Blood pressure reduction in patients with high blood pressure (hypertension) with diet and lifestyle modificatio

Not Applicable

• Conditions: Hypertension; Circulatory System

• Registration Number: ISRCTN17705472
• Lead Sponsor: Twin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-25
• Last Update Posted: 9 May 2022
• Study Completion: 2025-01-14

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patients with a diagnosis of primary hypertension (either adequately controlled or inadequately controlled with blood pressure =180/110 mm Hg); both treatment-naive & on treatment (includes monotherapy or multiple drugs)
2. Aged 18 years and above
3. Willing to follow study specific activities and able to handle smartphone

Exclusion Criteria

1. Uncontrolled hypertension (>180/110 mm of Hg) or history of hypertensive emergency requiring admission
2. Hypertension due to secondary causes
3. History of Diabetes mellitus (when either of the following criteria is met: on medications to control blood sugar or FBS >126 mg/dl; RBS >200 mg/dl; HbA1c =6.5)
4. Symptomatic heart failure or EF <40%
5. Chronic kidney disease (eGFR less than 60 ml/min/1.73 m²) or history of any major renal anomalies like unilateral kidney, polycystic kidney
6. Any major cardiovascular event in the last 6 months (such as MI, stroke, TIA)
7. Hypertensive Retinopathy (grade 3 and above)
8. Weight loss more than 5% in 3 months
9. Arm circumference too large or small to allow accurate BP measurement with available devices
10. Special dietary requirements, or medications that would affect blood pressure (other than antihypertensive drugs) or nutrient metabolism
11. Unwilling or inability to modify current diet
12. Hypercalcemia (>10.5 mg/dl) and Hyperkalemia.(>5.5 mmol/l)
13. Known Malignant cases <5 years
14. Anemia (Hb <8 gm)
15. Major Gastrointestinal diseases such as Inflammatory bowel disease, irritable bowel syndrome that can interfere with dietary intervention
16. Use of contraindicated drugs such as antacids of magnesium, calcium, steroids, lithium, anti-migraine drugs, phenytoin, anti-psychotics (SSRI, SNRI, and TCA), immuno-modulators, any narcotic drugs, and oral contraceptives.
17. Having received any investigational drug or device within 30 days prior to entry into the study
18. Poor compliance during screening or run in.
19. Autoimmune disorders and Connective tissue disorders
20. Total bilirubin of >2 mg/dL or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 5 times the upper limit of normal range
21. Pregnant or planning to conceive in the next 3 years or breastfeeding
22. Psychiatric illness such as psychosis, manic depressive illness, alcohol or drug dependence.
23. Consumption of >14 alcoholic beverages per week (for women) and >21 for men
24. Any other condition or illness that the investigator feels would make the patient ineligible or make the patient difficult to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified