- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02042274
Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health (FOHS)
Omega-3 Fatty Acids and Genes Interact to Influence Cardiometabolic Health.
연구 개요
상세 설명
The typical Western diet is now recognized to have insufficient amounts of omega-3 fatty acids (in particular EPA and DHA). These fatty acids have several known health benefits, including improvements in heart health, metabolic syndrome, and inflammation. These benefits occur because omega-3 fatty acids can regulate a myriad of cellular functions. In order to increase the levels of these omega-3 fatty acids in the body, individuals must either consume more marine products or take an omega-3 rich dietary supplement, such as fish oil. While fish oil supplements are commonly consumed by people, it is now recognized that not everyone responds to these supplements in the same manner. Therefore this study aims to improve our understanding of why people respond differently to the same dietary supplement. The goals of this research will be accomplished using a number of approaches:
- The investigators will examine how fish oil supplementation leads to an enrichment of EPA and DHA in various cells throughout the body (erythrocytes, adipose tissue, etc).
- The investigators will determine the dynamic changes in EPA and DHA incorporation into different cell-types during distinct phases of our dietary intervention study (e.g. during supplementation and subsequent wash out periods).
- The investigators will study how fish oil supplements influence various blood markers of cardiometabolic health (e.g. triglycerides, cholesterol, glucose, C-reactive protein, etc) and whether this is modulated by an individual's genotype.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Guelph, Ontario, 캐나다, N1G2W1
- University of Guelph - Human Nutraceutical Research Unit
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- between 18-25 years old
- male
- good general health
Exclusion Criteria:
- currently taking a fish oil supplement
- currently taking an omega-3 supplement
- currently consuming a diet high in omega-3 (high in ALA, EPA, or DHA)
- not able to maintain a consistent lifestyle routine throughout the study duration
- have an allergy which would prevent them from taking a fish oil pill
- schedule conflict with study visits
- overweight or obese
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Fish oil supplement
Fish oil supplements providing up to 3g per day of EPA and DHA
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Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood Triglyceride
기간: Baseline, 3 months, 5 months
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Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
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Baseline, 3 months, 5 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood Glucose
기간: Baseline, 3 months, 5 months
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Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
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Baseline, 3 months, 5 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: David M Mutch, PhD, University of Guelph
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .