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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Louvain-La-Neuve, 벨기에, 1348
- UCLouvain - CICN
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Sequential intervention
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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)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Palmitoleic fatty acid pattern
기간: through study completion, an average of 4 months
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Area under the curve of palmitoleic fatty acid in serum calculated during 6 hours post-ingestion
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through study completion, an average of 4 months
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Docosahexaenoic fatty acid pattern
기간: through study completion, an average of 4 months
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Area under the curve of docosahexaenoic acid in serum calculated during 6 hours post-ingestion
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through study completion, an average of 4 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Omegaserum
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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