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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02118
- Boston Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Control arm
Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added)
|
|
|
Experimental: Treatment arm
Medical food
|
Medical food
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Total and extracellular water (by cold bromide and deuterium method)
Zeitfenster: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
|
Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
|
|
Dual energy X-ray absorptiometry (DEXA)
Zeitfenster: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
|
Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Hair loss (by photographic method and Hair-Scalp Questionnaire)
Zeitfenster: Baseline, 12 weeks, and 24 weeks
|
Baseline, 12 weeks, and 24 weeks
|
|
Impedance plethysmography (by distal and proximal electrode placement)
Zeitfenster: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
|
Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
|
|
Muscle strength (by a handgrip dynamometer)
Zeitfenster: Baseline, 4weeks, 12 weeks, and 24 weeks
|
Baseline, 4weeks, 12 weeks, and 24 weeks
|
|
Resting energy expenditure (by indirect calorimetry)
Zeitfenster: Baseline, 4 weeks, 12 weeks and 24 weeks
|
Baseline, 4 weeks, 12 weeks and 24 weeks
|
|
Pulse after a 6-minute walk
Zeitfenster: Baseline, 4 weeks, 12 weeks, and 24 weeks
|
Baseline, 4 weeks, 12 weeks, and 24 weeks
|
|
Measures of insulin resistance, visceral protein/nutritional status, and inflammation
Zeitfenster: Baseline, 12 weeks, and 24 weeks
|
Baseline, 12 weeks, and 24 weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Caroline Apovian, MD, Boston Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BAR1-BMC-CT
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .