NCT06423248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2016

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
Last Updated

March 30, 2025

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

May 15, 2024

Last Update Submit

March 25, 2025

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Mean Change in Blood Pressure at 12 weeks

    Baseline, Week 6 and Week 12

  • Mean Change in Total Cholesterol at 12 weeks

    Baseline, Week 6 and Week 12

  • Mean Change in LDL Cholesterol at 12 weeks

    Baseline, Week 6 and Week 12

  • Mean Change in HDL Cholesterol at 12 weeks

    Baseline, Week 6 and Week 12

  • Mean Change in Triglyceride concentrations at 12 weeks

    Baseline, Week 6 and Week 12

  • +5 more secondary outcomes

Study Arms (4)

Ginger

ACTIVE COMPARATOR

3g of dried powdered Ginger (Zingiber officinale) daily for 12 weeks.

Dietary Supplement: Ginger

Cinnamon

ACTIVE COMPARATOR

3g of dried powdered Cinnamon (Cinnamomum) daily for 12 weeks.

Dietary Supplement: cinnamon

Black Seed

ACTIVE COMPARATOR

3g of dried powdered Black Seed (Nigella sativa) daily for 12 weeks.

Dietary Supplement: black seed

Placebo

PLACEBO COMPARATOR

3g of powdered corn starch daily for 12 weeks.

Other: Placebo

Interventions

GingerDIETARY_SUPPLEMENT

3g of dried powdered Ginger daily for 12 weeks

Ginger
black seedDIETARY_SUPPLEMENT

3g of dried powdered Black Seed daily for 12 weeks

Black Seed
cinnamonDIETARY_SUPPLEMENT

3g of dried powdered Cinnamon daily for 12 weeks.

Cinnamon
PlaceboOTHER

3g of powdered corn starch daily for 12 weeks.

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age (18-50 years)
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Arab Emirates University

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

ginger extractNigella sativa oil

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Both patient and investigators were blind to treatment allocation, with an independent researcher providing the allocated treatments to the participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Associate Provost, Student Affairs

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 21, 2024

Study Start

May 10, 2015

Primary Completion

November 13, 2016

Study Completion

November 13, 2016

Last Updated

March 30, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

AE(1)