Prediabetes Impaired glucose tolerance Mucuna pruriens L DOPA Blood glucose Oral microbiome Gut microbiome Herbal medicine Clinical trial Traditional medicine
Conditions
Interventions
The test group (Group 1) will receive Mucuna pruriens seed extract in capsule form, 1,500 mg per day (containing L-DOPA 111.75 mg), taken as 2 capsules three times daily before breakfast, lunch, and d
Active Comparator Drug,Placebo Comparator Drug
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 30 to 60 years 2. Diagnosed with prediabetes defined as fasting plasma glucose between 100 to 125 mg per dL and 2 hour plasma glucose after 75 gram OGTT between 140 to 199 mg per dL or HbA1C between 5 point 7 to 6 point 4 percent 3. No diagnosis of impaired kidney function or hepatitis No psychiatric disorders 4. Able to understand the study including potential risks and side effects 5. Willing to participate and sign informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women 2. History of allergy to Mucuna pruriens or legumes or severe adverse reactions such as Stevens Johnson syndrome anaphylaxis or aplastic anemia 3. Positive result from COVID 19 antigen test kit 4. Presence of symptoms such as fatigue cough headache sore throat 5. Current smoker or quit smoking less than 3 months prior Alcohol consumption more than 2 standard drinks per day 6. Use of dietary supplements or vitamins within 7 days prior to the study 7. Use of androgenic drugs hypoglycemic agents or levodopa Consumption of L Dopa containing foods such as broad beans garlic ginkgo within 7 days prior 8. Use of antibiotics prebiotics or probiotics within 1 month prior Gastrointestinal disorders or diarrhea within 7 days prior 9. Inability to complete 14 days of study product consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose (FPG) Day 0 and Day 15 Plasma glucose level at 0 and 120 minutes after 75g glucose load,HbA1c Screening only Blood test,Gut microbiome profile Day 0 and Day 15 Stool sample analysis using sequencing methods,Oral microbiome profile Day 0 and Day 15 Saliva sample analysis using sequencing methods | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile Day 0 and Day 15 Adverse event monitoring, vital signs, liver and kidney function tests | — |
Countries
Thailand
Contacts
Public ContactKamonwan Banchuen
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed