Culinary Spices in Metabolic Syndrome.

March 25, 2025 updated by: Ayesha Salem Al Dhaheri, United Arab Emirates University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in Fasting Blood Glucose at 12 weeks
Time Frame: Baseline, Week 6 and Week 12
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
Time Frame: Baseline, Week 6 and Week 12
Glycated Haemoglobin blood test taken at baseline, week 6 and week 12.
Baseline, Week 6 and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in Blood Pressure at 12 weeks
Time Frame: Baseline, Week 6 and Week 12
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
Time Frame: Baseline, Week 6 and Week 12
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
Time Frame: Baseline, Week 6 and Week 12
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
Time Frame: Baseline, Week 6 and Week 12
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
Time Frame: Baseline, Week 6 and Week 12
Triglyceride Blood Test taken at baseline, week 6 and week 12.
Baseline, Week 6 and Week 12
Mean Change in Weight at 12 weeks
Time Frame: Baseline, Week 6 and Week 12
Weight taken at baseline, week 6 and week 12.
Baseline, Week 6 and Week 12
Mean Change in Body Mass Index at 12 weeks
Time Frame: Baseline, Week 6 and Week 12
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
Time Frame: Baseline, Week 6 and Week 12
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
Time Frame: Baseline, Week 6 and Week 12
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
Time Frame: 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.
Baseline, Week 6 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
United Arab Emirates University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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