Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects (POMEcardio)
Effect of an Ellagitannin Rich Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects. A Double-blind, Cross-over, Dose-response, Randomized, Placebo-controlled Trial (The POMEcardio Study)
The investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract.
The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory markers. The correlation between the effect exerted and the subjects' microbiota (capacity to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of urolithins on the effects.
調査の概要
状態
条件
介入・治療
- ダイエットサプリメント：Pomegranate extract-first dose-Group A
- ダイエットサプリメント：Pomegranate extract-first dose-Group B
- ダイエットサプリメント：Pomegranate extract-second dose-Group A
- ダイエットサプリメント：Pomegranate extract-second dose-Group B
- ダイエットサプリメント：Placebo-first dose-Group B
- ダイエットサプリメント：Placebo-first dose-Group A
- ダイエットサプリメント：Placebo-second dose-Group B
- ダイエットサプリメント：Placebo-second dose-Group A
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Murcia、スペイン、30107
- UCAM (San Antonio Catholic University from Murcia)
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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:
- Aged 40-65 years
- Body mass index (BMI) >27 kg/m2
- Healthy status (no illness in the previous 3-months).
Exclusion Criteria:
- Smoking.
- Pregnancy/lactation.
- Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
- Previous gastrointestinal surgery
- Recent use of antibiotics (within 1-month prior to the study)
- Suspected hypersensitivity to pomegranate or any of its components
- Consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication.
- Regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire).
- Intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.
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：処理
- 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：ダブル
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：Pomegranate extract
Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
他の名前：
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
他の名前：
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
他の名前：
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
他の名前：
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プラセボコンパレーター：Placebo
Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
Group B will consume 1 daily capsules of placebo for 3 weeks.
他の名前：
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
他の名前：
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
他の名前：
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in serum oxidized LDL-cholesterol concentration
時間枠：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effect on circulating levels of oxidized particles of LDL-cholesterol
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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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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Change in serum lipids and lipoproteins levels
時間枠：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effects on serum total cholesterol, LDL-cholesterol, HDL-cholesterol and apolipoproteins A1 (ApoA1), B (ApoB) and E (ApoE).
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in serum sICAM, sVCAM and hsCRP
時間枠：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effect on soluble intercellular adhesion molecule (sICAM), soluble vascular adhesion molecule (sVCAM) and high-sensitivity C-reactive protein (hsCRP)
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in fecal microbiota
時間枠：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Number of volunteers with adverse events as a measure of safety and tolerability
時間枠：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in phenolics and derived metabolites in plasma, feces and urine.
時間枠：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine.
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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協力者と研究者
協力者
捜査官
- 主任研究者：Dr. Juan Carlos Espín, PhD、National Research Council (CEBAS-CSIC, Murcia, Spain)
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
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