Milk Consumption and the Metabolic Syndrome in Menopausal Women (MILK)
Cardiovascular disease (CVD) represents the first cause of mortality in industrialized countries such as Canada and the United States. In that regard, it is being increasingly recognized that a significant proportion of CVD events may be attributable to the presence of a cluster of metabolic and physiological perturbations defined as the metabolic syndrome (MetS). The National Cholesterol Education Program- Adult Treatment Panel III (NCEP-ATP III) has recently proposed a clinical definition to identify individuals with the MetS. This definition is based on the presence of at least three of the following five characteristics: 1- abdominal obesity, 2- hypertriglyceridemia, 3- reduced plasma HDL-C levels, 4- high blood pressure, 5- high fasting blood glucose levels. Recent data have suggested that the MetS based on this definition was associated with a 2 to 5 fold increase in the risk of CVD in men as well as in women. These are alarming figures since it has been suggested that as much as 35 to 45% of female aged > 65 years in the US may have the MetS. It is therefore imperative to develop new preventive strategies that will be efficacious in attenuating the impact of the MetS on the progressing rates of CVD in women. In that context, there is accumulating evidence to suggest that milk and dairy products may beneficially modify several components of the MetS. However, most of the available data to date are based on observational studies or interventional studies with minimal nutritional control. Thus, metabolically controlled studies that document the impact of milk consumption on cardiovascular risk factors associated with the MetS in women defined a priori as having the MetS are utterly lacking.
The purpose of this study was to investigate the impact of milk consumption on features of the MetS in menopausal women presenting one or more features of the MetS.
調査の概要
詳細な説明
The proposed research will be undertaken as a randomized, cross-over, nutritionally controlled study, with participants being subjected to two 6-week isocaloric diets separated by a 4-week washout period. No stratification was considered since the population recruited will be relatively homogeneous. The experimental diet (designed as 'Milk') will be formulated so that the percentage of daily calories from fat (30%), saturated fat (10%), carbohydrates (55%) and proteins (15%) will conform to most of the dietary recommendations of the American Heart Association and the NCEP for primary prevention of CVD, with the exception of saturated fats (slight excess) and fibers (slight deficit). The cholesterol content of the experimental diet will not exceed 200 mg/day. The only source of dairy products during the experimental phase will be from 2% fat milk. We have chosen to use 2% fat milk because this is the most frequently consumed dairy product in Canada. Two percent fat milk also goes through minimal processing compared to milk or to other dairy products such as yogurt and cheese. Thus, bioactive components in milk are more likely to be retained in the 2% fat milk than in other more extensively processed products. The energy intake from milk will represent 20% of the consumed kcal/day. Based on a reasonable 2000 kcal/day regimen, a 20% intake attributable to 2% fat milk will correspond to 400 day/kcal, which will be derived from a 'daily dose' of 3 portions of milk/day. This dose has been shown to be effective in previous uncontrolled studies. The Control diet will be virtually identical in terms of menus, calories and macronutrient composition, with the exception that milk will be formally excluded from the regimen. The energy intake and changes in macronutrient composition attributable to the milk component in the experimental diet will be compensated in the control diet by modifying the protein, carbohydrate and lipid component of the various recipes.
A 4-week stabilization run-in period will precede the randomization of participants. During this run-in period, participants will be asked and instructed to comply to the NCEP-ATP III prudent diet. They will be asked to maintain their body weight constant during this period. Milk consumption will be adapted during this period to comply to the recommendations of NCEP-ATP III. The washout period between the two experimental diets will last 4 weeks and will also consist of NCEP-ATP III recommended diet. It must be stressed that foods will not be provided during the run-in and wash-out periods. These periods are imposed to minimize the inter- and intra-individual variability before and between the experimental phases.
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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Quebec、カナダ、G1V 0A6
- Institute of Nutraceutical and Functional Foods (INAF), Laval University
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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:
- Menopausal women (absence of menses > 12 months and FSH > 40 IU/ml), aged between 45 and 65 years
- Presenting 1 or more features of the MetS based on the NCEP-ATP III definition
- Average consumption of milk/dairy products fewer than 2 portions/d (≤ 1.9)
- Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
Exclusion Criteria:
- Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
- Subjects taking medications for hyperlipidemia, hypertension or hormonal replacement therapy
- Endocrine disorders
- Smoking
- Food allergies, milk aversion or intolerant to lactose
- Women with extreme nutritional habits such as vegetarism or alcohol consumption > 2 drinks/day
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:クロスオーバー割り当て
- マスキング:なし(オープンラベル)
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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Plasma TG levels (MetS criteria)
時間枠:At the beginning and the end of the two 6-week diets
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At the beginning and the end of the two 6-week diets
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HDL-C levels (MetS criteria)
時間枠:At the beginning and the end of the two 6-week diets
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At the beginning and the end of the two 6-week diets
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Systolic and diastolic blood pressure (MetS criteria)
時間枠:At the beginning and the end of the two 6-week diets
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At the beginning and the end of the two 6-week diets
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Fasting blood glucose (MetS criteria)
時間枠:At the beginning and the end of the two 6-week diets
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At the beginning and the end of the two 6-week diets
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二次結果の測定
結果測定 |
時間枠 |
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Anthropometric measures (waist and hip circumferences)
時間枠:At the beginning and the end of the two 6-week diets
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At the beginning and the end of the two 6-week diets
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LDL and HDL particle size
時間枠:At the beginning and the end of the two 6-week diets
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At the beginning and the end of the two 6-week diets
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Markers of the oxidative stress (i.e. oxLDL and 8-iso-PGF2a levels)
時間枠:At the beginning and the end of the two 6-week diets
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At the beginning and the end of the two 6-week diets
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Markers of a pro-inflammatory state (i.e. C-reactive protein and IL-6 levels)
時間枠:At the beginning and the end of the two 6-week diets
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At the beginning and the end of the two 6-week diets
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Surrogates of cholesterol absorption and synthesis
時間枠:At the beginning and the end of the two 6-week diets
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At the beginning and the end of the two 6-week diets
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Benoît Lamarche, PhD、Institute of Nutraceutical and Functional Foods (INAF), Laval University
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。
循環器疾患の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
MILKの臨床試験
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University of PittsburghNational Institute of Nursing Research (NINR)完了