Very Low Calorie Diet Weight Loss
3 de febrero de 2022 actualizado por: Marielle PKJ Engelen, PhD, Texas A&M University
Omics Profiling of the Response to Food and Variability of Weight Loss in Medically Supervised Very Low Calorie Diet
Understanding how foods and nutrients are digested, absorbed and metabolized when weight is stable and during weight loss induced by very low calorie diet procedure using the technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics ("omics") will enable generation of new hypotheses that could explain the inter-individual differences in weight loss and could lead to optimization and individualization of therapies designed to lose weight.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The overarching hypothesis is that there are baseline, pre- and post-diet combinations of 'omics' signatures in response to food and nutrients that explain the weight loss response of obese subjects to the very low calorie (VLC) diet.
In order to address the general hypothesis the following specific aims will be addressed:
Specific Aim 1: To test the hypothesis that there is a combination of 'omics' parameters in response to a defined meal that discriminate between morbidly obese subjects.
Specific Aim 2: To test the hypothesis that variation in % weight loss to the 2-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.
Specific Aim 3: To test the hypothesis that variation in % weight loss to the 4-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.
Tipo de estudio
Intervencionista
Inscripción (Actual)
56
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
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Texas
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College Station, Texas, Estados Unidos, 77843
- Texas A&M University-CTRAL
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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
30 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion criteria obese subjects:
Diagnosed with morbid obesity (defined as BMI > 40 kg/m2 or BMI > 35 kg/m2 with at least one serious comorbidity (2013 NIH compendium guidelines)) Scheduled for medically supervised Very Low Calorie Diet Age 30 years and older Ability to lay in supine or elevated position for 5 hours Willingness and ability to comply with the protocol Exclusion Criteria Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only) Participation in Weight Loss Management Program within the last 6 months prior the first study day Presence of fever within the last 3 days Untreated metabolic diseases including hepatic or renal disorder unrelated to the primary disease Presence of acute illness or metabolically unstable chronic illness unrelated to the primary disease
· (Possible) pregnancy Any other condition according to the PI or nurse that would interfere with the study or safety of the patient Failure to give informed consent Use of protein or amino acid containing nutritional supplements within 3 days of first test day
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: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: obese
screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical and psychological information about them that will help determine study eligibility or can be used for later coding. 3 study days (one baseline, one approx 2 weeks of diet, one post-diet): muscle mass and function tests, resting energy expenditure, stable isotope infusions with blood draws, and questionnaires regarding quality of life, mood and depression, diet. |
como glicerol, D2O, tirosina, fenilalanina, glucosa, arginina y citrulina
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cambio en la síntesis neta de proteínas de todo el cuerpo
Periodo de tiempo: 0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 min
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Cambio en la tasa de síntesis de proteínas de todo el cuerpo después de la ingesta de comida
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0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 min
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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a fourteen item self-assessment scale.
Seven of the items related to anxiety and seven relate to depression.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression.
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Executive Function-Adolescent/Adult Sensory Profile (ASP)
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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a standardized self-questionnaire that generates an individualized profile of sensory processing across four quadrants: low registration, sensation seeking, sensory sensitivity, and sensation avoiding.
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Group differences in quality of life as measured by Short Form (36) Health Survey (SF36)
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT)
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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questionnaire is intended for use in an elderly population and focuses on 3 types of activities: leisure time activities, household activities and work-related activities.
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT)
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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a word page with words printed in black ink, a color page with blocks printed in color, and a color-word page where the color and the word do not match.
The examinee reads the words or names the ink colors as quickly as possible within a time limit.
Measures selective attention and inhibitory control.
The total time in seconds was reported for each trial.
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Group differences in state of mood as measured by the Profile of Mood State (POMS)
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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A psychological distress scale to measure mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.
Healthy populations take 3 to 7 minutes to complete, and others may take up a bit longer.
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Controlled Oral Word Association Test (COWAT): The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet.
The task contains three trials.
Measures phonetic verbal fluency.
The raw score (total and mean words recorded across the three trials) was reported.
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Auditory Verbal Learning Test (AVLT): a verbal episodic memory test that evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, retention and recognition of information
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Group differences in attention and executive functions as measured by PASAT
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Group differences in attention and executive functions as measured by Trail Making Test (TMT)
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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In Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy.
In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy.
Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility.
The total time in seconds was reported for each measure.
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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assesses several cognitive domains and is used for the screening of mild cognitive impairment.
Total scores range from 0-30 with lower scores indicating decreased functioning.
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Group differences in attention and executive functions as measured by Brief-A
Periodo de tiempo: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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a standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.
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Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
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Skeletal muscle strength
Periodo de tiempo: on study day 1 and the change from day 2 and day 3
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handgrip and kin-com 1-leg test
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on study day 1 and the change from day 2 and day 3
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24 hour diet recall
Periodo de tiempo: on study day 1 and the change from day 2 and day 3
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The subject is asked to recall in detail all the food and drink consumed during the 24 hours prior to the test day.
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on study day 1 and the change from day 2 and day 3
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Respiratory muscle strength
Periodo de tiempo: on study day 1 and the change from day 2 and day 3
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Maximum inhalation and exhalation pressure
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on study day 1 and the change from day 2 and day 3
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Body Composition
Periodo de tiempo: on study day 1 and the change from day 2 and day 3
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Body composition as measured by Dual-Energy X-ray Absorptiometry on study day 1 and the change from day 2 and day 3
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on study day 1 and the change from day 2 and day 3
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Gut function
Periodo de tiempo: postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on day 1 and the change from day 2 and day 3
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Digestion of the stable tracers of amino acid
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postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on day 1 and the change from day 2 and day 3
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Marielle Engelen, Texas A&M University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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)
1 de mayo de 2016
Finalización primaria (Actual)
1 de octubre de 2018
Finalización del estudio (Actual)
1 de octubre de 2018
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2016
Primero enviado que cumplió con los criterios de control de calidad
19 de mayo de 2016
Publicado por primera vez (Estimar)
23 de mayo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de febrero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
3 de febrero de 2022
Última verificación
1 de febrero de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB2016-0304
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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