| CTRI Number |
CTRI/2024/05/067461 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Immediate effect of beetroot juice and grapefruit juice on blood pressure in hypertensive individuals |
|
Scientific Title of Study
|
Immediate synergistic effect of beetroot and grapefruit juice on autonomic variables among hypertensive individuals - A comparative-randomized crossover study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay Sai |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences, Ujire |
| Address |
Department of Diet and Nutrition( Naturopathy and Yoga), Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire
Belthangady
Dakshina Kannada
KARNATAKA
574240
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9482052965 |
| Fax |
|
| Email |
abhaysai2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Sai |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences, Ujire |
| Address |
Department of Diet and Nutrition( Naturopathy and Yoga), Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire
Belthangady
Dakshina Kannada
KARNATAKA
574240
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9482052965 |
| Fax |
|
| Email |
abhaysai2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth Shetty |
| Designation |
Principal |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady
Dakshina Kannada
KARNATAKA
574240
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9448252696 |
| Fax |
|
| Email |
drprashanth9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana |
|
|
Primary Sponsor
|
| Name |
Dr Abhay sai |
| Address |
Department of Diet and Nutrition( Naturopathy and Yoga), Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire, Belthangady, Dakshina kannada 574240 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhay Sai |
Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana |
Department of Diet and Nutrition (Naturopathy and Yoga),Shanthivana,
Dharmasthala
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9482052965
abhaysai2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Naturopathy and Yogic sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Beetroot juice |
Handpicked locally available fresh beetroots (Beta vulgaris L) will be selected for juice preparation. These will be later washed and rinsed thoroughly under cold tap water to remove dirt and debris. Once the peeling is done using a peeler, it will be chopped into cubicles. These cubicles will be used to extract beetroot juice. 70 mL of freshly prepared beetroot extract along with 250 mL of water will be given to subjects |
| Comparator Agent |
Grapefruit juice |
Locally available grapefruit (Citrus paradisi) will be selected, rinsed thoroughly, and cut into 2 slices. using a juicer, extract will be produced using these slices. 250 mL of this freshly prepared grapefruit extract will be given to subjects |
| Intervention |
Grapefruit juice mixed with Beetroot juice |
70 mL of freshly prepared beetroot extract will be mixed with 250 mL of freshly prepared grapefruit extract and given to subjects. ( extraction of these juices is same as comparator) |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood pressure, Heart rate variability |
Baseline and 30 mins, 1.5 hrs, 3 hrs, 4.5 hrs post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| immediate blood pressure changes during each of the juice consumption |
baseline, 30 mins and one hr post intervention |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 |