Whole Soy Replacement Diet on Metabolic Features
A Randomized Controlled Trial of Whole Soy Diet in Place of Red/Processed Meat and High Fat Dairy Products on Metabolic Features in Postmenopausal Women
Project title: A randomized controlled trial of whole soy diet in place of red/processed meat and high fat dairy products on metabolic features in postmenopausal women Objectives: Metabolic syndrome (MetS) is an escalating public health problem especially in postmenopausal women. Traditional whole soy foods are rich in unsaturated fats, high quality plant protein and various bioactive phytochemicals that could benefit on MetS. The aim of the study is to examine the effect of whole soy replacement diet on the features of MetS among postmenopausal women.
Hypothesis to be tested: Whole soy diet in place of red or processed meat and high fat dairy products will significantly improve metabolic features.
Design and subjects: This will be a 12-month randomized, single-blind, controlled trial among 208 postmenopausal women with high risk of MetS or early MetS.
Study instruments: After 4 weeks' run-in, participants will be randomly allocated to either of two intervention groups, whole soy replacement group or control group, each for 6 months.
Interventions: Subjects in whole soy group will be required to include 4 servings of whole soy foods (containing 25g soy protein) into their daily diet isocalorically replacing red or processed meat and high fat dairy products. Subjects in the control group will remain an usual diet.
Main outcome measures: The outcome measures will include the indices of metabolic features as well as a 10-year risk for ischemic cardiovascular disease.
Data analysis: The changes and %change of the metabolic features at 6- and 12-month will be compared among the two groups.
Expected results: Whole soy diet substitution of high saturated fat and cholesterol rich animal products will notably decrease the risk of MetS.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (予想される)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Zhao-min Liu, PhD
- 電話番号：2252-8790
- メール：liuzhaomin@cuhk.edu.hk
参加基準
適格基準
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:
- Postmenopausal women aged 45~70y within 15 years after menopause;
Participants who meet 2 or more of the following items:
- waist circumference WC ≥80 cm;
- triglyceride concentration ≥1.7 mmol/l;
- HDL-c <50 mg/dl (1.29 mmol/l);
- SBP/DBP ≥130/85 mm Hg;
- fasting glucose ≥5.6 mmol/l.
Exclusion Criteria:
- On use of medications known to affect body weight, lipids and glucose within past 3-month;
- Medical history or presence of severe systemic or endocrine diseases;
- Present or history of breast, endometrial or ovarian cancer;
- Abnormal uterine bleeding after menopause;
- On prescribed or vegetarian diet;
- Known soy allergy.
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Whole soy group
Whole soy replacement diet: to incorporate 4 servings of whole soy foods (equivalent to 25g soy protein) into their daily diet and reduce high saturated fat and cholesterol rich animal foods.
|
Participants who are allocated to Whole soy group will receive a 30~40 min counseling session by an experienced nutritionist on: 1) conventional lifestyle education on metabolic syndrome (MetS); 2) The benefits of whole soy diet; 2) Practical techniques to incorporate of 4 servings of whole soy foods (equivalent to 25g soy protein) into their daily diet and reduce high saturated fat and cholesterol rich animal foods based on their prior 7-day dietary record during run-in; (3) Participants will also receive a pamphlet and an 30 min DVD which will provide practical cooking recipes with both illustration and demonstration on how to prepare whole soy foods/diet in an easy and fun way to replace fatty animal meat and dairy products
|
|
プラセボコンパレーター：Control group
Usual diet: to receive a conventional lifestyle education on MetS.
|
Participants who are assigned to the usual diet group (control group) will receive a 5~10 min conventional lifestyle education on MetS by a research staff in which the general recommendation for macronutrient composition of the control diet will be 50-60% of energy as carbohydrate, 15-20% of energy as protein, and <30% of energy as total fat.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Changes of metabolic components of MetS (body weight, waist circumference, blood pressure, serum lipids and fasting glucose).
時間枠：Will be measured at baseline, 6-month and 12-month after intervention.
|
Will be measured at baseline, 6-month and 12-month after intervention.
|
二次結果の測定
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Changes of 10-year risk for ischemic cardiovascular disease (ICVD)
時間枠：Will be assessed at baseline and 12-month after intervention.
|
Will be assessed at baseline and 12-month after intervention.
|
協力者と研究者
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
研究開始
一次修了 (予想される)
一次修了
研究の完了 (予想される)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
最初の投稿
学習記録の更新
投稿された最後の更新 (見積もり)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- CRE-2013.121
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。