A Randomized, Controlled, Double Blind Clinical Study to Evaluate Use of Hydron Alkaline Ionised Water (HAIW) in Healthy Participants
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Background and Objectives
Alkaline Ionized Water (AIW) is considered among the highest quality healthy drinking water worldwide and is widely discussed for its various health benefits. Hydron Alkaline Ionized Water (HAIW) is produced through electrolysis, resulting in a stable pH of approximately 9.5 with a negative Oxidation Reduction Potential (ORP), making it an antioxidant beverage. The objective of this study was to evaluate the safety of HAIW and its effects on digestion, sleep, energy, and overall quality of life in healthy participants compared to Packaged Drinking Water (PDW).
Materials and Methods
A randomized, controlled, double blind, prospective clinical study was conducted at Shivam Multi-specialty & Accident Care Centre Pvt. Ltd., Pune. A total of 24 healthy participants (21–40 years) were randomized in a 1:1 ratio to either HAIW Group (Group A, n=12) or Packaged Drinking Water Group (Group B, n=12), with equal gender distribution. Participants were hospitalized for 7 days and asked to consume at least 3 litres of the assigned water daily. Primary outcomes were safety-related laboratory parameters (CBC, LFT, RFT, Blood Sugar, ECG, Serum Electrolytes) and adverse event monitoring. Secondary outcomes included assessment of digestion (appetite, digestion, bowel habits), urine parameters, sleep quality, freshness after waking, fatigue (FSS), energy/stamina/strength, quality of life (WHO QOL BREF), and global assessment (CGI-I Scale).
Results
All 24 participants completed the study with no dropouts. Baseline demographics were comparable between the two groups. Assessment of primary safety-related laboratory parameters including CBC, liver function tests, renal function tests, blood sugar, ECG, and serum electrolytes showed non-significant change from baseline to 7 days and remained within normal limits in both groups, with non-significant difference between groups (p>0.05). HAIW showed significantly better improvement in appetite, digestion, and bowel habits from Day 2 onwards compared to PDW. Sleep quality and freshness after waking up showed significant improvement from Day 3 and Day 2 respectively in the HAIW and PDW group, with significantly better improvement in HAIW group. Fatigue scores showed significant reduction at Day 6 and 7 in both groups with non-significant difference between groups. A total of 5 adverse events were reported (3 in HAIW, 2 in PDW), all unrelated to study products and were mild in nature. Global assessment showed excellent to good overall safety and tolerability in both groups.
Conclusion
HAIW was well tolerated by all participants without any adverse effects. All laboratory safety parameters remained within normal range. HAIW demonstrated significant improvements in digestive function (appetite, digestion, bowel habits), sleep quality, and freshness after waking as compared to PDW. The study concludes that HAIW can be safely consumed. HAIW improves digestive and sleep-related functions.
