NCT04127890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

October 13, 2019

Last Update Submit

January 22, 2020

Conditions

Diabetes Mellitus

Keywords

oxygen-enriched water

Outcome Measures

Primary Outcomes (2)

  • Improvement of glycaemic control

    Reduction in HbA1c and fasting plasma glucose

    12 weeks

  • Weight loss

    Reduction in weight

    12 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Dietary Supplement: ELO Water

Control Arm

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo drinking water

Interventions

ELO WaterDIETARY_SUPPLEMENT

oxygen-enriched water

Intervention Arm
Placebo drinking waterDIETARY_SUPPLEMENT

bottled drinking water

Control Arm

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Joan Khoo, Dr

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2019

First Posted

October 16, 2019

Study Start

March 7, 2017

Primary Completion

May 28, 2018

Study Completion

May 28, 2018

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)