Efficacy and Safety of Deep Sea Water on the Blood Glucose Level

NCT ID: NCT03956914

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-02

Study Completion Date

2017-08-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was conducted to investigate the effects of daily supplementation of deep sea water on improvement of hyperglycemia

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was a 8 weeks, randomized, double-blind, placebo-controlled, cross-over clinical trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PreDiabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DSW (deep sea water) group

DSW, 440 ml/day for 8 weeks

Group Type EXPERIMENTAL

Deep sea water

Intervention Type OTHER

Deep sea water 440 ml/day for 8 weeks

Placebo group

Placebo, 440 ml/day for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placeob water 440 ml/day for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Placeob water 440 ml/day for 8 weeks

Intervention Type OTHER

Deep sea water

Deep sea water 440 ml/day for 8 weeks

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Fasting plasma glucose concentration of 100-140 mg/dL or 2h-postprandial plasma glucose concentration of 140 \~199 mg/dL

Exclusion Criteria

* Patients with type 1 or type 2 diabetes
* HbA1c ≥9.0%
* Weight decreased by more than 10% within past 3 months
* Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
* Hypoglycemic agent, obesity medicine, lipid lowering agent within past 6 months or functional food within past 2 month
* Subjects who have taken corticosteroid within past 1 months
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test by show the following results

* Serum AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \> 2 times the upper limit of normal range
* Serum Creatinine \> 2.0 mg/dl
* Pregnancy or breast feeding
* If a woman of childbearing doesn't accept the implementation of appropriate contraception
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kyungpook National University Hospital

OTHER

Sponsor Role collaborator

Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Soo-Wan Chae

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTCF2_2016_DSW

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Ginseng in Type 2 Diabetes
NCT02923453 COMPLETED PHASE2
Effect of Green Tea Extract on Type 2 Diabetes
NCT00567905 COMPLETED PHASE2/PHASE3