Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Beach Body Gummies: 1 gummy twice a day after breakfast and dinner along with
lifestyle modification (diet and exercise) for 90 days
Control Intervention1: Lifestyle modification (diet
Sponsors
Aesthetic Nutrition Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Obese patients (male/female and aged between 20-45 yrs. both inclusive); 2. BMI between 30 - 40 kg/m2; 3. Subjects with or without comorbidities, if comorbidity exists should be on stable prescription and with following criteria- hypertension (Less than or equal to 140/90 mmHg on prescription), type 2 DM (HbA1C Less than or equal to 7.5 on prescription); 4. Willing to provide consent; 5. Willing for follow up
Exclusion criteria
Exclusion criteria: 1. Subjects with any acute illness requiring immediate medical care; 2. Subjects with type I DM/complicated cardiovascular diseases / HbA1C more than 7.5. / history of TIA, cerebrovascular accident, stroke or any revascularization; 3. Known subjects of hepatic/renal failure; 4. Pregnant, breast feeding or planning to become pregnant during the study; 5. Any other condition which proves subject unfit for the study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in body weight from screening to end of the study. 2. Changes in BMI from screening to end of the study. 3. Changes in anthropometric parameters such as waist & hip circumference and body fat %, visceral fat % by bioelectrical impedance analysis (BIA) at screening and end of the study.Timepoint: Screening Day ,Baseline Day, Day 30(visit 1), Day 60(visit 2), Day 90(visit 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in quality of life of subjects by modified IWQOL-Lite score at screening and end of the study. 2. Changes in insulin resistance calculated as HOMA-IR score at screening and end of the study. 3. Changes in lipid profile at screening and end of the study. 4. Changes in general complaints like profuse sweating, irregular thirst, dyspnea and uncontrolled hunger on 0-10 VAS score from screening to end of the study.Timepoint: Screening Day ,Baseline Day, Day 30(visit 1), Day 60(visit 2), Day 90(visit 3) | — |
Countries
India
Contacts
Public ContactMs Ekta Pathania
Aesthetic Nutrition Pvt. Ltd.
Outcome results
None listed