Effects of Lignan-rich Diet on Cardiometabolic Risk Factors
关键词
抽象
描述
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.
日期
| 最后验证: | 11/30/2016 |
| 首次提交: | 06/15/2015 |
| 提交的预估入学人数: | 12/05/2016 |
| 首次发布: | 12/08/2016 |
| 上次提交的更新: | 12/05/2016 |
| 最近更新发布: | 12/08/2016 |
| 实际学习开始日期: | 05/31/2015 |
| 预计主要完成日期: | 09/30/2016 |
| 预计完成日期: | 09/30/2016 |
状况或疾病
干预/治疗
Other: Whole-grain rye, high lignan
Other: Whole-grain wheat, low lignan
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 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 | |
| Experimental: 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 |
资格标准
| 有资格学习的年龄 | 40 Years 至 40 Years |
| 有资格学习的性别 | Male |
| 接受健康志愿者 | 是 |
| 标准 | 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) |
结果
主要结果指标
1. Blood glucose levels [8 weeks]
次要成果指标
1. Blood lipids [8 weeks]
2. Inflammatory markers [8 weeks]
3. Oxidative stress markers [8 weeks]
4. Enterolignans in blood and urine [8 weeks]
