Immediate synergistic effect of beetroot and grapefruit juice on autonomic variables among hypertensive individuals - A comparative-randomized crossover study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Blood pressure, Heart rate variability
研究概览
简要总结
Beetroot juice is said to reduce blood pressure in hypertensives due to its nitrate content but redox nature of these compounds shortens its effect on blood pressure. Grapefruit juice a known CYP450 inhibitor which might inhibit reoxiation of nitrite in the beetroot. hence the study hypothesizes that grapefruit juice enhances the blood pressure lowering effects of beetroot juice in hypertensive individuals.
1. Grouping: 15 hypertensive subjects will be assessed three times with a washout period of three days by dividing into three groups with equal number
3 Groups
Group 1 (n = 5)
Group 2 (n = 5)
Group 3 (n = 5)
The institutional ethical clearance will be obtained prior to the conduct of the study. An informed consent will be obtained from the individuals by explaining the study objectives, methods, intervention and will be obtained from every participant after an appraisal about the study protocol. All the rights of the individual pertaining to the study in their own language.
After selecting the eligible subjects , Allotment will be done by using a Computer generated random number.
| Subject 1 Subject 2 Subject 3 | |||
| Day 1 Beetroot juice Beetroot juice + Grapefruit juice Grapefruit juice | |||
| Day 5 Grapefruit juice Beetroot juice Beetroot juice + Grapefruit juice | |||
| Day 9 Beetroot juice + Grapefruit juice Grapefruit juice Beetroot juice |
Note: Beetroot juice 70 ml in 250 ml water, grapefruit juice 250 ml , beetroot + grapefruit juice 70 ml + 250 ml
Assesments will be done before juice ingestion and 30 mins, 1.5 hrs, 3 hrs, 4.5 hrs post ingestion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.With primary arterial hypertension (greater than 140 mmHg systolic and/ or greater than 90 mmHg diastolic blood pressure) 2.Under antihypertensive medication from their primary care physician or specialist at the time of the investigation.
- •3.Those who were willing to participate in the study.
排除标准
- •1.Secondary hypertension 2.Two or more antihypertensive medications (resistant hypertension) 3.Severe psychiatric comorbidities 4.Coronary artery disease, myocardial infarction, pulmonary embolism, or stroke in the previous 3 months 5.Heart failure of NYHA stage 1 6.Renal failure of stage 2 or more (GFR less than 60mL/min/1.73m2) 7.Pregnancy or breastfeeding 8.Those who consumed beetroot or grapefruit in the last 4 days.
结局指标
主要结局
Blood pressure, Heart rate variability
时间窗: Baseline and 30 mins, 1.5 hrs, 3 hrs, 4.5 hrs post intervention
次要结局
- immediate blood pressure changes during each of the juice consumption(baseline, 30 mins and one hr post intervention)
研究者
Dr Abhay Sai
Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences, Ujire