Healthy Volunteers, Non Diabetic Hyperglycemia
Conditions
Keywords
Safety, mulberry, glucose, healthy
Brief summary
Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group. They took the sample 3 times/day for 8 weeks. Complete blood count, Blood urea nitrogen (BUN), Creatinine, Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Fasting plasma glucose, HbA1c, and adverse effects were evaluated before and after 4 and 8 weeks.
Detailed description
Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group. They took the sample 3 times/day for 8 weeks. Complete blood count, Blood urea nitrogen (BUN), Creatinine, Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Fasting plasma glucose, HbA1c, and adverse effects were evaluated before and after 4 and 8 weeks. Satisfaction was assessed after 8 weeks.
Interventions
COMBINATION_PRODUCTMulberry Leaf Extract
They took the Mulberry leaf extract capsule (DNJ 12mg) 3 times/day for 8 weeks.
OTHERPlacebo
They took the sample 3 times/day for 8 weeks.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female age more than 18 years * No Diabetis mellitus disease and no taking diabetes medication * Blood sugar level less than 126 mg/dl and HbA1C less than 6.5 * Can using Thai language * Willing to participate in the study
Exclusion criteria
* Allergic to mulberry extract * Take mulberry extract in 2 weeks before participate in this study * Take medications that have effect on blood sugar level such as steroid in 2 weeks before participate in this study * Have uncontrolled disease * Have AST, ALT, ALP more than 3 times of normal value, or estimated Glomerular Filtration Rate less than 30 ml/min/1.73 m2) * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aspartate transaminase (AST) level | 8 weeks | Aspartate transaminase (AST) is in normal range. |
| Alanine aminotransferase (ALT) level | 8 weeks | Alanine aminotransferase (ALT) is in normal range. |
| Blood urea nitrogel level | 8 weeks | Blood urea nitrogen (BUN) is in normal range. |
| Creatinine level | 8 weeks | Creatinine is in normal range. |
| Complete blood counts | 8 weeks | Complete blood counts are in normal range. |
| Adverse events | 8 weeks | Adverse events are observed. |
| Alkaline phosphatase (ALP) level | 8 weeks | Alkaline phosphatase (ALP) is in normal range. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose level | 8 weeks | Fasting plasma glucose and HbA1c are in normal range. |
Countries
Thailand
Contacts
CONTACTPornanong Aramwit, Ph.D
Outcome results
None listed