Culinary Spices in Metabolic Syndrome.

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Ginger; Dietary supplement: cinnamon; Dietary supplement: black seed; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi
    • Al Ain, Abu Dhabi, United Arab Emirates
      • United Arab Emirates University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ginger; 3g of dried powdered Ginger (Zingiber officinale) daily for 12 weeks.	Dietary supplement: Ginger; 3g of dried powdered Ginger daily for 12 weeks
Active Comparator: Cinnamon; 3g of dried powdered Cinnamon (Cinnamomum) daily for 12 weeks.	Dietary supplement: cinnamon; 3g of dried powdered Cinnamon daily for 12 weeks.
Active Comparator: Black Seed; 3g of dried powdered Black Seed (Nigella sativa) daily for 12 weeks.	Dietary supplement: black seed; 3g of dried powdered Black Seed daily for 12 weeks
Placebo Comparator: Placebo; 3g of powdered corn starch daily for 12 weeks.	Other: Placebo; 3g of powdered corn starch daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: United Arab Emirates University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2015
• Primary Completion (Actual): November 13, 2016
• Study Completion (Actual): November 13, 2016

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: Protocol Number: 15/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No