CTRI/2021/04/032686尚未招募不适用
Effect of low- calorie sweetener - Sucralose (Sugar Free Natura) on cardio metabolic risk factors and Gut Microbiome among obese and adults with diabetes in India- A randomized trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Assessing the change in HbA1c with LCS- sucralose (pellet/powder/liquid form)
研究概览
简要总结
To our knowledge this study will be the first of its kind in India that will bring out evidence on the effect of low-calorie sweetener sucralose on body weight, waist circumference, fasting blood glucose, HbA1c, insulin resistance, lipid profile, inflammatory markers and gut microbiome both among adults with type 2 diabetes. The study findings could further provide clear public health message on the use of LCS -Sucralose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •.Adults with type 2 diabetes and BMI greater than 18.5 .Hba1c 8-12% .Individuals on stable OHA/insulin dose .Willing to follow study protocol .Willing to give informed consent .Willing to use LCS-sucralose for 12 weeks.
排除标准
- •.Any acute infections like viral fever, typhoid, cold, diarrhea, constipation last 1 month .Individuals with any disorders of liver, kidney, thyroid, or other endocrine diseases or other complications such as respiratory disorders, diabetes, cancer or heart attack and stroke that hinders the intervention .Individuals with any eating disorder .Participants undergoing any treatment or medications including antibiotics .Pregnant and lactating Women .Plans to relocate in the next 3 years.
- •.Planning longer duration of travel out of town.
结局指标
主要结局
Assessing the change in HbA1c with LCS- sucralose (pellet/powder/liquid form)
时间窗: 12 weeks
次要结局
- Assessing the effect of LCS-sucralose on body weight(Glycemic parameters ,Lipid profile,Inflammatory markers, Advanced glycation end products and)
研究者
研究点 (1)
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