Efficacy and Safety of Deep Sea Water on the Blood Glucose Level
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
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
This study was conducted to investigate the effects of daily supplementation of deep sea water on improvement of hyperglycemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
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
June 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2017
CompletedFirst Submitted
Initial submission to the registry
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedJanuary 18, 2020
January 1, 2020
11 months
May 17, 2019
January 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes of blood glucose
Concentration of fasting and postprandial glucose during OGTT (oral glucose tolerance test) were assessed before and after the intervention
Baseline, 8 weeks
Secondary Outcomes (14)
Changes of blood insulin
Baseline, 8 weeks
C-pepetide
Baseline, 8 weeks
HbA1c
Baseline, 8 weeks
Homeostatic model assessment - insulin resistance (HOMA-IR)
Baseline, 8 weeks
Total cholesterol
Baseline, 8 weeks
- +9 more secondary outcomes
Study Arms (2)
DSW (deep sea water) group
EXPERIMENTALDSW, 440 ml/day for 8 weeks
Placebo group
PLACEBO COMPARATORPlacebo, 440 ml/day for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Fasting plasma glucose concentration of 100-140 mg/dL or 2h-postprandial plasma glucose concentration of 140 \~199 mg/dL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 17, 2019
First Posted
May 21, 2019
Study Start
June 2, 2016
Primary Completion
April 24, 2017
Study Completion
August 28, 2017
Last Updated
January 18, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share