The study of Hot Spring Water 99

JRCT ID: jRCT1070220018

Registered date:21/06/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hyperglycemia
• Date of first enrollment: 28/07/2022
• Target sample size: 20
• Study type: Interventional

Intervention(s)

1) Onsensui 99 Period:
Hot spring water 99 (manufactured by SOC Corporation., 500 mL, three times a day)
Drink three times a day (167 mL each time, 500 mL total) before each meal.
2) Saigaiyou Bichikusui period:
Bichikusui (manufactured by AKO KASEI Co.,Ltd., 500 mL, three times a day)
Drink three times a day (167 mL once, 500 mL in total) before each meal.
3) Washout period:
During the washout period, the drinking water and eating habits before the start of this study will remain unchanged as much as possible.

Outcome(s)

• Primary Outcome: Blood sugar level at a month after the start of feeding.

Secondary Outcome

1) Blood sugar-related levels at a month after the start of feeding.
- HbA1c
- Insulin
2) Uric acid related values at 1 month after starting intake.
- Uric acid
3) Uric acid excretion rate in urine at 1 month after the start of intake.
- Urinary uric acid excretion rate
4) Lipid profile values at 1 month after the start of intake.
- High density lipoprotein cholesterol
- Low density lipoprotein cholesterol
- Triglyceride
5) Liver function measurements at 1 month after intake.
- Gamma-glutamyl transpeptidase
- Alkaline phosphatase
6) Intestinal environment at 1 month after intake.
- Intestinal microflora

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients providing written informed and consent to participate in the study.
2) Aged >= 20 years (irrespective of sex).
3) Patients with HbA1c levels in the boundary range(5.6-6.4%).

Exclude criteria

1) Patients who have taken, or plan to take during this study, medications that may affect this study (antiallergic drugs, bowel preparations, laxatives, etc.) since the pre- test.
2) Patients who regularly use medicines for diabetes.
3) Patients who have taken antibiotics before one month prior to the start of drinking water for study, or plan to do so during this study period.
4) Patients who have been using food for specified health uses, functional foods, supplements, or health foods that may affect this study for more than 3 days a week prior to participation in this study.
5) Patients with a history of appendicectomy.
6) Patients who have undergone surgery that may affect the test within six months prior to the date of the pre-test (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, etc.)
7) Heavy drinkers of alcohol.
8) Patients with extremely irregular dietary habits or irregular rhythms of life (shift workers, late-night workers, etc.)
9) Patients who are during participating in a clinical trial of another drug or health food, or who plan to participate in another clinical trial within 4 weeks after the completion of this trial or after consenting to participate in this trial.
10) Pregnant women, those who plan or may become pregnant, and those who are breastfeeding.
11) Patients with a history or current history of serious diseases of the heart, liver, kidney, digestive organs, etc.
12) Patients with allergies to medicines or food.
13) Patients who have donated component blood or 200mL whole blood for the month prior to the screening test.
14) Men who donated 400 mL of whole blood for 3 months prior to the screening test.
15) Women who donated 400 mL of whole blood for 4 months prior to the screening test.
16) Men whose blood collection volume from 12 months prior to the screening test plus the total planned blood collection volume for this study exceeds 1200 mL.
17) Women whose blood collection volume from 12 months prior to the screening test plus the total planned blood collection volume for this study exceeds 800 mL.
18) Employees of SOC Corporation and their families.
19) Patinets who are judged inappropriate to participate in this study by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: Ohishi Mitsuru
• Source(s) of Monetary Support: SOC Corporation,Metabologenomics,Inc.