## Protocol Section
### Identification Module
**NCT ID:** NCT06423248

**Brief Title:** Culinary Spices in Metabolic Syndrome.

**Official Title:** The Effect of Therapeutic Doses of Culinary Spices in Metabolic Syndrome: A Randomized Controlled Trial.

#### Organization Study ID Info
**ID:** Protocol Number: 15/22
#### Organization
**Class:** OTHER
**Full Name:** United Arab Emirates University
### Status Module
#### Completion Date
**Date:** 2016-11-13

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-11-13

**Type:** ACTUAL

#### Start Date
**Date:** 2015-05-10

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** United Arab Emirates University

#### Responsible Party

**Investigator Affiliation:** United Arab Emirates University

**Investigator Full Name:** Ayesha Salem Al Dhaheri

**Investigator Title:** Professor, Associate Provost, Student Affairs

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Metabolic Syndrome

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** Both patient and investigators were blind to treatment allocation, with an independent researcher providing the allocated treatments to the participants.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants consumed 3g of dried powdered Ginger (Zingiber officinale) daily for 12 weeks.

**Intervention Names:**

- Dietary Supplement: Culinary spices

**Label:** Ginger

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Participants consumed 3g of dried powdered Cinnamon (Cinnamomum) daily for 12 weeks.

**Intervention Names:**

- Dietary Supplement: Culinary spices

**Label:** Cinnamon

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Participants consumed 3g of dried powdered Black Seed (Nigella sativa) daily for 12 weeks.

**Intervention Names:**

- Dietary Supplement: Culinary spices

**Label:** Black Seed

**Type:** ACTIVE_COMPARATOR

#### Arm Group 4

**Description:** Participants consumed 3g of powdered corn starch daily for 12 weeks.

**Intervention Names:**

- Dietary Supplement: Culinary spices

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Black Seed

- Cinnamon

- Ginger

- Placebo

**Description:** Powdered culinary spices

**Name:** Culinary spices

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Fasting plasma glucose blood test taken at baseline, week 6 and week 12.

**Measure:** Mean Change in Fasting Blood Glucose at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

**Description:** Glycated Haemoglobin blood test taken at baseline, week 6 and week 12.

**Measure:** Mean Change in HbA1c at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

#### Secondary Outcomes

**Description:** Systolic and diastolic blood pressure taken at baseline, week 6 and week 12.

**Measure:** Mean Change in Blood Pressure at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

**Description:** Total Cholesterol Blood Test taken at baseline, week 6 and week 12.

**Measure:** Mean Change in Total Cholesterol at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

**Description:** Low Density Lipoprotein Blood Test taken at baseline, week 6 and week 12.

**Measure:** Mean Change in LDL Cholesterol at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

**Description:** High Density Lipoprotein Blood Test taken at baseline, week 6 and week 12.

**Measure:** Mean Change in HDL Cholesterol at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

**Description:** Triglyceride Blood Test taken at baseline, week 6 and week 12.

**Measure:** Mean Change in Triglyceride concentrations at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

**Description:** Weight taken at baseline, week 6 and week 12.

**Measure:** Mean Change in Weight at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

**Description:** Weight taken at baseline, week 6 and week 12, and BMI calculated as weight divided by height squared.

**Measure:** Mean Change in Body Mass Index at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

**Description:** Waist Circumference taken at baseline, week 6 and week 12.

**Measure:** Mean Change in Waist Circumference at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

**Description:** Waist and Hip Circumference taken at baseline, week 6 and week 12, and Waist-Hip ratio calculated.

**Measure:** Mean Change in Waist to Hip ratio at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

**Description:** 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.

**Measure:** Mean Change in Densitometric Body Composition at 12 weeks

**Time Frame:** Baseline, Week 6 and Week 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* age (18-50 years) and had 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:

* did not meet the following inclusion criteria, older than 50 years old or younger than 17 years old and did not meet the metabolic syndrome diagnostic criteria. Additionally, participants were excluded if they are allergic to spices, current smokers, pregnant women, lactating women or currently taking medication and if they refused to provide blood sample. Also, participants with any acute illnesses or any chronic diseases such as kidney, liver, cardiovascular and gastrointestinal diseases were excluded from the study

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Al Ain

**Country:** United Arab Emirates

**Facility:** United Arab Emirates University

**State:** Abu Dhabi

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007333

- Term: Insulin Resistance

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M23005

- Name: Metabolic Syndrome

- Relevance: HIGH

- As Found: Metabolic Syndrome

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M10370

- Name: Insulin Resistance

- Relevance: LOW

- As Found: Unknown

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000024821

- Term: Metabolic Syndrome

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T238

- Name: Nigella

- Relevance: LOW

- As Found: Unknown

- ID: T166

- Name: Ginger

- Relevance: LOW

- As Found: Unknown

- ID: T115

- Name: Cinnamon

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
