Health Condition 1: null- Obese Overweight Hyperlipidemic and Prediabetic Adults
Conditions
Interventions
Intervention1: Salacia: BID Dose one capsule take at afternoon and one capsule at night
Control Intervention1: Placebo: BID Dose one capsule take at afternoon and one capsule at night
Sponsors
OmniActive Health Technologies Ltd
OmniActive Health Technologies Canada Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Men and non pregnant women of 18-65 (inclusive of both) years of age • Be willing to follow the scheduled visit appointments • Willing to provide the written informed consent for participation in the study • Body Mass Index (BMI) of 30.0 kg/m2 or above • Body Mass Index (BMI) of 28.0 kg/m2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension • Stable body weight for a period of past 3 months prior to screening • Pre diabetic status: a HbA1C level of 5.7 to 6.4 percent; an Fasting Plasma Glucose (FPG) test result of 100â??125 mg/dL, indicating impaired fasting glucose (IFG) level; or a 2-hour Oral Glucose Tolerance Test (OGTT) result of 140â??199 mg/dL, indicating Impaired Glucose Tolerance (IGT).
Exclusion criteria
Exclusion criteria: Known type 1 or type 2 diabetes as confirmed by glycosylated haemoglobin of 6.5 percentage or above FPG of 126 mg/dL 7 mmol/L or above 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL 11.1 mmol/L or above Screening calcitonin of 50 ng/L or above; family or personal history of multiple endocrine neoplasia type 2 Past history of non-familial medullary thyroid carcinoma or Familial Medullary Thyroid Carcinoma or history of acute/chronic pancreatitis Drug induced obesity Use of approved weight lowering pharmacotherapy Previous surgical treatment of obesity History of major depressive disorder or suicide attempt Uncontrolled hypertension systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above Participation in any research involving an investigational product within a period of one month prior to screening Subjects unable to adhere to a regular follow up schedule History of any known hypersensitivity or allergy of any sort such as asthma, eczema, atopy or drug allergy etc that would place the subject at increased risk, as determined by the investigator History of chronic alcohol, smoking, chemical, drug abuse or dependence History or presence of clinically significant systemic disorder involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine, autoimmune, immunodeficiency e.g., human immunodeficiency virus [HIV] infection, or nervous system or psychiatric disease or other conditions that may interfere with the study or would place the subject at increased risk, as determined by the investigator Pregnant breast feeding mothers and women planning to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in BMI Body composition measurements (Waist Circumference, Hip Circumference and Waist and Hip Ratio at the end of the studyTimepoint: Baseline and end of study i.e 2 months after supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| Pre-diabetes status analyzing change from baseline in FPG, HbA1c levels and lipid profile at the end of the study. Change from baseline in visceral fat, Insulin, CRP, GLP-1, ghrelin, adiponectin and leptin levels at the end of study. Change from baseline in lipolytic markersat the end of study. Change from baseline in Body composition at the end of study Change from baseline in quality of life scores at the end of the study To assess the safety of a test productTimepoint: Baseline and end of study i.e 2 months after supplementation | — |
Countries
India
Contacts
Public ContactAbhijeet Morde
Sri Ramachandra Hospital
Outcome results
None listed