Health Condition 1: R739- Hyperglycemia, unspecified
Conditions
Interventions
Intervention1: Metaberine: 200 mg of Metaberine
Dosage One capsule once daily orally 30 min before meal for 12 weeks
Route of administration Oral
Control Intervention1: Placebo: Microcrystalline Cell
Sponsors
Zeus Hygia LifeSciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged between 18 and 65 years. 2 Healthy adults having HbA1c levels between 5.4 to 6.4 3 Fasting Blood Sugar defined by 85 to 125 mg/dL 4 Individuals who having a body mass index 25 to 29.9 5 Not on glucose-lowering medication or on stable lifestyle intervention only for at least 3 months 6 Willing to follow standardized lifestyle advice and provide written informed consent and comply with study procedures 7 Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test UPT at screening
Exclusion criteria
Exclusion criteria: 1.HbA1c levels greater than or equal 6.5% or FBS greater than or equal 126 mg/dL. 2.Pregnancy / lactation. 3.Clinically diagnosed with chronic diseases. 4.Who are currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychological, infectious diseases, malignant tumors, etc. 5.Uncontrolled high blood pressure (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher) 6.Current use of berberine supplements within 3 months or any other supplements. 7.Known hypersensitivity to trial products. 8.Participation in another interventional trial within 3 months. 9.Diagnosed with type 1 or type 2 diabetes. 10.Currently taking medications or dietary supplements related to diabetes. 11.History of excessive alcohol consumption or substance abuse. 12.Uncontrolled thyroid disorders. 13.In the judgment of the principal investigator, who are unlikely to comply with study procedures or have conditions that could interfere with study completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in HbA1c (%) from screening and Week 12 2.Change in fasting and post-prandial blood sugar levels from screening to Week 1,2,4, 8 and 12 3.To assess GLP-1 estimation (7-36 amide) (Baseline and Week 12) for both the groups Timepoint: screening to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in lipid parameters: o LDL, HDL, Total cholesterol and Triglycerides 2. changes in Body weight, BMI, Fat Mass, Visceral Fat, Lean Body Mass using CULT Body Composition Monitor and Waist hip Circumference Ratio 3. To assess changes in insulin resistance as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Note: GLP-1, HOMA-IR and Leptin assessments will be performed in the same set of participants. 4. To measure the Quality of life using SF 36 Questionnaire. 5. Participant reported outcomes will be assessed using a battery of validated questionnaires, including the MFI 20, PSQI,FCQ, VAS for appetite, GSRS. 6. Incidence of adverse events 7. Safety laboratory parameters: CBC, LFT and RFT 8. To assess changes in serum Leptin levels (appetite regulation) Timepoint: screening to Week 12 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar PhD
Ki3 Private Limited
Outcome results
None listed