Clinical trial NCT03956914: Efficacy and Safety of Deep Sea Water on the Blood Glucose Level
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
Collaborators: name: Kyungpook National University Hospital
First posted: 2019-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of blood glucose
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Changes of blood insulin
timeFrame: Baseline, 8 weeks
measure: C-pepetide
timeFrame: Baseline, 8 weeks
measure: HbA1c
timeFrame: Baseline, 8 weeks
measure: Homeostatic model assessment - insulin resistance (HOMA-IR)
timeFrame: Baseline, 8 weeks
measure: Total cholesterol
timeFrame: Baseline, 8 weeks
measure: Triglyceride
timeFrame: Baseline, 8 weeks
measure: HDL-cholesterol
timeFrame: Baseline, 8 weeks
measure: LDL-cholesterol
timeFrame: Baseline, 8 weeks
measure: Weight
timeFrame: Baseline, 8 weeks
measure: BMI
timeFrame: Baseline, 8 weeks
measure: Body fat mass
timeFrame: Baseline, 8 weeks
measure: Percent of body fat mass
timeFrame: Baseline, 8 weeks
measure: Waist circumference
timeFrame: Baseline, 8 weeks
measure: Waist-hip ratio (WHR)
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
Study officials:
References: