Randomized, Cross-over, Double Blinded, Placebo-controlled Study for the Evaluation of the Postprandial Effect of a Specific PHENOLic Compound on Blood PRESSure
试验速览
- 阶段
- 3 期
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change of Systolic Blood Pressure
研究概览
简要总结
The study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic BP after ingestion of a high fat meal.
详细描述
The study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic blood pressure (BP) after ingestion of a high fat meal.
The secondaries objectives are:
- To evaluate the effects on diastolic BP.
- To study the phenolic compound bioavailability and to analyze its metabolites for determine the phenolic compound consumption biomarkers.
- To evaluate the effects on endothelial function by ischemic reactive hyperemia (IRH).
The sample size was calculated using a previous studies using systolic blood pressure (SBP) as the primary outcome measure. A total of 14 subjects are needed, assuming variance components of approximately 20.0, to detect differences between treatments (placebo and phenolic product) of 10 mmHg, with a bilateral significance level of α=0.05, a power of 80% and a standard deviation of 11.82 mmHg at the baseline.
To compare the main variable efficiency of the products of study as well as secondary variables of efficiency, will carry out analysis of the covariance (ANCOVA) with basal value as covariable, followed by the Tukey test for determining multiple differences. All tests will be carried out with significance to bilateral level of 5%. It is considered significant value p<0,05. The data will be analyzed using the "SPSS" program version 22.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults men or women (>18 years old)
- •Blood pressure (with no drug intervention) ≥130 mm Hg systolic blood pressure ≤ 159 mmHg
- •No evidence of chronic disease
- •Written informed consent provided before the initial screening visit.
排除标准
- •Systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure ≥100 mm Hg or taking antihypertensive medication
- •Body mass index (BMI) ≥ 35 kg/m2
- •Glucose (fasting state) >125 mg/dL
- •LDL-cholesterol >189 mg/dL
- •Triglycerides >350 mg/dL
- •Pregnant or intending to become pregnant
- •Use of medication, antioxidant, or multi-vitamin supplements
- •Chronic alcoholism
- •Intense physical activity (5h/week)
- •Intestinal disorders
- •Following of a vegetarian diet
- •Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
- •Being intolerant or suffer from allergy to any of the products of the high fat meal (white bread, olive oil, boiled egg, cheese) or to the products of the study.
- •Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
- •Failure to follow the study guidelines.
研究组 & 干预措施
Phenolic compound
treated group
干预措施: phenolic compound (Dietary Supplement)
Placebo
control group
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Change of Systolic Blood Pressure
时间窗: In each visit (2 visits in total), systolic blood pressure will be measured at baseline (0 min) and 60, 120, 180, 240, 300 and 360 minutes after the ingestion of a fat load and the supplement.
During each visit (2 visits in total), systolic BP will be measured after 10 min in a seated position in a comfortable room by the physician. The measurement will be taken in triplicate at 1-min intervals using an automatic sphygmomanometer (OMRON HEM-907; PEROXFARMA, Barcelona, Spain). The first measurement will be discarded and the final result will be the average of the other measurements.. The research team will mesure the change in the evolution of systolic blood pressure between visits (at least 1 week between visits).
次要结局
- Diastolic Blood Pressure(In each visit (2 visits in total), diastolic blood pressure will be measured at baseline (0 min) and 60, 120, 180, 240, 300 and 360 minutes after the ingestion of a fat load and the supplement.)
- Ischemic reactive hyperemia (IRH)(In each visit (2 visits in total), at 0, 120, 240 and 360 minutes)
- Bioavailability of phenolic compound in plasma samples(In each visit (2 visits in total), at 0, 60, 120, 180, 240, 300 and 360 minutes (heparin lithium plasma))
- Bioavailability of phenolic compound in urine(In each visit (2 visits in total), at 0, 180 and 360 minutes (total urine))