CTRI/2021/08/035420进行中（未招募）2 期
A Prospective, Interventional, Randomized, Double-Blind, Parallel, Multi-Arm, Controlled, Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Bacillus coagulans LBSC And Multi-Strain Probiotics in Healthy Overweight and Obese Subjects with the Risks of Type 2 Diabetes Mellitus and Cardiovascular Diseases
Advanced Enzymes Technologies Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male/female participant of ââ?°Â¥30 and ââ?°Â¤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
排除标准
- •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) ââ?°Â¥ 7.0mmol/L (ââ?°Â¥ 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
研究者
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