Health Condition 1: R730- Abnormal glucose
Conditions
Sponsors
Leads Clinical Research and Bio Services Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with fasting blood glucose levels between 100 mg per dL and 125 mg per dL.2.Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.3.Subject willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1.Subjects requiring diabetes treatment at the time of screening.2.Subjects with glycated hemoglobin (HbA1c) levels greater or equal to 6.5%.3.Subjects who have taken medications or functional foods related to blood glucose within three months prior to the screening.4.Subjects diagnosed with type 1 or type 2 diabetes.5.Subjects with clinically diagnosed chronic diseases. 6.Subjects currently taking medications or dietary supplements related to diabetes.7.Subjects with a history of serious diseases affecting the gastrointestinal tract, liver, kidneys, cardiovascular system, respiratory system, or endocrine system.8.Subjects with a history of excessive alcohol consumption or substance abuse.9.Subjects with uncontrolled thyroid disorders.10.Women who are currently pregnant, breastfeeding, or planning to become pregnant during the study period.11.Women of childbearing potential who are unable to use approved contraceptive methods.12.Subjects unable to read or understand English.13.Subjects who do not meet the screening criteria at the baseline visit.14.Subjects currently enrolled in another clinical trial or who have participated in a clinical trial within the past 30 days.15.Subjects with allergies to study-related interventions.16.Subjects with a history of significant adverse reactions to similar investigational products.17.Subjects who, in the judgment of the principal investigator, are unlikely to comply with study procedures or have conditions that could interfere with study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the postprandial blood glucose levelsTimepoint: Day 0,Day 42 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Insulin tolerance test and HbA1CTimepoint: Day 0 and Day 84;Mean change in biomarkersTimepoint: Day 0 and Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt.Ltd
Outcome results
None listed