To evaluate how safe and effective Salacia is in Obese or Overweight subjects
- Conditions
- Health Condition 1: null- Obese Overweight Hyperlipidemic and Prediabetic Adults
- Registration Number
- CTRI/2018/03/012414
- Lead Sponsor
- OmniActive Health Technologies Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
•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).
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in <br/ ><br>BMI <br/ ><br>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 Outcome Measures
Name Time Method Pre-diabetes status analyzing change from baseline in FPG, HbA1c levels and lipid profile at the end of the study. <br/ ><br>Change from baseline in visceral fat, Insulin, CRP, GLP-1, ghrelin, adiponectin and leptin levels at the end of study. <br/ ><br>Change from baseline in lipolytic markersat the end of study. <br/ ><br>Change from baseline in Body composition at the end of study <br/ ><br>Change from baseline in quality of life scores at the end of the study <br/ ><br>To assess the safety of a test productTimepoint: Baseline and end of study i.e 2 months after supplementation