Application of New Technologies and Tools to Nutrition Research (NutriTech)
13 de enero de 2020 actualizado por: Imperial College London
The overall objective of the research is to develop new methods for studying the link between diet, health and disease.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
The enquiry consists of two part. A metabolomic biomarker discovery study followed by a randomised controlled trial of moderate dietary induced weight loss.
A cohort of moderately overweight men and women will undergo a metabolomic study follow by randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week period. This intervention will improve the volunteer's body composition and reduce their risk of developing diabetes.
Extensive tests will be conducted before and after the dietary intervention using emerging technologies with current state-of-the-art methods. These tests will monitor the numerous physiological adaptations that have occurred on a gene, cell, organ and organismic level.
The study will, therefore, aim for a scientific breakthrough by developing a series of novel biological "markers" that can accurately determine an individual's health status.
Tipo de estudio
Intervencionista
Inscripción (Actual)
36
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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-
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London, Reino Unido, W12 0NN
- Imperial College London
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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
50 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy overweight volunteers (body mass index (BMI) of 25-30 kg/m2)
- Age between 50-65 years
Exclusion Criteria:
- Weight change of ≥ 3kg in the preceding 3 months
- Current smokers
- Substance abuse
- Excess alcohol intake
- Pregnancy
- Diabetes
- Cardiovascular disease
- Cancer
- Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- Kidney disease
- Liver disease
- Pancreatitis
- Have any metallic or magnetic implants such as pacemakers
- Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
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: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Life style advice
reduce energy intake by 20% less than estimated energy expenditure.
|
Metabolomic inquiry followed by a 12 week energy intake restriction.
This study is part of a very large European study called EPIC.
Only the results by Lee et al. 2016 have been presented here.
The results of the study published by Cheung 2017 are from a different study.
therefore the entries for the results are correct.
For this particular study, participants were not randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option.
In summary, both studies (lee and cheung) are considered as separate trials and results of the first phase where participants were assigned to one of five different diets, are reported separately.
Unfortunately no different NCT number is available.
Otros nombres:
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|
Comparador activo: UK background diet
Diet where energy intake will be matched with estimated energy expenditure.
|
Metabolomic inquiry followed by a 12 week energy intake restriction.
This study is part of a very large European study called EPIC.
Only the results by Lee et al. 2016 have been presented here.
The results of the study published by Cheung 2017 are from a different study.
therefore the entries for the results are correct.
For this particular study, participants were not randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option.
In summary, both studies (lee and cheung) are considered as separate trials and results of the first phase where participants were assigned to one of five different diets, are reported separately.
Unfortunately no different NCT number is available.
Otros nombres:
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Otro: Metabolomic inquiry
This inquiry took place prior to the randomized controlled trial and include 50 volunteers who will then be asked to volunteers of the weight loss study.
Were randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option.
|
Metabolomic inquiry followed by a 12 week energy intake restriction.
This study is part of a very large European study called EPIC.
Only the results by Lee et al. 2016 have been presented here.
The results of the study published by Cheung 2017 are from a different study.
therefore the entries for the results are correct.
For this particular study, participants were not randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option.
In summary, both studies (lee and cheung) are considered as separate trials and results of the first phase where participants were assigned to one of five different diets, are reported separately.
Unfortunately no different NCT number is available.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Insulin Sensitivity
Periodo de tiempo: Baseline, 12 weeks
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Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp.
Insulin Sensitivity assessment was only performed in the "Exercise" and "Exercise, Control" groups.
No data were collected for this Outcome from the remaining groups.
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Baseline, 12 weeks
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Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol
Periodo de tiempo: Baseline, 12 weeks
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Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment.
Statistical Analysis was performed only for the "Diet" Arm/Group.
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Baseline, 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body Composition
Periodo de tiempo: Baseline, 12 weeks
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Body Composition assessed by BMI
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Baseline, 12 weeks
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Changes in Adipocyte Morphology
Periodo de tiempo: 12 weeks
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Percentage Change in total adipose tissue assessed by MRI
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12 weeks
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Genome Integrity (DNA Methylation and Telomere Length)
Periodo de tiempo: 12 weeks
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12 weeks
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Body Weight
Periodo de tiempo: Baseline, 12 weeks
|
Baseline, 12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
Publicaciones Generales
- Lee S, Norheim F, Langleite TM, Noreng HJ, Storas TH, Afman LA, Frost G, Bell JD, Thomas EL, Kolnes KJ, Tangen DS, Stadheim HK, Gilfillan GD, Gulseth HL, Birkeland KI, Jensen J, Drevon CA, Holen T; NutriTech Consortium. Effect of energy restriction and physical exercise intervention on phenotypic flexibility as examined by transcriptomics analyses of mRNA from adipose tissue and whole body magnetic resonance imaging. Physiol Rep. 2016 Nov;4(21):e13019. doi: 10.14814/phy2.13019.
- Cheung W, Keski-Rahkonen P, Assi N, Ferrari P, Freisling H, Rinaldi S, Slimani N, Zamora-Ros R, Rundle M, Frost G, Gibbons H, Carr E, Brennan L, Cross AJ, Pala V, Panico S, Sacerdote C, Palli D, Tumino R, Kuhn T, Kaaks R, Boeing H, Floegel A, Mancini F, Boutron-Ruault MC, Baglietto L, Trichopoulou A, Naska A, Orfanos P, Scalbert A. A metabolomic study of biomarkers of meat and fish intake. Am J Clin Nutr. 2017 Mar;105(3):600-608. doi: 10.3945/ajcn.116.146639. Epub 2017 Jan 25.
- Yin X, Gibbons H, Rundle M, Frost G, McNulty BA, Nugent AP, Walton J, Flynn A, Gibney MJ, Brennan L. Estimation of Chicken Intake by Adults Using Metabolomics-Derived Markers. J Nutr. 2017 Oct 1;147(10):1850-1857. doi: 10.3945/jn.117.252197.
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
1 de abril de 2012
Finalización primaria (Actual)
1 de junio de 2015
Finalización del estudio (Actual)
1 de enero de 2016
Fechas de registro del estudio
Enviado por primera vez
11 de septiembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
11 de septiembre de 2012
Publicado por primera vez (Estimar)
13 de septiembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de enero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
13 de enero de 2020
Última verificación
1 de enero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12/L0/0139
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
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