CTRI/2019/03/017953已完成Unknown
Multicentric, randomized, four arm, double blind, parallel group study in adult hyperlipidemic, Preâ€diabetic and Normotensive subjects.
Spectrum Clinical Research Pvt Ltd2 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2019年8月3日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- To evaluate the effect of treatment on LDL-C levels in comparison with all four groups.
研究概览
简要总结
| A multicentric, randomized, four arm, double blind, parallel group study to evaluate the efficacy of Blended edible vegetable oils (Test Blend 1 and Test Blend 2) in comparison with commonly consumed oils (Control) in Hyperlipidemic, Preâ€diabetic, Normotensive adult subjects. |
Subjects will be randomized to one of the four groups:
Group I – Consuming food prepared in Test Blend 1
Group II – Consuming food prepared in Palmolein oil (Control 1)
Group III – Consuming food prepared in commonly used oil (groundnut oil, sunflower oil, soyabean oil) (Control 2)
Group IV – Consuming food prepared in Test Blend 2
Subjects would be asked to accommodate their cooking oil consumption by 500 ml./person/month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •LDL Cholesterol levels 130-189mg/dl (ATP III Guidelines)
- •Patient with body mass index of ≥23 kg/m2 and ≤30 kg/m2
- •Untreated Dyslipidemia
- •Willingness to maintain current activity levels and follow the prescribed diet.
排除标准
- •Use of oral or injected corticosteroids or anabolic steroids 3 months prior/during the study
- •Uncontrolled thyroidism
- •Poorly controlled hypertension (resting blood pressure ≥140 mm Hg systolic and/or ≥90 mm Hg diastolic)
- •Participants on Medication/ alternative medicine/special diets for weight loss
- •Current smoker
- •Women who are pregnant, lactating, or planning to become pregnant
- •Liver disorders.
结局指标
主要结局
To evaluate the effect of treatment on LDL-C levels in comparison with all four groups.
时间窗: 90 days from Baseline Visit.
次要结局
- To evaluate the effect of treatment on following parameters such as TC, TG, HDL, VLDL, oxLDL, hsCRP, HbA1C, Fasting & PP sugar Systolic & Diastolic BP, Mean Arterial Pressure, BMI,Waist Circumference & quality of life.(90 days from Baseline Visit.)
研究者
研究点 (2)
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