Metabolic Syndrome
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTGinger
3g of dried powdered Ginger daily for 12 weeks
DIETARY_SUPPLEMENTblack seed
3g of dried powdered Black Seed daily for 12 weeks
DIETARY_SUPPLEMENTcinnamon
3g of dried powdered Cinnamon daily for 12 weeks.
OTHERPlacebo
3g of powdered corn starch daily for 12 weeks.
Sponsors
United Arab Emirates University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Both patient and investigators were blind to treatment allocation, with an independent researcher providing the allocated treatments to the participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Fasting Blood Glucose at 12 weeks | 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 | Baseline, Week 6 and Week 12 | Glycated Haemoglobin blood test taken at baseline, week 6 and week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in LDL Cholesterol at 12 weeks | Baseline, Week 6 and Week 12 | Low Density Lipoprotein Blood Test taken at baseline, week 6 and week 12. |
| Mean Change in HDL Cholesterol at 12 weeks | Baseline, Week 6 and Week 12 | High Density Lipoprotein Blood Test taken at baseline, week 6 and week 12. |
| Mean Change in Triglyceride concentrations at 12 weeks | Baseline, Week 6 and Week 12 | Triglyceride Blood Test taken at baseline, week 6 and week 12. |
| Mean Change in Weight at 12 weeks | Baseline, Week 6 and Week 12 | Weight taken at baseline, week 6 and week 12. |
| Mean Change in Blood Pressure at 12 weeks | Baseline, Week 6 and Week 12 | Systolic and diastolic blood pressure taken at baseline, week 6 and week 12. |
| Mean Change in Waist Circumference at 12 weeks | Baseline, Week 6 and Week 12 | Waist Circumference taken at baseline, week 6 and week 12. |
| Mean Change in Waist to Hip ratio at 12 weeks | Baseline, Week 6 and Week 12 | Waist and Hip Circumference taken at baseline, week 6 and week 12, and Waist-Hip ratio calculated. |
| Mean Change in Densitometric Body Composition at 12 weeks | Baseline, Week 6 and Week 12 | 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. |
| Mean Change in Body Mass Index at 12 weeks | Baseline, Week 6 and Week 12 | Weight taken at baseline, week 6 and week 12, and BMI calculated as weight divided by height squared. |
| Mean Change in Total Cholesterol at 12 weeks | Baseline, Week 6 and Week 12 | Total Cholesterol Blood Test taken at baseline, week 6 and week 12. |
Countries
United Arab Emirates
Outcome results
None listed