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.

A multicentre, placebo controlled, randomized, multiple dose, parallel group; clinical study to compare the efficacy and safety of Green tea film (Test Product) of Shilpa Therapeutics Pvt., Limited, India, Tetley (green tea) bags (Reference Product) of Tata Global Beverages Limited and standard dispersible strips (Placebo) in overweight or obese adult subjects.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/020178

Enrollment

Registered

2019-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Green tea film: Dispersible strips, three times a day before meal (Breakfast, Lunch and Dinner) for 90 days of treatment period Control Intervention1: Tetley (green tea) bags: Normal G

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
% Change in antioxidant capacity % Change in body weight or mass measure (absolute or percentage change in body weight) % Change in body mass index (BMI) % change in waist circumference % change in hip circumference % change in waist-to-hip circumference ratioTimepoint: 3 months	—

Secondary

Measure	Time frame
Compliance/adherence Subject satisfaction Morbidity Adverse effects of treatmentTimepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Milan Satia

Ethicare Clinical Trial Services

milansatia@ethicare-cro.com9825585119

Outcome results