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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginger | Active Comparator | 3g of dried powdered Ginger (Zingiber officinale) daily for 12 weeks. |
|
| Cinnamon | Active Comparator | 3g of dried powdered Cinnamon (Cinnamomum) daily for 12 weeks. |
|
| Black Seed | Active Comparator | 3g of dried powdered Black Seed (Nigella sativa) daily for 12 weeks. |
|
| Placebo | Placebo Comparator | 3g of powdered corn starch daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginger | Dietary Supplement | 3g of dried powdered Ginger daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Fasting Blood Glucose at 12 weeks | Fasting plasma glucose blood test taken at baseline, week 6 and week 12. | Baseline, Week 6 and Week 12 |
| Mean Change in HbA1c at 12 weeks | Glycated Haemoglobin blood test taken at baseline, week 6 and week 12. | Baseline, Week 6 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Blood Pressure at 12 weeks | Systolic and diastolic blood pressure taken at baseline, week 6 and week 12. | Baseline, Week 6 and Week 12 |
| Mean Change in Total Cholesterol at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Arab Emirates University | Al Ain City | Abu Dhabi Emirate | United Arab Emirates |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000713927 | ginger extract |
| C000723271 | Nigella sativa oil |
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Both patient and investigators were blind to treatment allocation, with an independent researcher providing the allocated treatments to the participants.
| black seed |
| Dietary Supplement |
3g of dried powdered Black Seed daily for 12 weeks |
|
| cinnamon | Dietary Supplement | 3g of dried powdered Cinnamon daily for 12 weeks. |
|
| Placebo | Other | 3g of powdered corn starch daily for 12 weeks. |
|
Total Cholesterol Blood Test taken at baseline, week 6 and week 12.
| Baseline, Week 6 and Week 12 |
| Mean Change in LDL Cholesterol at 12 weeks | Low Density Lipoprotein Blood Test taken at baseline, week 6 and week 12. | Baseline, Week 6 and Week 12 |
| Mean Change in HDL Cholesterol at 12 weeks | High Density Lipoprotein Blood Test taken at baseline, week 6 and week 12. | Baseline, Week 6 and Week 12 |
| Mean Change in Triglyceride concentrations at 12 weeks | Triglyceride Blood Test taken at baseline, week 6 and week 12. | Baseline, Week 6 and Week 12 |
| Mean Change in Weight at 12 weeks | Weight taken at baseline, week 6 and week 12. | Baseline, Week 6 and Week 12 |
| Mean Change in Body Mass Index at 12 weeks | Weight taken at baseline, week 6 and week 12, and BMI calculated as weight divided by height squared. | Baseline, Week 6 and Week 12 |
| Mean Change in Waist Circumference at 12 weeks | Waist Circumference taken at baseline, week 6 and week 12. | Baseline, Week 6 and Week 12 |
| Mean Change in Waist to Hip ratio at 12 weeks | Waist and Hip Circumference taken at baseline, week 6 and week 12, and Waist-Hip ratio calculated. | Baseline, Week 6 and Week 12 |
| Mean Change in Densitometric Body Composition at 12 weeks | Dual Energy Xray Absorptiometry performed at baseline, week 6 and week 12, and Fat mass, body fat percentage, visceral fat, fat free mass, and skeletal muscle mass calculated. | Baseline, Week 6 and Week 12 |
| D009750 |
| Nutritional and Metabolic Diseases |