PreDiabetesNCT03956914
Efficacy and Safety of Deep Sea Water on the Blood Glucose Level
A study testing Deep sea water in people with PreDiabetes, run by Chonbuk National University Hospital.
Trial summary
This study was conducted to investigate the effects of daily supplementation of deep sea water on improvement of hyperglycemia Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Deep sea water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2016to 28 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting plasma glucose concentration of 100-140 mg/dL or 2h-postprandial plasma glucose concentration of 140 ~199 mg/dL
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: A 8-weeks, Randomized, Double-blind, Placebo-Controlled, Cross-Over Clinical Trials to Evaluated the Efficacy and Safety of Deep Sea Water on Blood Glucose Level
This study was conducted to investigate the effects of daily supplementation of deep sea water on improvement of hyperglycemia
Read the detailed description
This study was a 8 weeks, randomized, double-blind, placebo-controlled, cross-over clinical trial.
- Conditions
- PreDiabetes
- Being tested
- Placebo, Deep sea water
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placeob water 440 ml/day for 8 weeks
Deep sea waterOther
Deep sea water 440 ml/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| DSW (deep sea water) group | Experimental | DSW, 440 ml/day for 8 weeks Receives: Other: Deep sea water |
| Placebo group | Placebo comparator | Placebo, 440 ml/day for 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of blood glucose
Concentration of fasting and postprandial glucose during OGTT (oral glucose tolerance test) were assessed before and after the intervention
Measured: Baseline, 8 weeks
Secondary outcomes (14)
Changes of blood insulin
Concentration of blood insulin were assessed before and after the intervention
Measured: Baseline, 8 weeks
C-pepetide
Concentration of C-peptide were assessed before and after the intervention
Measured: Baseline, 8 weeks
HbA1c
Concentration of HbA1c were assessed before and after the intervention
Measured: Baseline, 8 weeks
Homeostatic model assessment - insulin resistance (HOMA-IR)
Concentration of HOMA-IR were assessed before and after the intervention
Measured: Baseline, 8 weeks
Total cholesterol
Concentration of total cholesterol were assessed before and after the intervention
Measured: Baseline, 8 weeks
Triglyceride
Concentration of triglyceride were assessed before and after the intervention
Measured: Baseline, 8 weeks
HDL-cholesterol
Concentration of HDL-cholesterol were assessed befor and after the intervention
Measured: Baseline, 8 weeks
LDL-cholesterol
Concentration of LDL-cholesterol were assessed befor and after the intervention
Measured: Baseline, 8 weeks
Weight
Concentration of weight were assessed befor and after the intervention
Measured: Baseline, 8 weeks
BMI
Concentration of BMI were assessed before and after the invervention
Measured: Baseline, 8 weeks
Body fat mass
Concentration of body fat mass were assessed before and after the intervention
Measured: Baseline, 8 weeks
Percent of body fat mass
Concentration of percent of body fass mass were assessed before and after the intervention
Measured: Baseline, 8 weeks
Waist circumference
Concentration of waist circumference were assessed before and after the intervention
Measured: Baseline, 8 weeks
Waist-hip ratio (WHR)
Concentration of WHR were assessed before and after the intervention
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start2 Jun 2016
- Primary completion24 Apr 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyungpook National University Hospital
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956914
- Sponsor's protocol ID
- CTCF2_2016_DSW
- Status last verified
- Jan 2020
- First submitted
- 17 May 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 8-weeks, Randomized, Double-blind, Placebo-Controlled, Cross-Over Clinical Trials to Evaluated the Efficacy and Safety of Deep Sea Water on Blood Glucose Level
- ClinicalTrials.gov ID
- NCT03956914
- Acronym / sponsor ID
- CTCF2_2016_DSW
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Collaborators
- Kyungpook National University Hospital
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 24 Apr 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to investigate the effects of daily supplementation of deep sea water on improvement of hyperglycemia
Detailed description
This study was a 8 weeks, randomized, double-blind, placebo-controlled, cross-over clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSW (deep sea water) group | Experimental | Other: Deep sea waterDSW, 440 ml/day for 8 weeks |
| Placebo group | Placebo comparator | Other: PlaceboPlacebo, 440 ml/day for 8 weeks |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fasting plasma glucose concentration of 100-140 mg/dL or 2h-postprandial plasma glucose concentration of 140 ~199 mg/dL
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlaceob water 440 ml/day for 8 weeks | Other | Placebo group |
| Deep sea waterDeep sea water 440 ml/day for 8 weeks | Other | DSW (deep sea water) group |
Primary outcome
Changes of blood glucose
Time frame: Baseline, 8 weeks
Concentration of fasting and postprandial glucose during OGTT (oral glucose tolerance test) were assessed before and after the intervention
14 secondary outcomes
Changes of blood insulin
Time frame: Baseline, 8 weeks
C-pepetide
Time frame: Baseline, 8 weeks
HbA1c
Time frame: Baseline, 8 weeks
Homeostatic model assessment - insulin resistance (HOMA-IR)
Time frame: Baseline, 8 weeks
Total cholesterol
Time frame: Baseline, 8 weeks
Triglyceride
Time frame: Baseline, 8 weeks
HDL-cholesterol
Time frame: Baseline, 8 weeks
LDL-cholesterol
Time frame: Baseline, 8 weeks
Weight
Time frame: Baseline, 8 weeks
BMI
Time frame: Baseline, 8 weeks
Body fat mass
Time frame: Baseline, 8 weeks
Percent of body fat mass
Time frame: Baseline, 8 weeks
Waist circumference
Time frame: Baseline, 8 weeks
Waist-hip ratio (WHR)
Time frame: Baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Deep sea water in people with PreDiabetes, run by Chonbuk National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of blood glucose (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.