Very Low Calorie Diet Weight Loss
3 février 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
56
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
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Texas
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College Station, Texas, États-Unis, 77843
- Texas A&M University-CTRAL
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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
30 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 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: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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. |
comme le glycérol, le D2O, la tyrosine, la phénylalanine, le glucose, l'arginine et la citrulline
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Modification de la synthèse nette des protéines du corps entier
Délai: 0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 minutes
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Changement du taux de synthèse des protéines du corps entier après la prise d'un repas
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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 minutes
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Marielle Engelen, Texas A&M University
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.
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 (Réel)
1 mai 2016
Achèvement primaire (Réel)
1 octobre 2018
Achèvement de l'étude (Réel)
1 octobre 2018
Dates d'inscription aux études
Première soumission
19 mai 2016
Première soumission répondant aux critères de contrôle qualité
19 mai 2016
Première publication (Estimation)
23 mai 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 février 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 février 2022
Dernière vérification
1 février 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB2016-0304
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Infusion d'acides aminés isotopes stables
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SMG-SNU Boramae Medical CenterInconnueDysfonction cognitive postopératoire
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Fred Hutchinson Cancer CenterMustang BioRecrutementLymphome à cellules du manteau récurrent | Lymphome récurrent de la zone marginale | Lymphome non hodgkinien réfractaire à cellules B | Petit lymphome lymphocytaire récurrent | Lymphome non hodgkinien récurrent à cellules B | Lymphome diffus à grandes cellules B récurrent | Lymphome diffus à... et d'autres conditionsÉtats-Unis
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Mehrdad Abedi, MDNational Cancer Institute (NCI)RecrutementLymphome diffus à grandes cellules B récurrent | Lymphome diffus à grandes cellules B réfractaireÉtats-Unis
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Joseph TuscanoNational Cancer Institute (NCI); ADC Therapeutics S.A.RecrutementLymphome à cellules B de haut grade avec réarrangements MYC et BCL2 ou BCL6 | Lymphome à cellules B de haut grade avec réarrangements MYC, BCL2 et BCL6 | Lymphome à double expresseur | Lymphome à cellules B de haut grade avec réarrangements MYC et BCL2 et/ou BCL6États-Unis