CTRI/2022/05/042791已完成未知
A Prospective, randomized, Open Label study to evaluate the Safety and Efficacy of BugSpeaks basedpersonalized nutrition on patients with Hyperglycemia and Hyperlipidemia.
eucine Rich Bio Pvt Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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. Men and women from 45 to 65 years.
- •2. Body Mass Index (BMI) >= 19 and < 40 kg/m2
- •3. Signed informed consent.
- •4. Free of infections at baseline
- •5. HbA1c more than or equal to 7% - 10% or LDL cholesterol more than or equal to 120 mg/dL.
- •6. Patient who agrees to follow personalized diet for 3 months.
- •7. Subject on stable dose of oral Hypoglycemic medication except Metformin for the past 3 months or lifestyle intervention.
- •8. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on stable dose for at least three months prior to screening visit. These medications will not be changed during intervention unless it is mandatory.
排除标准
- •Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:
- •1. Individuals with severe diseases (hepatic, kidney, cancerâ?¦).
- •2. Individuals with Chronic Intestinal Pathologies (Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis, Crohns Disease).
- •3. Individuals with dementia, mental disease or low cognitive function.
- •4. Individuals with autoimmune diseases and/or under treatment with corticosteroids and/or
- •immunosuppressants.
- •5. Individuals with major surgeries during the last month or gastrointestinal surgery in the last 3 months.
- •6. Individuals treated with oral antibiotics during two weeks prior to the beginning of the study.
- •7. Individuals undergoing dietary restriction and/or pharmacological treatment for the decrease of body weight 2 months prior to the beginning of the study.
- •8. Women that consume oral contraceptive.
- •9. Pregnant women or breastfeeding.
- •10. Individuals with intensive physical activity ( > 2 hours, more than 3 times per week).
- •11. Individuals that consume antioxidant supplement, drugs, Ï?-3 supplements, vitamins, minerals, prebiotics or/and probiotics during the 2 weeks prior to the beginning of the study and that will not eliminate their consumption during the study.
- •12. Individuals with regular consumption ( > 3 servings per week) of fermented foods (yogurt, actimel, kefir, blue cheeseâ?¦) and/or use of other prebiotics and not to accept suppress their consumption during the study.
- •13. Individuals with increased alcohol consumption >30g/day (equivalent to 300 ml of wine, about 3 beers or a cup (75 ml) of whiskey, brandy, anise, etc.)
- •14. Individuals with regular use of laxatives ( > 2 a week) and (Laxbene, Miralax, Dulco - Lax, etc.) and does not accept suppress its consumption during the study period.
- •15. Patients who have received tumor immunotherapy (such as PD-1/L1, CTLA4, etc.) in the past 1 month, and inflammatory factor modulators such as Ulinastatin.
- •16. Patients who have received organ transplantation or surgery planning in the past 6 months.
- •17. Patients who cannot take food or drugs due to coma or intestinal obstruction.
- •18. Patients who have severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding, severe malnutrition, etc.
- •19. Women subjects that are pregnant or lactating, or subjects (including male subjects) having a
- •pregnancy plan (including plans for sperm donation or egg donation) during the study period.
- •20. Patients who have participated in any other clinical study within 2 weeks prior to randomization.
- •21. The investigators conclude that the patient is not suitable for the study.
研究者
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