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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02118
- Boston Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし:Control arm
Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added)
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実験的:Treatment arm
Medical food
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Medical food
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Total and extracellular water (by cold bromide and deuterium method)
時間枠: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)
時間枠: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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二次結果の測定
結果測定 |
時間枠 |
---|---|
Hair loss (by photographic method and Hair-Scalp Questionnaire)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠:Baseline, 12 weeks, and 24 weeks
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Baseline, 12 weeks, and 24 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Caroline Apovian, MD、Boston Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。