Mineralised drinking water to improve diabetes and high blood pressure control in Bangladesh
| ISRCTN | ISRCTN13257145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13257145 |
| Sponsor | Aquanimity Bangladesh Ltd |
| Funder | Centre for Global Health Research BADAS |
- Submission date
- 05/12/2025
- Registration date
- 22/12/2025
- Last edited
- 19/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Diabetes and high blood pressure are two major health problems in Bangladesh, and many adults struggle to keep these conditions under control despite using medicines. Some minerals, such as magnesium, zinc, chromium, potassium and selenium, may help improve blood sugar and blood pressure. Aeon HD® mineralised water contains a balanced combination of these minerals.
This study aims to find out whether drinking this mineralised water every day for 12 weeks can help improve blood sugar levels and blood pressure in adults with uncontrolled type 2 diabetes and hypertension, compared with drinking normal water.
Who can participate?
Adults aged 30–60 years who have type 2 diabetes that is not well controlled, high blood pressure that is not well controlled, and have been taking the same diabetes and blood-pressure medicines for at least 60 days. People who are pregnant, severely ill, planning to move away from Dhaka, or unable to participate safely will not be included.
What does the study involve?
Participants will be randomly assigned to one of two groups. The intervention group will drink Aeon HD® mineralised water (one 200 mL glass, three times per day). The control group will drink the same amount of normal filtered water. The study lasts 12 weeks. At the beginning and end of the study, participants will have blood tests (HbA1c, fasting glucose, cholesterol, kidney and liver tests) and measurements of blood pressure and body size (weight, BMI, waist and hip). Participants will also have one mid-study check at week 6 to review progress and any side effects.
What are the possible benefits and risks of participating?
Benefits: Participants may experience improvements in blood sugar or blood pressure. They will receive regular health check-ups and laboratory assessments at no cost.
Risks: Mild stomach discomfort could occur due to mineral content in the water, although such reactions are expected to be uncommon. Any side effects will be monitored by a study doctor who is available 24 hours for support.
Where is the study run from?
The study is being conducted at the Diabetic Association of Bangladesh (BADAS) Outpatient Diabetes Centre in Dhaka.
When is the study starting and how long is it expected to run for?
The study will begin in November 2025 and is expected to run for approximately 7 months, including preparation, participant recruitment, the 12-week intervention period, data analysis, and reporting.
Who is funding the study?
The study is funded by the Diabetic Association of Bangladesh (BADAS), with technical collaboration from the Centre for Global Health Research (CGHR) and Aquanimity Bangladesh Limited.
Who is the main contact?
Professor Dr Bishwajit Bhowmik
Principal Investigator
Centre for Global Health Research
Diabetic Association of Bangladesh
doctorbiplob@gmail.com
Contact information
Principal investigator, Scientific, Public
122 Kazi Nazrul Islam Avenue
Shahbag
1000
Bangladesh
 ORCID ID |
0000-0003-1114-5873 |
|---|---|
| Phone | +880 (0)1819287912 |
| doctorbiplob@yahoo.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Placebo | |
| Assignment | Single | |
| Purpose | Treatment | |
| Scientific title | Evaluation of Aeon HD® mineralised water for improving diabetes and hypertension control in Bangladesh | |
| Study acronym | AQUA-DHC | |
| Study objectives | Primary objective: To evaluate the efficacy of SuperWater® enriched with Aeon HD® in improving glycaemic control among patients with uncontrolled type 2 diabetes and hypertension. Secondary objectives: 1. To assess the effects of SuperWater® on blood pressure. 2. To assess the effects of SuperWater® on anthropometric measures (weight, body mass index, waist and hip circumference). 3. To evaluate changes in lipid profile, including total cholesterol, triglycerides, HDL-C, and LDL-C. 4. To examine changes in liver (SGPT) and renal function (serum creatinine). 5. To explore the safety and tolerability of daily consumption of SuperWater over 12 weeks. | |
| Ethics approval(s) |
Approved 10/11/2025, Ethics Review Committee of Diabetic Association of Bangladesh (BADAS) (122 Kazi Nazrul Islam Avenue, Shahbag, 1000, Bangladesh; +880 (0)1819287912; info@dab-bd.org; shakil480@gmail.com), ref: BADAS-ERC/EC 125162 | |
| Health condition(s) or problem(s) studied | 1. Aged 30–60 years 2. Diagnosed with uncontrolled or poorly controlled type 2 diabetes (HbA1c >8.0%, or fasting plasma glucose ≥10 mmol/L, or 2-hour post-breakfast glucose ≥12 mmol/L) 3. Diagnosed with uncontrolled hypertension (SBP >140 mmHg or DBP >90 mmHg) 4. On stable oral anti-diabetic and anti-hypertensive therapy for at least 60 days prior to enrolment 5. Willing and able to provide informed consent | |
| Intervention | Intervention group: SuperWater® enriched with Aeon HD® (zinc sulfate heptahydrate, chromium picolinate, magnesium sulfate, vanadium (IV) oxide sulfate hydrate, potassium sulfate, sodium selenate); 200 ml, three times daily for 12 weeks. Control group: Equivalent volume of normal filtered water. Adherence will be monitored through weekly contact and consumption logs. Participants will be randomly allocated in a 1:1 ratio to the intervention or control group using a computer-generated randomisation list created by an independent statistician who is not involved in participant recruitment or assessment. Randomisation will be performed using permuted block randomisation with variable block sizes of 4 and 6 to ensure balanced allocation throughout enrolment. The randomisation list will be stored in a password-protected file accessible only to the data manager. Sequentially numbered, sealed, opaque envelopes (SNOSE) will be used to conceal allocation at the time of enrolment. After baseline data collection, the research coordinator will open the next envelope in sequence to assign the participant to their group. Participants will remain blinded to group allocation; however, due to the nature of the intervention, investigators responsible for distribution of water cannot be blinded. Outcome assessors and laboratory staff will remain blinded to treatment assignment. | |
| Intervention type | Supplement | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
Measured at baseline and 3 months: | |
| Completion date | 05/06/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | Diabetes and hypertension |
| Key exclusion criteria | 1. Decline participation or fail to provide consent 2. Pregnant or lactating women, or planning pregnancy during the study 3. Acute renal failure, liver disease, or severe metabolic disorder 4. Insulin use for >1 week before enrolment 5. Major surgery, acute infection, or pancreatitis within the last 3 months 6. Mental health conditions limiting participation 7. Not residing in Dhaka during the study period 8. Normotensive or untreated hypertensive individuals |
| Date of first enrolment | 14/11/2025 |
| Date of final enrolment | 21/02/2026 |
Locations
Countries of recruitment
- Bangladesh
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | De-identified individual participant data (IPD) will be shared with qualified researchers upon reasonable request. Interested investigators may email the Principal Investigator with a short proposal and data-use plan. After approval, data will be shared through a secure, password-protected digital platform. All recipients must sign a Data Access Agreement confirming that data will be used only for the approved purpose, not re-identified, and not shared further. A data dictionary will be provided. |
Editorial Notes
08/12/2025: Study's existence confirmed by the Diabetic Association of Bangladesh (BADAS).
