Effect of the Twin Precision diet intervention on hypertension
| ISRCTN | ISRCTN15834472 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15834472 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | TPT- 2/2020 |
| Sponsor | Twin Health |
| Funder | Twin Health |
- Submission date
- 16/01/2021
- Registration date
- 13/05/2021
- Last edited
- 13/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Elevated blood pressure arises from a combination of genetic and environmental risk factors. Some of the risk factors include high salt intake, low potassium intake, sedentary lifestyle, obesity, unhealthy diet and alcohol consumption. Also, patients with hypertension exhibit insulin resistance and hypertriglyceridemia compared to normotensive controls. Nutrition based therapy and lifestyle modifications serve as the first line of treatment for prevention as well as to control blood pressure in stage 1 hypertension. Dietary modifications have been widely considered an important step in the lifestyle modification strategy for prevention of hypertension.
The Twin Precision Treatment attempts to improve blood pressure control by measuring and treating the dysfunctional metabolism in the hypertensive patient. Using Digital Twin technology powered by artificial intelligence (AI) and Internet of Things (IoT) technologies, the Whole-Body Digital Twin Platform captures data on up to 174 health markers, up to 3000 daily data points to provide precision nutrition guidance to the patient that precisely balances 87 essential nutrient factors to optimize the metabolic functioning of the patient. Additionally, the Whole-Body Digital Twin platform also captures daily physical activity, sleep data and provides precision guidance on activity and sleep for the patient to follow.
Who can participate?
Participants on treatment for hypertension of either gender between 18 to 70 years can participate in this trial.
What does the study involve?
Participants will be randomised into either standard care arm (standard care medications for hypertension) or intervention arm (standard care plus twin precision treatment for diet modification) for 1 year. Follow up will continue for 2 years.
What are the possible benefits and risks of participating?
Participants in the intervention arm is expected to have normalization of blood pressure along with reduction in the number of anti-hypertensive medications. There is a rare chance for either lowering of blood pressure (hypotension) or increase in blood pressure (hypertension) Participants in the standard treatment arm will benefit by regular monitoring of blood pressure along with investigations for hypertension related complications.
Where is the study run from?
Bangalore Diabetes Centre (India)
When is the study starting and how long is it expected to run for?
November 2020 to December 2027
Who is funding the study?
Twin Health Pvt. Ltd. (India)
Who is the main contact?
Dr Paramesh Shamanna, paramesh@twinhealth.com
Contact information
Scientific
Bangalore Diabetes Centre
No. 426, 4th cross, 2nd block
Kalyan nagar
Bangalore
560043
India
 ORCID ID |
0000-0002-0693-4483 |
|---|---|
| Phone | +91 98450 10610 |
| paramesh@twinhealth.com |
Public
Bangalore Diabetes Centre
No. 426, 4th cross, 2nd block
Kalyan nagar
Bangalore
560043
India
| Phone | +91 98450 10610 |
|---|---|
| paramesh@twinhealth.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open label randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy and safety of Twin Precision treatment protocol on hypertension- an open label randomised controlled trial |
| Study objectives | Twin Precision based diet is effective in improving blood pressure and reducing requirement for anti-hypertensive medications |
| Ethics approval(s) | Approved 26/12/2020, Medisys Clinisearch Ethical review board (No. 426, 4th cross, 2nd block, Kalyan Nagar, Bangalore, 560043, Karnataka, India; +91 (0)80 25902546; bhargavicrc@gmail.com), ref: MCERB/2020/06 |
| Health condition(s) or problem(s) studied | High blood pressure |
| Intervention | Twin Precision treatment involves providing a personalising diet based on glycaemic excursions along with care of macro and micronutrients. The first phase will be a pilot study to check for the feasibility and plan the required sample size. 2 forms of diet intervention will be tried based on the net carbs utilised. One arm will receive Twin Precision diet with net carbs less than 50. The other arm in addition to Twin Precision diet net carbs 50 to 100 will be allowed The intervention will be for a period of 3 months Patients in the pilot study will be given an option to continue in the main study. The second phase will be the main trial with 2 groups. Group A will receive standard medications for hypertension. Group B will receive Twin Precision Nutrition along with the standard of care medications for hypertension. Intervention period: 1 year Follow up for additional 2 years (minimum of 1 year) |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Blood pressure as measured by ambulatory blood pressure monitoring at baseline and 3 months |
| Key secondary outcome measure(s) |
1. Blood pressure measured by ambulatory blood pressure monitoring and in the clinic (sphygmomanometer) at 6 months and 1 year |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 312 |
| Total final enrolment | 312 |
| Key inclusion criteria | 1. Patients between 18 to 70 years of age 2. On treatment for hypertension (monotherapy or multiple drugs) |
| Key exclusion criteria | 1. Uncontrolled hypertension (>180/110 mm/Hg) or history of hypertensive emergency requiring admission 2. Hypertension due to secondary causes 3. Diabetes mellitus 4. Heart failure with EF <45% 5. eGFR less than 60 ml/min/1.73 m² 6. Any major cardiovascular event in the last 12 months (such as MI, stroke, TIA) |
| Date of first enrolment | 15/04/2022 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- India
Study participating centre
Kalyan Nagar
Bangalore
560043
India
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Deidentified data will be archived for a period of 5 years from the time of completion of study and will be available upon request after publication of analysed results. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 31/12/2023.
2. The overall end date was changed from 31/12/2023 to 31/12/2027.
3. The intention to publish date was changed from 30/12/2023 to 30/12/2025.
4. The plain English summary was updated to reflect these changes.
5. The total final enrolment was added.
24/03/2022: The recruitment start date has been changed from 15/04/2021 to 15/04/2022.
30/03/2021: Trial's existence confirmed by Medisys Clinisearch Ethical review board
