Phase 2 Study to Evaluate the Effectiveness and Safety of Probiotics in Healthy Overweight and Obese patients with the Risks of Type 2 Diabetes Mellitus and Cardiovascular Diseases

Phase 2

• Registration Number: CTRI/2021/08/035420
• Lead Sponsor: Advanced Enzymes Technologies Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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, 25ââ?¬â??29.9 kg/m2) or obese (BMI, ââ?°Â¥30 kg/m2)

4. Participant with the risks of type 2 diabetes mellitus and cardiovascular diseases following WHO recommended diagnostic criteria (fasting glucose) for impaired fasting glycaemia[IFG, 6.1ââ?¬â??7.0mmol/L (110ââ?¬â??125 mg/dL)] or impaired glucose tolerance [IGT, <7.0 mmol/L ( <126 mg/dL)].

5. Participant without any co-morbidities /medical illness

6. Participant / participantââ?¬Ë?s legally acceptable representative understands and can comply with clinical trial protocol requirements

Exclusion Criteria

1.Participant Ã?â?? 30 or Ã?Æ? 65 years of age

2. Participant with type 2 diabetes mellitus and cardiovascular diseases following WHO recommended diagnostic criteria (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

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 type 2 diabetes mellitus or cardiovascular diseases or 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective for this study is: To assess and compare the efficacy of B. coagulans LBSC and multi-strain probiotics in alleviating symptoms in healthy overweight and obese subjects with the risks of type 2 diabetes mellitus and cardiovascular diseases.Timepoint: From Screening Visit/ Baseline Visit, (Day -2) to Visit 5, End of Treatment Visit (Day 84)

Secondary Outcome Measures

Name	Time	Method
The secondary objective for this study is:1.To assess and compare the efficacy of B. coagulans LBSC and multi-strain probiotics in improving vital signs, clinical parameters and overall quality of life. <br/ ><br>2.To assess the safety and tolerability of B. coagulans LBSC and multi-strain probiotics in alleviating symptoms in healthy overweight and obese subjects with the risks of type 2 diabetes mellitus and cardiovascular diseases.Timepoint: From Visit 1, Screening Visit/ Baseline Visit, (Day -2) to Visit 5, End of Treatment Visit (Day 84)