Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status
关键词
抽象
描述
Human intervention trials with anthocyanin-rich berry fruits/extracts such as whole strawberries, elderberry juice and whortleberry extracts, and purified anthocyanins from a mixture of blackcurrant and bilberry have been shown to beneficially alter biological markers for CVD risk, with beneficial effects on lipid profiles common across these studies.
In a randomized 3 phase crossover study we aim to recruit 50 participants (men and women) aged 45 years or more with a higher than optimal blood cholesterol level to consume capsules containing (i) 320 mg anthocyanins derived from bilberry fruit (delphinidin type), (ii) 320 mg anthocyanins derived from black rice (cyanidin type) and (iii) a placebo control. Each treatment will be ingested for 28 days with a wash-out period of 4 weeks in-between. Blood samples will be collected at the start and end of each 28-day treatment period to assess lipid status. In a subset of participants we will also investigate the relationship between bilberry and black rice anthocyanin ingestion on RNA expression profiles that are known to be involved in atherosclerosis, non-alcoholic fatty liver disease and reverse cholesterol transport as well as faecal excretion of bile acids and lipids.
日期
| 最后验证: | 11/30/2019 |
| 首次提交: | 07/04/2017 |
| 提交的预估入学人数: | 07/06/2017 |
| 首次发布: | 07/10/2017 |
| 上次提交的更新: | 12/08/2019 |
| 最近更新发布: | 12/09/2019 |
| 实际学习开始日期: | 09/24/2017 |
| 预计主要完成日期: | 09/29/2018 |
| 预计完成日期: | 09/29/2018 |
状况或疾病
干预/治疗
Dietary Supplement: Delphinidin type anthocyanins
Dietary Supplement: Cyanidin type anthocyanins
Dietary Supplement: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Delphinidin type anthocyanins Bilberry extract | Dietary Supplement: Delphinidin type anthocyanins Bilberry extract containing Delphinidin type anthocyanins |
| Active Comparator: Cyanidin type anthocyanins Black rice extract | Dietary Supplement: Cyanidin type anthocyanins Black rice extract containing Cyanidin type anthocyanins |
| Placebo Comparator: Placebo No anthocyanins | Dietary Supplement: Placebo No anthocyanins |
资格标准
| 有资格学习的年龄 | 45 Years 至 45 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Men and women ≥ 45 years of age - Total cholesterol ≥ 5.0 mmol/L Exclusion Criteria: - Smokers (or stopped smoking for less than 3 months) - Medical conditions that are judged to affect the primary outcome measure for this study or which may compromise the well-being of the participant e.g. diabetes. - Prescribed and non-prescribed medications that may affect the primary outcome measure for this study e.g. lipid lowering therapy - Dietary supplements judged to affect the study data unless the participant is willing to discontinue them for 4 weeks preceding the start of the study and for the duration of the study - Use foods for lowering cholesterol e.g. benecol, flora proactive - Regular/recent use of colonic irrigation or other bowel cleansing techniques. - Intend to change the normal use of pre or probiotics during the study (only applies to those collecting faecal samples) - Bowel movements ≤ 3 times per week (only applies to those collecting faecal samples) - Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated). - Parallel participation in another research project which involves dietary intervention - Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 ml. - Has donated or intends to donate blood within 16 weeks prior to or during the study period. - Any person related to or living with any member of the study team - Lack of capacity to provide written informed consent - Are pregnant or have been pregnant within the last 12 months |
结果
主要结果指标
1. LDL cholesterol [28 days]
次要成果指标
1. Total/HDL cholesterol and triglycerides [28 days]
2. Cholesterol efflux capacity [28 days]
3. PON-1 activity [28 days]
4. Bile acids and derivatives [28 days]
5. Glucose, fructosamine and insulin [28 days]
6. MicroRNA expression [28 days]
