An open label, single arm, prospective, multicentric, interventional clinical study to evaluate the effect of Meal Replacement Supplement on weight management in overweight / obese patients. - NI

Dr. Reddys Laboratories Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

暂无简介。

•1) Subjects with BMI from 23 kg/m2 to 32 kg/m2.
•2) Subjects with a history of stable weight, defined as no significant weight change (± 5%) within three months prior to enrollment.
•3) Subjects not participating in similar program or not using any natural/ herbal supplement or any other drug/nutraceutical for weight loss.
•4) Subjects able to adjust diet or take nutrition and supplements daily with the guidance of a nutritionist.
•5) Female subjects of childbearing potential must have a negative urine pregnancy test performed at screening visit.
•6) Subjects who are willing to participate in the study and give voluntary written informed consent.
•7) Subjects who are willing and able to follow the study protocol to participate in the study.

•1) Subjects consuming probiotics / prebiotics 30 days prior to study.
•2) Subjects using supplements that are rich in dietary fibre or protein which influences satiety assessment.
•3) Subjects taking appetite stimulants or on steroid treatment or on hormone therapy.
•4) Subjects who have a history of Insulin dependent diabetes / with Type I diabetes / with uncontrolled Type 2 diabetes.
•5) Subjects who have hypothyroidism or hyperthyroidism as confirmed by lab test (T3, T4, TSH).
•6) Subjects having limitation in doing physical activity/exercise for at least 20 to 30 mins daily.
•7) Subjects who have undergone hospitalization for an infectious condition within 4 weeks prior to study entry.
•8) Subjects participating in other similar therapeutic trials within the last four weeks.

发起方

Dr. Reddys Laboratories Ltd.