Study the impact of pearl millet consumption on lipid profile and body weight
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To study the impact of Pearl Millet consumption on body weight and lipid profile among Obese individuals with Dyslipidemia
研究概览
简要总结
It is a prospective,open label, randomised parallel group ,active controlled trial to study the impact of Pearl Millet consumption on body weight and lipid profile among Obese individuals with Dyslipidemia. Patients aged ≥ 18years, BMI ≥ 25kg/m2 with dyslipidemia is included in the study after exclusion criteria. After that, patients will be randomized using computer generated block method into 2 groups-intervention and control. Objective is to study the impact of Pearl Millet consumption on body weight and lipid profile among Obese individuals with Dyslipidemia after 12 weeks of intervention. Secondary objective is to assess the effect of pearl millet consumption on glycemic parameters, including fasting and postprandial blood glucose and HbA1c levels, as well as on insulin resistance (HOMA-IR and HOMA-B) in obese patients. Intervention group will be introduced with pearl millet based diet along with standard of care and control group with standard of care. Patients will be assessed with investigations at baseline and after 12 weeks and follow up will be done through phone call and physically. Statistical analysis will be done to compare the results in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Bmi more than or equal to 25kg/m2 Dyslipidemia-Any one of the following without indication of lipid lowering drug Triglyceride more than or equal to 150mg/dl HDL cholesterol less than 40 in men, less than 50 in women Total Cholesterol more than or equal to 200mg/dl LDL more than or equal to 100mg/dl Individuals not planning for nay pharmacotherapy and bariatric surgery for obesity in next 3 month.
排除标准
- •Type 2 Diabetes Mellitus (FBS more than or equal to 126mg/dL,PPBS more than or equal to 200mg/dL ,HbA1c more than or equal to 6.5%) On medication for Obesity/Dyslipidaemia Already on Millet based diet plan in past 3 months On medication which affect the lipid profile and body weight (statins,ART,antiepileptics/psychotics,OHA,beta blockers,VitA analogues.) Chronic heavy alcohol user(consuming 40-80g/day for men,20-40g/day for women) and patient with known psychiatric illnesses(eating disorder) Acute or chronic heart failure, CKD (Stage 3 or more), CLD (Child class B or C), Acute and chronic infections eg HIV, tuberculosis, chronic Hep C and Hep B Known active malignancies.
结局指标
主要结局
To study the impact of Pearl Millet consumption on body weight and lipid profile among Obese individuals with Dyslipidemia
时间窗: Shall be assessed at baseline and after 12 weeks
次要结局
- To assess the effect of pearl millet consumption on glycemic parameters, including fasting and postprandial blood glucose and HbA1c levels, as well as on insulin resistance (HOMA-IR and HOMA-B) in obese patients(Shall be assessed at baseline and after 12 weeks)
研究者
Dr.Dinesh V
All India Institute of Medical Sciences NEW DELHI