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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Louvain-La-Neuve、比利时、1348
- UCLouvain - CICN
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他: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)
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Palmitoleic fatty acid pattern
大体时间: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
大体时间: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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Omegaserum
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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