Red-fleshed Apple as a Novel Anthocyanin-biofortified Food to Improve Cardiometabolic Risk Factors: Innovation in Crop and Application to Health.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in serum LDL-cholesterol (measured in mg/dL)
研究概览
简要总结
The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix effect on the bioavailability of anthocyanins, and its effect on cardiometabolic risk factors, in two different products with a similar phenolic and anthocyanin content: the redlove apple and an aronia drink.
详细描述
The worldwide high prevalence of cardiovascular disease (CVD) requires lifestyle changes and new dietary prevention strategies based on the increased intake of foods rich in bioactive compounds, as they are considered as key mediators in the improvement of CVD risk factors.
Regarding the health impact on anthocyanins in cardiometalic risk factors and CVD, it has been reported that the dietary intake of anthocyanidins, among other classes of flavonoids, is inversely associated with the risk of CVD in both European and US population. A recent systematic review of human randomized controlled trials assessing the impact of anthocyanins on CVD markers concluded that one of the main modulated outcomes is the decrease of serum LDLc. However, diet does not appear to be sufficient to guarantee the necessary intake to obtain the health benefits specified. Due to previous positive results, a new dietetic strategy based on biofortification to enhance the levels of phenolic compounds is proposed in the present project.
The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix effect on the bioavailability of anthocyanins and its effect on cardiometabolic risk factors, in two different products with a similar phenolic and anthocyanin content: the redlove apple and an aronia drink.
Participants will be 120 free-living volunteers (men and women) with high LDL-cholesterol levels (LDL-cholesterol levels ≥115 mg/dl and ≥190 mg/dl) who will be assigned to one of the three arms for 6-week period of dietary treatment. The design of the intervention study is controlled, parallel and randomized. The intervention will combine acute (post-prandial) and chronic effects.
The sample size was computed to be sufficient to detect differences between treatment groups regarding the evolution in time of LDL-cholesterol levels. Justification of chosen sample size is based on assuming a 0.50mmol/l (approximately 15%) post-intervention difference of LDL-cholesterol and a 0.72mmol/l Standard deviation (SD), with α=0.05 and 1-β=0.08 a minimum of 22 participants were required. However the sample size will be 40 participants for arm, in total 120 subjects.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years old.
- •LDL-cholesterol levels ≥115 mg/dl and ≥190 mg/dl.
- •Sign the informed consent provided before the initial screening visit.
排除标准
- •LDL-cholesterol levels ≤115 mg/dl and <190 mg/dl.
- •Use of hypolipemiant treatment (drugs and functional foods), or hypoglucaemiant treatment.
- •Having diabetes mellitus type 1 or type
- •BMI values ≥35kg/m
- •Present triglycerides levels ≥350mg/dl.
- •Presenting anemia (hemoglobin ≤13g/dl in men and ≤12g/dl in women).
- •Subjects diagnosed of intestinal disorders such as Chron disease, colitis ulcerous, celiac disease and irritable bowel syndrome.
- •Present fructose and/or sorbitol and/or gluten intolerance.
- •Present clinical active chronic disease
- •Use of antioxidants supplements.
- •Being pregnant or intending to become pregnant.
- •Be in breastfeeding period.
- •Present chronic alcoholism.
- •Tobacco use.
- •Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- •Being unable to follow the study guidelines.
研究组 & 干预措施
Green Apple
Green Apple intervention
This product is a common cultivar apple without anthocyanins.
干预措施: Green Apple intervention (Other)
Redlove Apple
Redlove Apple intervention
This product is a biofortified cultivar apple with anthocyanins.
干预措施: Redlove Apple intervention (Other)
Aronia Drink
Aronia drink intervention
This product is an infusion of aronia fruit extract rich in anthocyanin.
干预措施: Aronia drink intervention (Other)
结局指标
主要结局
Changes in serum LDL-cholesterol (measured in mg/dL)
时间窗: 6 weeks, week 1 and week 6
Serum lipids will be measured by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland). Then, LDL-cholesterol will be alculated by the Friedewald formula.
次要结局
- Parameters of body composition (height measured in meters)(6 weeks, week 1)
- Changes in parameters of body composition (waist circumference measured in cm)(6 weeks, week 1, week 2, week 4 and week 6)
- Changes in ischemic reactive hyperemia (IRH measured in perfusion units)(6 weeks, week 1 and week 6)
- Changes in glucose markers (glucose and insulin measured in mg/dL)(6 weeks, week 1 and week 6)
- Changes in inflammation markers (c-reactive protein and serum endothelin-1 measured in mg/dL)(6 weeks, week 1 and week 6)
- Changes in dietary compliance markers (Phenolic compounds and metabolites measured in mg/L in 24h urine samples)(6 weeks, week 1 and week 6)
- Changes in fecal microbiota composition (relative abundance of the identified operational taxonomic units (OTUs) measured as % change from baseline)(6 weeks, week 1 and week 6)
- Changes in lipoprotein profile (number of LDL and HDL particles measured as % change from baseline)(6 weeks, week 1 and week 6)
- Changes in parameters of body composition (weight measured in kg)(6 weeks, week 1, week 2, week 4 and week 6)
- Changes in parameters of body composition (BMI measured in kg/m2)(6 weeks, week 1, week 2, week 4 and week 6)
- Changes in blood pressure (systolic blood pressure and diastolic blood pressure measured in mmHg)(6 weeks, week 1, week 2, week 4 and week 6)
- Changes in lipid plasmatic markers (total cholesterol, HDL cholesterol, triglycerides, non-esterified fatty acids, Apo B100 and Apo A. All these lipid plasmatic markers will be measured in mg/dL)(6 weeks, week 1 and week 6)
- Changes in oxidative markers (LDLox and Endogenous fat soluble antioxidants measured in mg/dL)(6 weeks, week 1 and week 6)
- Changes in faeces metabolites (Short Chain Fatty Acids, bile acids and sterols measured in mg/L in faeces samples)(6 weeks, week 1 and week 6)
- Changes in cholesterol efflux (measured as % change from baseline)(6 weeks, week 1 and week 6)
研究者
Rosa Sola
MD, PhD
University Rovira i Virgili