ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control

ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control (EDEN Study) - A Double-Blinded Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04127890

Acronym

EDEN

Enrollment

150

Registered

2019-10-16

Start date

2017-03-07

Completion date

2018-05-28

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

oxygen-enriched water

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.

Interventions

DIETARY_SUPPLEMENTELO Water

oxygen-enriched water

DIETARY_SUPPLEMENTPlacebo drinking water

bottled drinking water

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement of glycaemic control	12 weeks	Reduction in HbA1c and fasting plasma glucose
Weight loss	12 weeks	Reduction in weight

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026