Culinary Spices in Metabolic Syndrome.

Metabolic Syndrome Clinical Trial

Official title:

The Effect of Therapeutic Doses of Culinary Spices in Metabolic Syndrome: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06423248
• Other study ID #: Protocol Number: 15/22
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

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