CTRI/2023/11/059798
Recruiting
Phase 2
A Prospective, Interventional, Randomized, Double-Blind, Parallel, Multi-Arm, Controlled, Phase 2 Clinical Study to Evaluate the Efficacy and Safety of SlimSEB and ProbioSEB CSC3 in Overweight and Obese Subjects with the Risks of Type 2 Diabetes Mellitus - NA
Advanced Enzymes Technologies Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: E66- Overweight and obesity
- Sponsor
- Advanced Enzymes Technologies Ltd
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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