Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: BF-24: 2 capsules once daily one hour before respective meal time for 56 days
Intervention2: BF-24 (Fiber complex), 1gm: 2 capsules twice daily one hour before respective meal time (lun
Sponsors
Akay Natural Ingredients Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Overweight Subject: BMI greater than or equal to 25.00 to lesser than or equal to 30.00 kg/m2. 2. Subject willing to adhere with their routine diet and exercise regimen throughout the study. 3. Females of childbearing age, who agree to use approved birth control methods during the study and have negative urine pregnancy test (UPT) at screening. 4. Must be willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects suffering from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain six months prior to screening. 2. Pathophysiologic/genetic syndromes associated with obesity 3. Intake of over the counterweight loss agents, appetite suppressants in the previous six months 4. Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease); 5. Subjects allergic to herbal products or any component of the study product. 6. Subjects those who skip the breakfast 7. Subjects those who have gastrointestinal discomforts while taking fiber supplements 8. Subjects who consume caffeinated and carbonated beverages daily 9. Known HIV or Hepatitis B positive or any other immuno-compromised state 10.History of Chronic metabolic disease, Psychiatric illness,Drug abuse, smoking, abuse/addiction to alcohol,Eating disorder such as bulimia or binge eating, Endocrine abnormalities including stable thyroid disease, Cardiovascular surgery, History of any major surgery including bariatric surgery 11. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 12. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of BF-24 in comparison with placebo on appetite suppression, anthropometric parameters and body composition.Timepoint: Day 1, Day 3 (TF), Day 7 (TF), Day 14 (TF), Day 28, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of BF-24 on Blood BiomarkersTimepoint: Day 1, Day 28, Day 56;Overall Safety of BF-24Timepoint: Day 1, Day 3 (TF), Day 7 (TF), Day 14 (TF), Day 28, Day 56 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt.Ltd
Outcome results
None listed