To Evaluate the Effects of Omega 3 Fatty Acids in the Context of Cancer Prevention
Previous studies have demonstrated, in an in vitro micro-tumour model (the spheroid) and in a mouse model, that long-chain omega-3 fatty acids, in particular docosahexaenoic acid (DHA), can inhibit tumour development.
Therefore, the aim of this study was to collect DHA-enriched human serum, following ingestion of a DHA-enriched oil, in order to assess its effect on tumour development in vitro. Blood enriched in fatty acids not containing DHA will be used as a control condition, obtained after ingestion of olive oil.
This study is an important step to determine the interest of DHA supplementation as a new approach to prevent tumour development, and/or as an adjuvant to cancer treatments.
調査の概要
詳細な説明
The objective of this study is to collect DHA-enriched human serum in order to test it on the in vitro tumour model, spheroids. The results will be compared with human serum enriched in fatty acids (saturated, monounsaturated and polyunsaturated) but not in DHA.
To do this, the study will be divided into 4 steps
- determination of the time when a maximum concentration of fatty acids is observed in the serum after ingestion of olive oil (the control condition)
- blood sampling at baseline (fasting) and at Tmax after olive oil ingestion
- determination of the time when a maximum concentration of fatty acids is observed in the serum after ingestion of DHA-enriched oil (the test condition)
- blood sampling at baseline (fasting) and at Tmax after ingestion of DHA-enriched oil.
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
-
-
-
Louvain-La-Neuve、ベルギー、1348
- UCLouvain - CICN
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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:
- Woman or man, aged of 18 to 65 years;
- Body mass index between 20 and 30 kg/m2;
- For women: use of effective contraception;
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
- Uncontrolled systolic blood pressure > 160/100 mmHg;
- For premenopausal women: pregnant women or women planning to get pregnant within 3 months or lactating women;
- For menopausal women: less than 6 months of menopause;
- Type II diabetes (controlled or uncontrolled), Type I diabetes;
- Medical history or actual severe psychiatric, severe neurologic, severe hepatic, severe pancreatic, severe kidney, severe pulmonary, severe cardiovascular or severe gastrointestinal problem;
- Thyroid disorder;
- Cancer < 3 years before the inclusion;
- Consumption of drug under prescription or over-the-counter drug or dietary supplement (including n-3 PUFA) within 1 month before the inclusion (excepted contraception);
- Consumption of fish or of omega-3 enriched eggs > 2 times per week within 1 month before the inclusion;
- Subjects who are not able to understand and follow study procedures;
- Drug addiction problem (occasional or regular consumption);
- Women who drink more than 2 glasses of alcohol per day (> 20 g of alcohol per day or > 140 g/week) or men who drink more than 3 glasses of alcohol per day (> 30 g of alcohol per day or more than 210 g/week);
- Subjects having given their blood within less than 3 months before inclusion;
- Subjects having participated to another clinical trial with an investigational product within less than 1 month before the inclusion.
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：ヘルスサービス研究
- 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 |
|---|---|
|
他の：Sequential intervention
|
ingestion of olive oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h
ingestion of DHA oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h
ingestion of DHA oil (3g) and blood sampling at the fatty acids pic concentration (for in vitro study)
|
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 |
|---|---|---|
|
Palmitoleic fatty acid pattern
時間枠：through study completion, an average of 4 months
|
Area under the curve of palmitoleic fatty acid in serum calculated during 6 hours post-ingestion
|
through study completion, an average of 4 months
|
|
Docosahexaenoic fatty acid pattern
時間枠：through study completion, an average of 4 months
|
Area under the curve of docosahexaenoic acid in serum calculated during 6 hours post-ingestion
|
through study completion, an average of 4 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
- Omegaserum
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。