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NCT04127890 Clinical Trial

ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control

Diabetes Mellitus Clinical Trial

— EDEN  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04127890
Other study ID # ELOWater
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 7, 2017
Est. completion date May 28, 2018

Study information
Verified date January 2020
Source Changi General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date May 28, 2018
Est. primary completion date May 28, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• ELO Water
oxygen-enriched water
• Placebo drinking water
bottled drinking water

Locations
Country Name City State
Singapore Changi General Hospital Singapore

Sponsors (2)
Lead Sponsor Collaborator
Changi General Hospital ELO Water Pte. Ltd.

Country where clinical trial is conducted

Singapore, 

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