Study on health effects of syrup

UMIN ID: UMIN000023868

Registered date:01/09/2016

Basic Information

• Recruitment status: Completed
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 2016/09/20
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Test food (1 pack(15mL)/day) for 14 days > 14-day washout period > control food (1 pack(15mL)/day) for 14 days for 14 days
Control food (1 pack(15mL)/day) for 14 days > 14-day washout period > test food(1 pack(15mL)/day) for 14 days for 14 days

Outcome(s)

• Primary Outcome: Liver function (ALT,AST,gammaGT,ALP,LD,T-Bil)

Secondary Outcome

･Blood RNA analysis
･Fecal (intestinal) mocroflora analysis

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female

Include criteria

1.Body mass index (BMI): from 23 to less than 30.
2.ALT: 26U/L or more in men, 18U/L or more in women.
3.Volunteers being able to make self-judgent to particupate in this study and giving written informed consent.
4.Volunteers having screening test results judged to be appropriate for this study by investigator.

Exclude criteria

1.Patients with dyslipidemia or with diabetes under medical treatment or on the use of medicine.
2.Volunteers having severe history of the diseases (liver, kidney, hert, blood) judged to be inappropriate for this study.
3.Patients with liver diseases of alcoholic steatohepatitis, hepatitis C, hepatitis B, autoimmune hepatitis, cirrhosis, or liver cancer, etc. other than non-alcoholic fatty disease.
4.Volunteers received gastrectomy, enterectomy, or gastro-intestinal diseases, judged to be inappropriate for this study.
5.Volunteers with a risk of causing drug or food (especially maple syrup) allergic symptoms.
6.Volunteers with a risk of causing drug or food (especially maple syrup) allergic symptoms.
7.Women who are pregnant, might be pregnant, or are lactating.
8.Volunteers who participate in other clinical trials within the last one month prior to the current clinical trial.
9.Volunteers with any other medical reasons judged to be inappropriate by chief investigater.
10.Volunteers who habitually consume maple syrup.

Related Information

• Primary Sponsor: Niigata Bio-Research Park, Inc
• Source(s) of Monetary Support: KANAGAWA ACADEMY OF SCIENCE AND TECHNOLOGY