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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Boston Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Control arm
Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added)
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Eksperimentell: Treatment arm
Medical food
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Medical food
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Total and extracellular water (by cold bromide and deuterium method)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Hair loss (by photographic method and Hair-Scalp Questionnaire)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, 12 weeks, and 24 weeks
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Baseline, 12 weeks, and 24 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Caroline Apovian, MD, Boston Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BAR1-BMC-CT
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