).
|
|
Experimental: Exercise with Ancestral Diet (AD) Group
Participants will receive the exercise protocol and AD regimen.
|
The exercise protocol consists of a nine-week progressive intense-conditioning program involving six consecutive days (Monday-Saturday) of one-hour exercises and one-day rest weekly for a total of 54 days of exercise.
Exercises are performed in person as a group with other participating subjects and lead by certified instructors.
Exercises will involve a variety of activities ranging from running, cycling, whole-body functional movements, power movements, and open-chain weight lifting with barbells and resistance bands.
Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks.
AD consists of consuming only whole foods and avoiding processed foods.
Emphasis will be on food quality with no caloric or macronutrient restrictions.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in fecal microbiota diversity
Periodo de tiempo: Baseline, 9 weeks
|
Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation
|
Baseline, 9 weeks
|
|
Change in Bacteriodetes/Firmicutes ratio
Periodo de tiempo: Baseline, 9 weeks
|
Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation
|
Baseline, 9 weeks
|
|
Percent change in fecal microbiota composition
Periodo de tiempo: Baseline, 9 weeks
|
Percent change in Bacteriodetes phyla and percent change of short-chain fatty acid-producing species as assessed via stool sample evaluation
|
Baseline, 9 weeks
|
|
Change in inflammatory markers
Periodo de tiempo: Baseline, 9 weeks
|
Change in serum inflammatory markers including Interleukin (IL)-1ß, IL-6, Tumor Necrosis Factor (TNF)-α and liposaccharide (LPS) evaluated in pg/ml.
|
Baseline, 9 weeks
|
|
Change in leptin/adiponectin ratio
Periodo de tiempo: Baseline, 9 weeks
|
Change in serum adipose markers assessed as change in leptin/adiponectin ratio.
|
Baseline, 9 weeks
|
|
Correlation of serum triglycerides with leptin levels
Periodo de tiempo: Baseline, 9 weeks
|
The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.
|
Baseline, 9 weeks
|
|
Change in body weight
Periodo de tiempo: Baseline, 9 weeks
|
Change in body composition as evaluated as change in body weight measured in lbs.
|
Baseline, 9 weeks
|
|
Change in resting metabolic rate
Periodo de tiempo: Baseline, 9 weeks
|
Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.
|
Baseline, 9 weeks
|
|
Change in body composition
Periodo de tiempo: Baseline, 9 weeks
|
Change in body composition as evaluated as change in body fat and lean body mass percentage
|
Baseline, 9 weeks
|
|
Change in waist circumference
Periodo de tiempo: Baseline, 9 weeks
|
Change in waist circumference measured in inches.
|
Baseline, 9 weeks
|
|
Change in blood pressure
Periodo de tiempo: Baseline, 9 weeks
|
Change in blood pressure assessed as systolic and diastolic pressure in mmHg.
|
Baseline, 9 weeks
|
|
Change in visceral fat
Periodo de tiempo: Baseline, 9 weeks
|
Change in visceral fat levels will be measured using InBody570 with scores ranging from 1-20, with the higher score indicating increased visceral fat (worse outcome).
|
Baseline, 9 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Wesley Smith, Ph.D., University of Miami
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 (Actual)
21 de octubre de 2019
Finalización primaria (Actual)
21 de diciembre de 2019
Finalización del estudio (Actual)
21 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
22 de octubre de 2019
Primero enviado que cumplió con los criterios de control de calidad
22 de octubre de 2019
Publicado por primera vez (Actual)
24 de octubre de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de enero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
3 de enero de 2020
Última verificación
1 de enero de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20190936
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .
Ensayos clínicos sobre Sobrepeso y Obesidad
-
Bambino Gesù Hospital and Research InstituteTerminadoObesidad Pediátrica Severa (IMC > 97° pc -Según Centers for Disease Control and Prevention IMC Charts-) | Pruebas de función hepática alterada | Intolerancia glucémicaItalia
Ensayos clínicos sobre Exercise Protocol
-
Boston University Charles River CampusNational Institute of Mental Health (NIMH)TerminadoTrastorno límite de la personalidadEstados Unidos