CTRI/2023/10/058380进行中（未招募）2 期
A double blind, randomized, crossover, placebo-controlled study to determine effect of GlucoSEB on postprandial glucose level. - NI
Advanced Enzymes Technologies Ltd.0 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
- •Subjects will be included in the study if they meet all of the following criteria:
- •1. Age =30 years, and of any gender.
- •2. Subjects with limited physical activity
- •3. BMI: 25 to 40 Kg/m2
- •4. Subjects who consume diet rich in carbohydrates ( >60%)
- •5. Subjects taking stable medicine dose for past 3 months
- •6. For prediabetic group, subjects with fasting blood sugar level (100-125 mg/dL) and HbA1c: 5.7 to 6.4%
- •7. For diabetic group, subjects with fasting blood sugar level (= 130 mg/dL) and HbA1c: 7.0 to 9.5%
- •8. For diabetic group, subjects who are consuming biguanides (Metformin), sulfonylurea, SGLT-2 inhibitors, thiazolidinediones for blood glucose control.
- •9. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
排除标准
- •Subjects will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:
- •1. Pregnant and lactating female.
- •2. Subjects with BMI = 40
- •3. Type I diabetic patients
- •4. For prediabetic group, subjects who are taking any sugar control supplements.
- •5. For diabetic group, subjects who are under the DPP-4 inhibitor, incretin mimetic, glucosidase inhibitor, rapid acting/short acting/ intermediate acting and premixed insulin-based treatment.
- •6. Subject with major chronic complications (including but not limited to) autoimmune disease, inflammation, etc.
- •7. Organic insufficiency (cardiac, hepatic, renal, respiratory)
- •8. Use of food supplements specifically containing fibers or polysaccharides
- •9. Chronic smoking and alcohol intake
- •10. Allergy to the ingredients in the test product.
- •11. History of any surgery in the past 3 months.
- •12. Subject currently taking or has in the past 30 days used GI related probiotics/prebiotics or any enzymes [prescription or over the counter (OTC)].
研究者
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