ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control (EDEN)

Changi General Hospital

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Dietary Supplement: Placebo drinking water; Dietary Supplement: ELO Water

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04127890

ELOWater

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Intervention Arm

Experimental group

Description:

1.5 L of ELO Water to be drunk daily for 24 weeks

Treatment:

Dietary Supplement: ELO Water

Control Arm

Placebo Comparator group

Description:

1.5 L of placebo bottled drinking water to be drunk daily for 24 weeks

Treatment:

Dietary Supplement: Placebo drinking water