Effects of Lignan-rich Diet on Cardiometabolic Risk Factors
연구 개요
상태
상세 설명
The study will be conducted in a randomized, cross-over design (8 wk intervention periods). The lignan-rich diet will be based on whole-grain rye products whereas the control diet will be based on whole-grain wheat products with some added wheat bran. Both diets will provide similar amount of whole grain (g/d) and total dietary fiber content (but dietary fibre quality will be different). Although rye has high lignan content, the aim is to further increase the lignan intake half-way through the whole grain rye intervention period. This will allow us to distinguish the effect of lignans from the effect of whole grain rye as well as evaluating potential differences in effects on cardiometabolic risk factors between whole grain wheat and whole grain rye intake after 4-week consumption. The study design will also allow us to investigate the effects of a putative interaction between microbiome x lignan rich diet and its implication of metabolic risk factors.
Blood samples will be collected by trained nurses at screening, baseline, after 4 weeks and 8 weeks of first intervention period, after wash-out (8 weeks), and after 4 weeks and 8 weeks of the second intervention period.
At each examination day participants will arrive to the test laboratory for blood samples and an oral glucose tolerance test (OGTT) where participants will be given a drink with 75 g of glucose to consume within 10 minutes. Blood samples will be taken after 30, 60 and 120 minutes. Furthermore, participants will be instructed to complete one 3-day weighted food record and also to collect 24-h urine and a fecal sample at week 0, 4, 8, 16, 20 and 24.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Uppsala, 스웨덴, SE-751 85
- Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- BMI > 25 kg/m2
- waist circumference > 102 cm
- at least one of the following: blood pressure >130/85 mmHg, serum triglycerides ≥1.69 mmol/L; HDL cholesterol <1.04 mmol/L; or serum glucose ≥6.1 mmol/L
Exclusion Criteria:
- smokers
- antibiotic use past 6 months
- cancer diagnose (past 5 years) or other chronic disease diagnosis
- excessive alcohol consumption (>21 units/week)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Whole-grain rye then wheat
Whole-grain rye, high lignan Whole-grain rye products for 8 weeks, then a wash-out period of 8 weeks, and then whole-grain wheat products for 8 weeks
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Intervention week 1-8: 50 g rolled rye + 50 g puffs + 4 pieces of crisp bread + 70 g pasta.
Additionally for intervention week 4-8: 4 lignan capsules per day
Intervention week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.
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실험적: Whole-grain wheat then rye
Whole-grain wheat, low lignan Whole-grain wheat products for 8 weeks, then a wash-out period of 8 weeks, and then whole-grain rye products for 8 weeks
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Intervention week 1-8: 50 g rolled rye + 50 g puffs + 4 pieces of crisp bread + 70 g pasta.
Additionally for intervention week 4-8: 4 lignan capsules per day
Intervention week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Blood glucose levels
기간: 8 weeks
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8 weeks
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2차 결과 측정
결과 측정 |
기간 |
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Blood lipids
기간: 8 weeks
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8 weeks
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Inflammatory markers
기간: 8 weeks
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8 weeks
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Oxidative stress markers
기간: 8 weeks
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8 weeks
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Enterolignans in blood and urine
기간: 8 weeks
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8 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Rikard Landberg, Swedish University of Agricultural Sciences
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 (추정)
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. .