Culinary Spices in Metabolic Syndrome.

United Arab Emirates University

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: black seed; Dietary Supplement: cinnamon; Other: Placebo; Dietary Supplement: Ginger

Study type: Interventional

Funder types: Other

Identifiers

NCT06423248

Protocol Number: 15/22

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

Ginger

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Ginger

Cinnamon

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: cinnamon

Black Seed

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: black seed

Placebo

Placebo Comparator group

Description:

3g of powdered corn starch daily for 12 weeks.

Treatment:

Other: Placebo