Application of New Technologies and Tools to Nutrition Research (NutriTech)
13 janvier 2020 mis à jour par: Imperial College London
The overall objective of the research is to develop new methods for studying the link between diet, health and disease.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
36
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
London, Royaume-Uni, W12 0NN
- Imperial College London
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
50 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
|
Comparateur actif: 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.
Autres noms:
|
|
Autre: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Insulin Sensitivity
Délai: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
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Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol
Délai: Baseline, 12 weeks
|
Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment.
Statistical Analysis was performed only for the "Diet" Arm/Group.
|
Baseline, 12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Body Composition
Délai: Baseline, 12 weeks
|
Body Composition assessed by BMI
|
Baseline, 12 weeks
|
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Changes in Adipocyte Morphology
Délai: 12 weeks
|
Percentage Change in total adipose tissue assessed by MRI
|
12 weeks
|
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Genome Integrity (DNA Methylation and Telomere Length)
Délai: 12 weeks
|
12 weeks
|
|
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Body Weight
Délai: Baseline, 12 weeks
|
Baseline, 12 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2012
Achèvement primaire (Réel)
1 juin 2015
Achèvement de l'étude (Réel)
1 janvier 2016
Dates d'inscription aux études
Première soumission
11 septembre 2012
Première soumission répondant aux critères de contrôle qualité
11 septembre 2012
Première publication (Estimation)
13 septembre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12/L0/0139
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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