Double-blind placebo controlled clinical study to evaluate the effect of supplementation with Astrobiome during 4 weeks in insulin resistance and inflammation in Type 2 diabetic patients

INNOVATION LABO Sciences Co., Ltd0 个研究点目标入组 50 人开始时间: 2023年7月7日最近更新: 2023年7月18日

适应症

试验速览

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•1. Non-smoker female and male subjects between 25 to 60 years (inclusive) of age with Type 2 diabetes (FPG ( = 126.0 mg/dl or 7.0mmol/L) for more than 6 months
•2. Subjects with a BMI range of 25-35 kg/m2 (both inclusive)
•3. Subjects using any medicines for diabetes must be stable on those medicines for a minimum of 3 months
•4. Subject agreeing not to start any new anti-diabetic medicines or supplements during the course of the study
•5. Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result at the screening visit.
•Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
•6. Willing to give written informed consent and willing to comply with the trial protocol
•7. Ability to understand the risks/benefits of the protocol
•8. Subject should be available for the duration of the study period (1 month)

•1. Subjects suffering from gastrointestinal, CVD, renal, thyroid, liver or pancreatic diseases.
•2. Subjects taking vitamins, prebiotics or probiotics.
•3. Subjects having liver diseases.
•4. Subjects on prolonged (Greater than 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, antipsychotic drugs, etc. or any other drugs that may have an influence on the outcome of the study.
•5. Subjects with a history of alcohol or drug abuse
•6. Pregnant/lactating woman
•7. Subjects using other modulators like diet control, yoga, herbal supplements, etc and wish to continue after enrolment.

发起方

INNOVATION LABO Sciences Co., Ltd