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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02118
- Boston Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Control arm
Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added)
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실험적: Treatment arm
Medical food
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Medical food
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Total and extracellular water (by cold bromide and deuterium method)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
기간 |
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Hair loss (by photographic method and Hair-Scalp Questionnaire)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: Baseline, 12 weeks, and 24 weeks
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Baseline, 12 weeks, and 24 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Caroline Apovian, MD, Boston Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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