Bioavailability of Major Compounds of a Vegan Fatty-acid Nutraceutical and Its Effect on the Lipid Profile in Individuals With Suboptimal Serum-lipid Values
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Omega 3 index
研究概览
简要总结
In this randomized, controlled clinical study firstly the bioavailability of fatty acids and micronutrients of JP+® Omega Blend will be analysed. Secondly, the effect of the constituents contained in the nutraceuticals on blood lipid values will be determined. Thirdly, it will be examined, whether a dose-dependent effect of the supplementation of JP+® Omega Blend exists. Fourthly, the effect of a combined consumption of JP+® Omega Blend and Juice Plus+® Orchard, Garden and Vineyard blend (JP+® OGV) is investigated.
详细描述
In this randomized, controlled clinical study firstly the bioavailability of fatty acids and micronutrients of JP+Omega Blend will be analysed. Secondly, the effect of the constituents contained in the nutraceuticals on blood lipid values will be determined. Thirdly, it will be examined, whether a dose-dependent effect of the supplementation of JP+ Omega Blend exists. Fourthly, the effect of a combined consumption of JP+ Omega Blend and Juice Plus+® Orchard, Garden and Vineyard blend (JP+ OGV) is investigated.
RESEARCH QUESTIONS:
- To which extend will the ω-3-fatty acids, as well as certain micronutrients, such as carotenoids and tocopherols contained in the herbal fatty acid nutraceutical JP+® Omega Blend be resorbed?
- Are the ω-3 fatty acids bioavailable by increasing ω-3-index?
- Does a 4-month long supplementation with a plant-based herbal fatty acid nutraceutical (JP+ Omega Blend) exert a positive effect on lipid metabolism in subjects with suboptimal serum-lipid values?
- Does a dose-dependent effect on lipid profile exist in the subjects through supplementation of JP+ Omega Blend?
- Does the supply of JP+ Omega Blend combined with JP+® OGV exert different or additional effects on bioavailability and lipid metabolism in subjects with suboptimal serum-lipid values?
HYPOTHESES
- We hypothesise that the ω-3-fatty acids of JP+ Omega Blend will be absorbed in significant amounts in a dose-dependent manner and have a good bioavailability.
- We pursue the hypothesis, that the supplementation of JP+Omega Blend - at different dosage or combined with the consumption of JP+ OGV - will cause a positive effect on lipid metabolism in subjects with suboptimal serum-lipid values.
- Additionally, we hypothesise that carotenoids and tocopherols (="micronutrients") contained in Juice Plus+Omega Blend will be absorbed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •80 healthy men and women, 20-65 years
- •suboptimal serum lipid values without medication
- •triglycerides >140 mg/dl
- •HDL Chol < 45 (m) or < 50 mg/dl (w)
- •Non smokers
- •BMI >20 and <35 kg/m2
- •ω-3-fatty acid index (ω-3 index): rank 21 - 100 of the ranking or ω-3 index < 8%
- •normal nutrition (omnivore diet)
- •adherence to the 4-week long wash-out period
排除标准
- •all people not meeting the inclusion criterions
- •hypertension (systolic blood pressure > 160mmHg, diastolic blood pressure >100 mmHg)
- •Specific diets and nutritional habits (vegan, vegetarian, paleo, low-carb pregnancy)
- •aversion to stop the intake of nutritional supplements and food, that could interfere with the study outcome
- •over-consumption of fish (> 1 portion/week)
- •linseed and walnut oil, whole linseeds and walnuts (>1 portion (25g)/day)
- •with omega-3 fatty acids enriched "functional food
- •intake of lipid-lowering, anti-inflammatory, blood pressure lowering medication and anticoagulants
- •clinically relevant infectious disease
- •acute and chronic inflammatory disease
- •Diabetes mellitus type I and type II
- •supplementation of antioxidants in all variations, omega-3 fatty acids, plant extracts/concentrates
结局指标
主要结局
Omega 3 index
时间窗: 4 months
Omega 3 index in erythrocytes is a valid parameter to estimate bioavailability of omega 3 fatty acids
次要结局
- Change in lipid profile(4 months)
研究者
Lamprecht Manfred PhD, PhD
Sponsor Investigator
Green Beat