CTRI/2021/02/030921尚未招募Unknown
“An Open label , two arms active controlled and randomized , Clinical Study to Evaluate the Efficacy and Safety of Sugarlite, A Unique Sugar Blended Formulation in Normal to Mild overweight subjects.â€
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Weight , BMI , Blood glucose and Lipid Parameters
研究概览
简要总结
This is a non DCGI appoved trial for sugar substitute already marketed in India under food guidlelines and to know whetrher this is better than sugar in certain parameters. The Primary goals are to see body weight, Hip girth, waist girth , Hip to Waist ratio , RBS and HBA 1c values while Lipid profile and Liver function tests and blood parameters are for secondary endpoints and safety analysis of this sugar substitute
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Subjects of both sexes in the age group of
- •45 years •Normal to Pre obese subjects (BMI – 23.00kg/M2 to 26 kg/M2) •Subjects willing to give written informed consent. •Those who agree to follow the general guidelines on diet, sugar intake and exercise. •Subjects who have not participated in similar kind of study in last 4 weeks.
排除标准
- •â€¢Subjects with established hypertension, renal, hepatic or cardiac failure •Endocrine disorders like Hypothyroid ( if already on treatment) •Subjects with Dyslipidemia or Inborn errors of Fat metabolism.
- •â€¢Subjects with Postprandial sugars above 150 mg /dl in two tests so can be labelled Early Diabetic •History of drug hyper sensitivity or allergic condition that might interfere with the study •Use of drugs or dietary supplements that might influence body weight, body fat, or serum lipid levels like Anti diabetic drugs like Metformin and Statins.
- •â€¢Pregnant & lactating women.
- •â€¢Not willing to sign informed consent form.
结局指标
主要结局
Weight , BMI , Blood glucose and Lipid Parameters
时间窗: Baseline , 30 days , 60 days and 90 days
次要结局
- Blood cholesterol , Trigycerides, random bllod sugar and Hba1 C values(Once every month for 3 months after baseline values)
研究者
研究点 (1)
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