The Effect of Therapeutic Doses of Culinary Spices in Metabolic Syndrome: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Mean Change in Fasting Blood Glucose at 12 weeks
研究概览
简要总结
This double blind, placebo controlled randomized controlled trial aims to evaluate the effect of three commonly used culinary spices - ginger (Zingiber officinale), cinnamon (Cinnamomum) and black seed (Nigella sativa) on the cardiometabolic parameters of individuals with risk factors of metabolic syndrome. Participants consume their assigned treatment for 12 weeks, and key cardiovascular and glucometabolic parameters are recorded at baseline, week 6, and week 12 of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Both patient and investigators were blind to treatment allocation, with an independent researcher providing the allocated treatments to the participants.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age (18-50 years)
- •2 or more of MetS diagnostic criteria:
- •high waist circumference (>80 cm for female and >94 cm for males),
- •elevated blood pressure (equal to or greater than 130/85 mm Hg or use of medication for hypertension),
- •high fasting blood glucose (equal to or greater than 100 mg/dL [5.6 mmol/L] or use of medication for hyperglycemia),
- •lowered HDL cholesterol (less than 40 mg/dL [1.03 mmol/L] for men and less than 50 mg/dL [1.29 mmol/L] for women) and
- •increased triglycerides (equal to or greater than 150 mg/dL [1.7 mmol/L]). Participants who had at least three risk factors out of five or had two risk factors and one borderline were included in the study.
- •Exclusion Criteria
- •older than 50 years old or younger than 17 years old and
- •did not meet the metabolic syndrome diagnostic criteria
- •allergic to spices
- •current smokers
- •pregnant women
- •lactating women or
- •currently taking medication and if they
- •refused to provide blood sample.
- •acute illnesses
- •chronic diseases such as kidney, liver, cardiovascular and gastrointestinal diseases were excluded from the study
排除标准
- 未提供
结局指标
主要结局
Mean Change in Fasting Blood Glucose at 12 weeks
时间窗: Baseline, Week 6 and Week 12
Fasting plasma glucose blood test taken at baseline, week 6 and week 12.
Mean Change in HbA1c at 12 weeks
时间窗: Baseline, Week 6 and Week 12
Glycated Haemoglobin blood test taken at baseline, week 6 and week 12.
次要结局
- Mean Change in Weight at 12 weeks(Baseline, Week 6 and Week 12)
- Mean Change in Body Mass Index at 12 weeks(Baseline, Week 6 and Week 12)
- Mean Change in Densitometric Body Composition at 12 weeks(Baseline, Week 6 and Week 12)
- Mean Change in Blood Pressure at 12 weeks(Baseline, Week 6 and Week 12)
- Mean Change in LDL Cholesterol at 12 weeks(Baseline, Week 6 and Week 12)
- Mean Change in Triglyceride concentrations at 12 weeks(Baseline, Week 6 and Week 12)
- Mean Change in Waist Circumference at 12 weeks(Baseline, Week 6 and Week 12)
- Mean Change in Waist to Hip ratio at 12 weeks(Baseline, Week 6 and Week 12)
- Mean Change in Total Cholesterol at 12 weeks(Baseline, Week 6 and Week 12)
- Mean Change in HDL Cholesterol at 12 weeks(Baseline, Week 6 and Week 12)
研究者
Ayesha Salem Al Dhaheri
Professor, Associate Provost, Student Affairs
United Arab Emirates University