prediabetes prediabetes, fasting plasma glucose, HbA1c, ginger
Conditions
Interventions
Participants will receive ginger capsules administered orally at a dose of 2 capsules twice daily after breakfast and dinner, for a total of 4 capsules per day, continuously for 12 weeks.
,Participant
Experimental Dietary Supplement,Placebo Comparator No treatment
Ginger group,Placebo group
Sponsors
Chulabhorn Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Thai male or female participants aged 18 to 70 years diagnosed with prediabetes, defined as fasting plasma glucose 100 to 125 mg per dL after 8 to 12 hours fasting and HbA1c 5.7 to 6.4 percent. 2. Willing and able to abstain from alcohol consumption and smoking for at least 1 week prior to study entry and throughout the study period. 3. Willing to discontinue herbal products or non vitamin dietary supplements, and any medications deemed necessary by the investigator, for at least 1 month prior to enrollment and throughout the study. 4. Willing to maintain their usual level of physical activity during the study period.
Exclusion criteria
Exclusion criteria: 1. Current use of antidiabetic medications or insulin therapy. 2. Clinically significant hepatic or renal impairment, or laboratory values exceeding 3 times the upper limit of normal. 3. Use of medications that may affect blood glucose levels, such as oral hypoglycemic agents, insulin, or corticosteroids. 4. History of allergy to ginger or ginger extract. 5. Pregnant or lactating women. 6. Presence of active malignancy. 7. Use of herbal products or non vitamin supplements that cannot be discontinued during the study. 8. Any condition that, in the opinion of the investigator, may pose a risk to the participant or interfere with study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose level pre-dose and post-dose at week 4, 8, 12 (Fasting Plasma glucose, HbA1c) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety parameters pre-dose and post-dose at week 4, 8, 12 AST, ALT, creatinine, BUN, total bilirubin, albumin, complete blood count, uric acid, CRP, IL-6 | — |
Countries
Thailand
Contacts
Public ContactJutamaad Satayavivad
Chulabhorn Research Institute
Outcome results
None listed