Health Condition 1: E66- Overweight and obesity
Conditions
Interventions
Intervention1: SlimSEB
ProBioSEB CSC3
Maltodextrin: 2 capsules twice a day
Intervention2: SlimSEB
ProbioSEB CSC3: 2 Capsules twice a day for 84 days
Intervention3: ProbioSEB CSC3: 2 Capsules twice a
Sponsors
Advanced Enzymes Technologies Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male/female participant of = 30 and = 65 years of age. 2. Participant who can and willing to provide written Informed Consent. 3. Participants meeting WHO defined criteria for overweight (BMI, 26-29.9 kg/m2) or obese (BMI, = 30 kg/m2). 4. Participant with the risks of type 2 diabetes mellitus (fasting glucose) for impaired fasting glycaemia [IFG, 6.1–7.0mmol/L (110–125 mg/dL)]. 5. Participant / participant’s legally acceptable representative understands and can comply with clinical trial protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Participant ? 30 or ? 65 years of age. 2. Participant with type 2 diabetes mellitus [(fasting glucose) = 7.0mmol/L (= 126 mg/dL)]. 3. Participants with other comorbidities or metabolic syndrome or non-alcoholic steatosis. 4. Participants currently undergoing any weight loss treatment through diet restrictions or medicines and are not willing to refrain from that regime at least one month prior to enrollment. 5. Participant on aggressive diet attempts within last 3 months or addicted alcoholics and/or drug abusers. 6. Participant with current or history of treatment that may cause significant weight gain. 7. Participant with eating disorders, e.g., anorexia nervosa, bulimia nervosa and binge-eating disorder. 8. Participant with weight change of 5 kg since last 3 months. 9. Pregnant and/or nursing woman. 10. Participant with any clinically significant illness. 11. Participant contracted with COVID-19 infection. 12. History or presence of coronary, renal, pulmonary, and thyroid disease. 13. Active or a history of inflammatory bowel disease. 14. Has undergone any abdominal surgery, except for hernia repair or appendectomy. 15. Participants receiving medication for lowering serum cholesterol level. 16. Participants either used probiotic products within 6 weeks prior to screening in the current trial or currently receiving other probiotic products. 17. Participant who underwent antibiotics or systemic steroid or anti-psychotic therapy within 14 days prior to screening. 18. Participant with a history of hypersensitivity to any of the components of the investigational products or excipients used in the formulation of investigation product. 19. Participant who has participated in another trial with an investigational product within 1 month prior to this trial. 20. Participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of SlimSEB and ProbioSEB CSC3 in alleviating symptoms in overweight and obese with the risks of type 2 diabetes mellitusTimepoint: Day 42, Day 84, Day 98 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess and compare the efficacy of SlimSEB and ProbioSEB CSC3 in improving vital signs and clinical parameters. 2. To assess the safety and tolerability of SlimSEB and ProbioSEB CSC3 in alleviating symptoms in overweight and obese with the risks of type 2 diabetes mellitus.Timepoint: Day 42, Day 84, Day 98 | — |
Countries
India
Contacts
Public ContactDr Nilisha Nalawade
iDD Research Solutions Pvt Ltd
Outcome results
None listed