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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06423248
Other study ID # Protocol Number: 15/22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2015
Est. completion date November 13, 2016

Study information

Verified date May 2024
Source United Arab Emirates University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date November 13, 2016
Est. primary completion date November 13, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - age (18-50 years) and had 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: - did not meet the following inclusion criteria, older than 50 years old or younger than 17 years old and did not meet the metabolic syndrome diagnostic criteria. Additionally, participants were excluded if they are allergic to spices, current smokers, pregnant women, lactating women or currently taking medication and if they refused to provide blood sample. Also, participants with any acute illnesses or any chronic diseases such as kidney, liver, cardiovascular and gastrointestinal diseases were excluded from the study

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Culinary spices
Powdered culinary spices

Locations

Country Name City State
United Arab Emirates United Arab Emirates University Al Ain Abu Dhabi

Sponsors (1)

Lead Sponsor Collaborator
United Arab Emirates University

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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
Secondary Mean Change in Total Cholesterol at 12 weeks Total Cholesterol Blood Test taken at baseline, week 6 and week 12. Baseline, Week 6 and Week 12
Secondary 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
Secondary 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
Secondary 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
Secondary Mean Change in Weight at 12 weeks Weight taken at baseline, week 6 and week 12. Baseline, Week 6 and Week 12
Secondary 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
Secondary Mean Change in Waist Circumference at 12 weeks Waist Circumference taken at baseline, week 6 and week 12. Baseline, Week 6 and Week 12
Secondary 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
Secondary 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
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