None listed
Conditions
Interventions
Intervention1: Weight Management Gummies: 1 gummy twice a day for 90 days
Control Intervention1: Nil: Nil
Sponsors
Aesthetic Nutrition Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Obese patients (male/female and aged between 20-45 yrs.) BMI between 30 - 37 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 |
|---|---|
| Changes in Body Weight Changes in BMI 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 Timepoint: Baseline,day 30,day 60,day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in digestive behavior (Bloating, Heartburn, Flatulence, Constipation, Post Prandial Fullness etc.) in subjects 2. Changes in insulin resistance calculated as HOMA-IR score 3. Changes in anthropometric parameters such as Waste/Hip Ratio, Mid upper arm Circumference, Body Fat %, Visceral Fat level % etc. 4. Changes in general complaints like profuse sweating, irregular thirst, dyspnea and uncontrolled hunger on 0-10 VAS score. Timepoint: Baseline, day 30, day 60, day 90 | — |
Countries
India
Contacts
Public ContactMr Kapil Mittal
Mprex Healthcare Pvt. Ltd.
Outcome results
None listed