None listed
Conditions
Interventions
None listed
Sponsors
Naturedge Beverages Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Obese patients (male/female and aged between 20-45 yrs.) BMI between 30 - 40 kg/m2 Subjects with or without comorbidities, if comorbidity exists should be on stable prescription and with the following criteria- Hypertension (140/90 mmHg on prescription), Type 2 DM (HbA1C Willing to provide consent Willing for follow up
Exclusion criteria
Exclusion criteria: Subjects with any acute illness requiring immediate medical care. Subjects with Type I DM/Complicated cardiovascular diseases / HbA1C >= 7.5. / History of TIA, Cerebrovascular accident, stroke or any revascularization. Known subjects of hepatic failure/inflammation. Pregnant, breast feeding or planning to become pregnant during the study. Any other condition which proves subject unfit for the study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in Body Weight 2.Changes in BMI 3.Changes in Quality of life of subjects by IWQOL-Lite score (The Impact of Weight on Quality of Life Questionnaire) in social and emotional aspect 4.Changes in Eating Disorder examination questionnaire score 5.Changes in energy audit questionnaire score Timepoint: screening , baseline and day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in digestive behavior (Bloating, Heartburn, Flatulence, Constipation, Post Prandial Fullness etc.) in subjects 2. Changes in anthropometric parameters such as Waste/Hip Ratio, Mid upper arm Circumference, Body Fat %, Visceral Fat level % etc. 3. Changes in general complaints like profuse sweating, irregular thirst, dyspnea and uncontrolled hunger on 0-10 VAS score. 4.Changes in Lipid profile Timepoint: screening , baseline and day 60 | — |
Countries
India
Contacts
Public ContactMr Sharad Dhurde
Naturedge Beverages Pvt. Ltd.
Outcome results
None listed