ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Dietary Supplement: ELO Water; Dietary Supplement: Placebo drinking water

• Registration Number: NCT04127890
• Lead Sponsor: Changi General Hospital

Brief Summary

This double-blinded, randomised and controlled trial evaluates the efficacy of oxygen-enriched ELO drinking water as an adjuvant modality in diabetes care for enhancement of glycemic control in patients with Type 2 diabetes mellitus. Adults with type 2 diabetes will be randomized to drink 1.5 L of either ELO water or normal drinking water for 24 weeks. The primary outcome is improvement in glycaemic control.

Detailed Description

Global diabetes mellitus prevalence is rapidly increasing. In 2015, IDF reported that Singapore has 12.8% of its population diagnosed with diabetes mellitus, of which more than 90 percent are type 2 diabetes with underlying insulin resistance. With the aging population and increasing prevalence of obesity and sedentary lifestyles, the prevalence is expected to continue to rise.

In vitro studies demonstrated that hypoxia creates a state of insulin resistance through HIF (Hypoxia Inducible Factor) transcription factor expression in adipocytes. Insulin sensitivity was shown to improve in type 2 diabetes patients and overweight non diabetic patients placed in a hyperbaric oxygen chamber.Increased water intake has been associated with lower HbA1c in the general population , and also with lower post-prandial glucose in type 2 diabetic individuals.

This study aims to evaluate the effects of 1.5 L daily of ELO water, a drinking water enriched with molecular oxygen in a stable form, with a similar volume of bottled drinking water, on glycaemic control in adults with type 2 diabetes in Singapore.

Study Timeline

• Study Start: 2017-03-07
• Primary Completion: 2018-05-28
• Study Completion: 2018-05-28
• Study First Submitted: 2019-10-13
• Study First Submitted QC: 2019-10-13
• Study First Posted: 2019-10-16
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Type 2 diabetes mellitus with HbA1c 8.0% to 11%, within the last 6 months

Exclusion Criteria

1. Type 1 diabetes patients
2. Pregnant or lactating women
3. Comorbid conditions requiring fluid restriction to below 1.5 L daily
4. Terminal illness with life expectancy less than 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	ELO Water	1.5 L of ELO Water to be drunk daily for 24 weeks
Control Arm	Placebo drinking water	1.5 L of placebo bottled drinking water to be drunk daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Improvement of glycaemic control	12 weeks	Reduction in HbA1c and fasting plasma glucose
Weight loss	12 weeks	Reduction in weight

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore