A study to compare the Green tea extract dispersible strips (Test Product), Tetley (green tea) bags (Reference Product) and standard dispersible strips (Placebo) in overweight or obese adult subjects for its efficacy and safety.
- Registration Number
- CTRI/2019/07/020178
- Lead Sponsor
- Shilpa Therapeutics Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
1.Male and non-pregnant females with the age of greater than or equal to 18 to less than or equal to 55 years.
2.Obese subjects with a body mass index (BMI) of 28-35 kg/m2.
3.Abdominal obesity (Waist circumference): Male >90 cm, Female >85cm.
4.Subjects must be weight stable (within 3-kg) 2 months prior to study inclusion.
5.Fasting glucose less than 126 mg/dL.
6.Normotensive (blood pressure less than 140/90 mmHg).
7.Non-dietary supplement user.
8.Subjects who are willing and able to take part and attend all required clinical trial visits, able to understand the information given to them and give written consent.
1.Subject consumption of greater than or equal to 3 cups of green tea/day.
2.Habitual caffeine intake of greater than or equal to 300 mg ( > 3 or 4 cups of coffee/day).
3.Subject with diabetes, liver disease, gastrointestinal disease, cardiovascular disease and/or with abnormal thyroid function.
4.Subject using hypertensive, lipid-lowering or anti-obesity medications.
5.Known hypersensitivity or allergy to green tea, EGCG, or both.
6.On a weight reduction programme.
7.On a medically supervised diet.
8. > 5 kg weight loss within month prior to study.
9. Smoker ( > 10 cigarettes/day), Habit of tobacco chewing.
10.Alcoholic.
11.Participation in a clinical trial in the previous month which could, in the opinion of the investigator, affect the outcome of the investigation.
12.Donated blood in 3 months prior to study.
13.Had antibiotic therapy for more than 7 days in the 3 months prior to study.
14.Women who are pregnant or suspected to be pregnant or breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % Change in antioxidant capacity <br/ ><br>% Change in body weight or mass measure (absolute or percentage change in body weight) <br/ ><br>% Change in body mass index (BMI) <br/ ><br>% change in waist circumference <br/ ><br>% change in hip circumference <br/ ><br>% change in waist-to-hip circumference ratioTimepoint: 3 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method Compliance/adherence <br/ ><br>Subject satisfaction <br/ ><br>Morbidity <br/ ><br>Adverse effects of treatmentTimepoint: 3 months