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Completed

NCT Number: NCT06423248

Culinary Spices in Metabolic Syndrome.

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United Arab Emirates University

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginger

Dietary Supplement

3g of dried powdered Ginger daily for 12 weeks

black seed

Dietary Supplement

3g of dried powdered Black Seed daily for 12 weeks

Cinnamon

Dietary Supplement

3g of dried powdered Cinnamon daily for 12 weeks.

Placebo

Other

3g of powdered corn starch daily for 12 weeks.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Mean Change in Weight at 12 weeks

    Time frame: Baseline, Week 6 and Week 12

    Weight taken at baseline, week 6 and week 12.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

United Arab Emirates University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 21, 2024
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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