Culinary Spices in Metabolic Syndrome.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-10

Study Completion Date

2016-11-13

Brief Summary

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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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Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

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Ginger

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

Group Type ACTIVE_COMPARATOR

Ginger

Intervention Type DIETARY_SUPPLEMENT

3g of dried powdered Ginger daily for 12 weeks

Cinnamon

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

Group Type ACTIVE_COMPARATOR

cinnamon

Intervention Type DIETARY_SUPPLEMENT

3g of dried powdered Cinnamon daily for 12 weeks.

Black Seed

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

Group Type ACTIVE_COMPARATOR

black seed

Intervention Type DIETARY_SUPPLEMENT

3g of dried powdered Black Seed daily for 12 weeks

Placebo

3g of powdered corn starch daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

3g of powdered corn starch daily for 12 weeks.

Interventions

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Ginger

3g of dried powdered Ginger daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

black seed

3g of dried powdered Black Seed daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

cinnamon

3g of dried powdered Cinnamon daily for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

3g of powdered corn starch daily for 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No