Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery
Randomized, Pilot Study to Compare the Effects of a Novel Dietary Intervention With the Post-operative Standard of Care on Body Composition After Laparoscopic Gastric Bypass Surgery
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
STUDY SUMMARY The purpose of this pilot study is to compare a medical food intervention with the dietary standard of care at Boston Medical Center, in obese women subjects undergoing Roux-en Y gastric bypass surgery. Commercially available nutritional supplements will also be provided as part of the study's protocol.
Subjects will be selected from surgical candidates of the Nutrition and Weight Management Center who meet the study criteria. Subjects will be randomly assigned to one of the 2 groups (treatment and control). Subjects will be seen at the study site 2 weeks before surgery and 4 weeks, 8 weeks, 12 weeks, and 6 months after surgery (for a total of 5 visits). Data recorded during the study visits will be used to assess post-operative progress and will include: body composition, resting energy expenditure, muscle strength, quality of life questionnaires, hair loss, and blood markers for insulin resistance, nutritional state, organ function, lipid profile and inflammation. Safety indicators and compliance will also be monitored.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- Boston Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Obese and morbidly obese women (BMI 30 - 50)
- 25 years and older undergoing laparoscopic gastric bypass surgery
- Present with at least either metabolic syndrome or diabetes
Exclusion Criteria:
- Have smoked in the past 4 weeks
- Pregnant
- Allergic or intolerant to ingredients used in the study (e.g. soy and THIAA)
- There is a sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI) that makes the subject unsuitable for the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Control arm
Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added)
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Expérimental: Treatment arm
Medical food
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Medical food
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Total and extracellular water (by cold bromide and deuterium method)
Délai: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
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Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
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Dual energy X-ray absorptiometry (DEXA)
Délai: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
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Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Hair loss (by photographic method and Hair-Scalp Questionnaire)
Délai: Baseline, 12 weeks, and 24 weeks
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Baseline, 12 weeks, and 24 weeks
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Impedance plethysmography (by distal and proximal electrode placement)
Délai: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
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Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
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Muscle strength (by a handgrip dynamometer)
Délai: Baseline, 4weeks, 12 weeks, and 24 weeks
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Baseline, 4weeks, 12 weeks, and 24 weeks
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Resting energy expenditure (by indirect calorimetry)
Délai: Baseline, 4 weeks, 12 weeks and 24 weeks
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Baseline, 4 weeks, 12 weeks and 24 weeks
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Pulse after a 6-minute walk
Délai: Baseline, 4 weeks, 12 weeks, and 24 weeks
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Baseline, 4 weeks, 12 weeks, and 24 weeks
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Measures of insulin resistance, visceral protein/nutritional status, and inflammation
Délai: Baseline, 12 weeks, and 24 weeks
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Baseline, 12 weeks, and 24 weeks
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Caroline Apovian, MD, Boston Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BAR1-BMC-CT
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