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临床试验/CTRI/2024/09/074003
CTRI/2024/09/074003已完成不适用

Effect Of Palmyra Sprout Supplementation On The Fasting Blood Glucose Levels Of Prediabetic Subjects

Abinaya Devi K1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Reduced fasting blood sugar levels in the intervention group

研究概览

简要总结

Need For Study:-The global burden of prediabetes is substantial and growing. Enhancing prediabetes surveillance is necessary to effectively implement diabetes prevention policies and interventions. Hence, researching the effects of forgotten traditional plants like palmyra sprout to prevent diabetes can provide insights into the possibility of safer, more accessible, affordable and culturally relevant treatment options for populations worldwide.-There are very limited in vitro studies that exist on the anti-diabetic effect of palmyra sprout and most of it concludes quoting that in vivo studies are required for the same.-This research can also bridge the gap between traditional practices and modern scientific understanding. Protocol:The Study aims to assess and evaluate the effects of Palmyra Sprout in fasting blood glucose levels of Prediabetic individuals at risk of developing Type 2 Diabetes Mellitus.The study will begin with developing and analysing the nutritional composition of Palmyra Sprout supplement. This supplement powder will be provided to 12 prediabteic subjects in Intervention group after obtaining their consent for 30 days. The supplement can be consumed by the participants by mixing either with milk or water (their choice). Approx. dosage – 25grams/ day (based on reference article). No toxicity reported as per earlier studies. The Intervention group subjects fasting blood glucose levels before and after supplementing them with palmyra sprout powder will be assessed. Meanwhile, a group of 12 prediabetic subjects in Control group will not be provided with any supplement but only their fasting blood glucose level will be assessed two times with an interval of 30 days in between.The results between the Experimental group and Control group will be compared and appropriate statistical methods will be used to conclude the study.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Individuals with Fasting blood sugar levels between 100 to 125 mg/dL, Postprandial blood sugar levels between 140 to 199 mg/dL or HbA1C levels between 5.7% to 6.4% will be included in the study.
  • Willingness to comply with study procedures and follow-up visits.
  • Ability to provide informed consent.

排除标准

  • Individuals with any other disease conditions will be excluded from the study.
  • Vulnerable population (below 18 years of age, Pregnant women, Breastfeeding women) are excluded.
  • Non-willing participants will be exempted.
  • Current use of any antidiabetic medication or supplements -Participation in another clinical trial within the last 30 days.

结局指标

主要结局

Reduced fasting blood sugar levels in the intervention group

时间窗: 30 days

次要结局

未报告次要终点

研究者

发起方
Abinaya Devi K
申办方类型
Other [Self-Funded Project]
责任方
Principal Investigator
主要研究者

Abinaya Devi K

Sri Ramachandra Institute of Higher Education and Research

研究点 (1)

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