Dietary Protein Requirements in Hemodialysis Patients
Dietary Protein Intake and Its Effect on Nitrogen Balance in Maintenance Hemodialysis (MHD) Patients
調査の概要
詳細な説明
A high proportion of maintenance hemodialysis (MHD) patients have protein-energy malnutrition (PEM) which is a powerful predictor of high morbidity and mortality. Although inflammation may contribute to PEM, low dietary protein intake (DPI) is often a contributing factor. The usual DPI of MHD patients in about 1.0 g protein/kg/day, whereas expert groups recommend = 1.20 g protein/kg/day. However, these recommendations are based upon few studies, often of insufficient duration, that were usually carried out with obsolete types of dialysis therapy.
We will examine the response to different levels of dietary protein intake (0.6-1.3 g protein/kg/day) under classical balance techniques with carefully controlled dietary intakes, living, conditions, and collection of nitrogen outputs and carefully measured nitrogen intakes and outputs.
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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California
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Torrance、California、アメリカ、90509
- Harbor-UCLA 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:
- Ages from 30 years through 65 years
- Both men and women and all ethnic and racial groups
- Treatment with MHD for 6 months or greater
- Hemoglobin of at least 11 g/dL
- Neurological examination indicating no severe neuropathy
- A negative test for peripheral arterial occlusive disease
Exclusion Criteria:
- Obesity: body weight greater than >115% of standard
- History of active cancer other than basal cell carcinoma
- Symptomatic severe ischemic heart disease, uncontrolled serious dysrhythmias, uncontrolled congestive heart failure, poorly controlled hypertension, severe musculoskeletal disease, arthritis or amputations of the lower extremities
- Insulin dependent or insulin independent diabetes mellitus
- Severe lung or liver disease, uncontrolled asthma, active vasculitis. Severe chronic infection or any other acute or chronic inflammatory or catabolic illnesses
- Psychosis, inability to give informed consent, evidence that patient will not comply with study protocol
- Alcohol or other recreational drug abuse
- Patients who received L-carnitine or anabolic hormones within the previous 6 months
- Pregnancy
- Patients who are physically and/or psychologically incapable of undergoing the protocol
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：なし
- 介入モデル：単一グループの割り当て
- 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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実験的：Dietary Protein Intake
One treatment Arm; Protein Diet: All patients will be fed the following five diets, in random order, each for 17-19 days: 0.6 g protein/kg/day, 0.8 g protein/kg/day, 1.0 g protein/kg/day, 1.15 g protein/kg/day, 1.3 g protein/kg/day.
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Protein diets fed for 17-19 days to each patient in random order: 0.6 g protein/kg/day, 0.8 g protein/kg/day, 1.0 g protein/kg/day, 1.15 g protein/kg/day, 1.3 g protein/kg/day.
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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 |
|---|---|
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Nitrogen Balance
時間枠：One year
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One year
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協力者と研究者
捜査官
- 主任研究者：Joel D Kopple, MD、Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
出版物と役立つリンク
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。
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