Metabolism Associated With Abdominal Fat Mass Distribution
Objectives:
The primary objective of this clinical trial is to characterize metabolic signatures associated with abdominal fat distribution in 40 women with different BMI 29-40 and different abdominal distribution of fat (visceral vs. sub-cutaneous fat).
No intervention with a product is planned. The subjects will be given one high fat meal with commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to test the post-prandial metabolic response.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Lausanne、スイス、1011
- University Hospitals, Service of endocrinology, diabetology, and metabolism
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Lausanne 26、スイス、1000
- Nestlé Clinical Development Unit / Metabolic Unit
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- BMI 29-40 kg/m2
- Aged 25-45
Exclusion Criteria:
- Diagnosed metabolic disorder such as Diabetes type 1 and 2, cardiovascular disease, metabolic syndrome
- Pregnancy
- Any pathology (infectious or other) having required an antibiotic therapy within 1 month prior to the beginning of the study.
- Any therapy (contraception apart) within the run-in period of one week before the test day.
- Subject who cannot be expected to comply with treatments and measures.
- Subject who is affected by any specific eating disorder
- Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- Subjects having recently undergone a weight loss of more than 3 kilos during the last 3 months
研究計画
研究はどのように設計されていますか？
コホートと介入
グループ/コホート |
|---|
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No product is tested
No intervention
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Metabolic plasma, urine and faeces profiles as a function of fat mass distribution
時間枠：Changes from baseline in metabolic profiles at one day following fat meal intake
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Metabolic profiles of plasma, urine and feces samples are obtained by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry. Fat mass distribution is assessed using CT scan and DXA (Dual X-Ray Energy Absorptiometry). |
Changes from baseline in metabolic profiles at one day following fat meal intake
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Insulin sensitivity
時間枠：Measured on the day before the fat meal intake
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Insulin sensitivity is measured by oral glucose tolerance test
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Measured on the day before the fat meal intake
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Basal Energy Expenditure
時間枠：Basal Energy Expenditure is measured on the day preceding the fat meal intake
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Basal Energy Expenditure is measured by indirect calorimetry
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Basal Energy Expenditure is measured on the day preceding the fat meal intake
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協力者と研究者
捜査官
- 主任研究者：Vittorio Giusti, MD, PD/MER、University Hospitals of Lausanne
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
本研究に関する用語
その他の研究ID番号
- 08.02.NRC
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。