Health Condition 1: R730- Abnormal glucose
Conditions
Interventions
Intervention1: 250 mg Tablet: 3 tablets daily one tablet before breakfast, one before lunch, and one before dinner.
Daily consumption (15 mins before proper meal) for duration of 28 Days
Interventio
Sponsors
Ambe Phytoextracts Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult males and non-lactating/non-pregnant female participants between ages of 18 to 55 years (both inclusive at the time of consent). 2. Participants with BMI between 25 32 kg/m (Overweight to Class I Obese). 3. Prediabetic participants with HbA1c between 5.7 6.4%. 4. Participants having good general health as determined by the Investigator on the basis of medical history and physical examination. 5. Participants of childbearing potential: o must have a negative urine pregnancy test performed during screening. o willing to follow all the acceptable forms of contraception as applicable. 6. Participants willing to consume test products throughout the study period as instructed. 7. Participants who are not planning to relocate or planning to take vacation for more than 2 to 3 days. 8. Participants who are willing to maintain a consistent diet and lifestyle routine throughout the study. 9. Participants who are willing to voluntarily participate in the study and provide signed informed consent. 10. Participants should be willing and able to follow the study protocol to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Participants with known allergy to the legumes, extract or related herbal extracts. 2. Participants with known allergy or hypersensitivity to any ingredients of the test products. 3. Participants who are planning pregnancy during the study period. 4. Participants who are diagnosed with diabetes mellitus (FBG more than or equal to 126 mg/dL or HbA1c more than or equal to 6.5%). 5. Participants who are using antidiabetic, lipid-lowering, or weight-loss medications in the past 2 months. 6. Participants who have a history or are diagnosed gastrointestinal disease that may affect digestion or gut hormone secretion. 7. Participants using medications or supplements known to affect gut hormones. 8. Participants who have tested positive for HIV test. 9. Participants having any chronic illness or health condition such as hyperthyroidism or hypothyroidism, diabetes, Peripheral Artery Disease, CKD, previous major surgery, hepatitis etc. that can interfere with the outcome of the study. 10. Participants undergone any surgical procedure undergone within the past 12 weeks. 11. Participants with a history or presence of significant alcoholism or drug abuse and smoking (more than or equal to 10 cigarettes/day) or consumption of tobacco products. 12. Any other significant disease or disorder that, in the opinion of the investigator, may affect the trial results or the participants ability to participate effectively. 13.Participants who have participated in another clinical trial within the 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the impact of the product on serum GLP-1 levels, assessed using incremental area under the curve (iAUC), maximum observed concentration (Cmax), and time to maximum concentration (Tmax)Timepoint: Visit 01 and Visit 02 (Fasting Condition and at 30 mins 60 mins, 90 mins & 120 mins following product consumption) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the impact of the product on serum peptide YY (PYY) and serum ghrelin levels (dose-response trends)Timepoint: Visit 01 and Visit 02 (Fasting Condition and at 30 mins 60 mins, 90 mins & 120 mins following product consumption) ;To evaluate the impact of product on blood glucose levels, assessed using incremental area under the curve (iAUC), maximum observed concentration (Cmax), and time to maximum concentration (Tmax)Timepoint: Visit 01 and Visit 02 (Fasting Condition and at 30 mins 60 mins, 90 mins & 120 mins following product consumption);To evaluate the impact of product on blood insulin levels, assessed using incremental area under the curve (iAUC), maximum observed concentration (Cmax), and time to maximum concentration (Tmax)Timepoint: Visit 01 and Visit 02 (Fasting Condition and at 30 mins 60 mins, 90 mins & 120 mins following product consumption);To explore the relation between GLP-1 and Post prandial glucose excursion (Exploratory endpoint).Timepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactShashi Singh
Cliantha Research
Outcome results
None listed