Effect of the Lactovegetarian Diet and Intermittent Fasting on Metabolic Parameters and Quality of Life Among Type 2 Diabetic Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Fasting blood sugar, HbA1c
研究概览
简要总结
The present study " Effect of Lactovegetarian Diet and Intermittent Fasting on Metabolic Parameters and Quality of Life Among Type 2 Diabetic Women- A Randomized Prospective Controlled Study" aims to study the impact of Lactovegetarian Diet(combination of Plant-based and Diary products) and Intermittent Fasting (Time and Calorie Restricted) on Type 2 Diabetic Women. Diabetes is a chronic disease and increases the risk of complications associated with it. It has been that Dietary management plays an important role in controlling blood sugar levels and reducing the risk of complications.
The study is done at two major centers in Pune, India. These include SUHRC (Symbiosis University Hospital & Research Center) and SPHERE (Society of Prevention, Healthcare, Education and Research). The participants are randomized into two groups: One following the Lactovegetarian Diet and Another following the Standard Diabetic Diet as advised by ICMR. The intervention is given for 3 months, and regular follow-up will be conducted.
The study’s primary objective is to investigate the effect of the Lactovegetarian diet and Intermittent fasting on improving the glycemic and lipemic profile of Diabetic Women. The study also focuses on investigating the effect of intervention in the reduction of weight, BMI, and Blood pressure. It also sees the adherence of the participants to the intervention and improvement in their Quality of Life before and after the intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •The study includes the women population with or without hypertension with a minimum of 1 year of Diabetes.
- •The included participants must have an age between 25-60 years with HbA1c values 6.5-9.
- •Subjects taking any oral hypoglycemic agents are considered for the study.
排除标准
- •The study excludes Males and those who do not wish to disclose gender are excluded from the study.
- •Pregnant, Lactating women or with Gestational Diabetes Mellitus(GDM) are not considered for the study.
- •Any women with co-morbidities like PCOS/PCOD, thyroid, Cancer, HIV, CVD are excluded from the study.
结局指标
主要结局
Fasting blood sugar, HbA1c
时间窗: 12 weeks
次要结局
- Weight, BMI, lipid profile, Quality of life(24 week)
研究者
Anu Mahajan
Symbiosis International (Deemed) Univeristy