A 12-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of deep sea water mineral extracts on the blood glucose levels.

A 12-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of deep sea water mineral extracts on the blood glucose levels

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008695

Enrollment

Registered

2023-08-08

Start date

2021-10-18

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Test group: Subjects will take two bottles of deep sea water mineral extract orally one daily for 12 weeks. Control group: Subjects will take two bottles of placebo orally one dai

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aged 19 to 70 years 2) Isolated-impaired glucose tolerance (plasma glucose levels from 140 to 199 mg/dl two hours after a 75 g oral glucose consumption during an oral glucose tolerance test) 3) Voluntary agreement to participate in the clinical trials and provision of informed consent

Exclusion criteria

Exclusion criteria: 1) Fasting plasma glucose level = 140 mg/dl 2) HbA1c=7.0% 3) History of underlying type 1 or type 2 diabetes mellitus 4) Reduction of 10% weight within 3 months 5) Systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg (Those who are stably controlling their blood pressure with medication can participate) 6) Administration of corticosteroids within 4 weeks before screening visit 7) Administration of hypoglycemic agents, anti-obesity drugs, lipid-lowering agents etc. within 3 months or intake of functional foods that affect blood glucose or obesity or lipid metabolism within 2 months before screening visit 8) Administration of mineral supplements within 3 months before screening visit 9) Major medical illness such as cardiovascular, neurologic, hepatic, musculoskeletal system, psychiatric, endocrine system, immune, renal, malignant tumor and pulmonary disease etc. 10) History of alcohol or substance abuse 11) History of disease that can interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery 12) Allergic or hypersensitivity to drug and any of the ingredients in the test products (magnesium) 13) Participation in other clinical trials within 3 months 14) AST or ALT > 3 fold of normal range or serum creatinine > 2.0 mg/dl 15) Female subjects of childbearing potential who are not willing to use appropriate contraception 16) Pregnant, planning to become pregnant, or breast-feeding 17) Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study

Design outcomes

Primary

Measure	Time frame
2-hour postprandial plasma glucose;incremental area under the curve (iAUC)	—

Secondary

Measure	Time frame
Fasting plasma glucose;Postprandial plasma glucose (30, 60, and 90 min);Insulin (0, 30, 60, and 90 min);HOMA-IR, QUICKI, ISI, HOMA-ß; C-peptide;Lipid profile (total cholesterol, triglyceride, HDL-cholesterol and LDL-cholesterol);hs-CRP ;Serum magnesium and calcium levels	—

Countries

Korea, Republic of

Contacts

Public ContactMi-Ra Oh

Jeonbuk National University Hospital

mroh@jbctc.org+82-63-259-3047

Outcome results