Clinical trial NCT06423248: Culinary Spices in Metabolic Syndrome.
Official title: The Effect of Therapeutic Doses of Culinary Spices in Metabolic Syndrome: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: United Arab Emirates University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in Fasting Blood Glucose at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
measure: Mean Change in HbA1c at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
Secondary outcomes:
measure: Mean Change in Blood Pressure at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
measure: Mean Change in Total Cholesterol at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
measure: Mean Change in LDL Cholesterol at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
measure: Mean Change in HDL Cholesterol at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
measure: Mean Change in Triglyceride concentrations at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
measure: Mean Change in Weight at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
measure: Mean Change in Body Mass Index at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
measure: Mean Change in Waist Circumference at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
measure: Mean Change in Waist to Hip ratio at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
measure: Mean Change in Densitometric Body Composition at 12 weeks
timeFrame: Baseline, Week 6 and Week 12
Other outcomes:
Locations:
city: Al Ain
country: United Arab Emirates
facility: United Arab Emirates University
state: Abu Dhabi
Study officials:
References: