Effect of Celery Seed on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-60
SponsorUniversity of Guadalajara

About this trial

The Metabolic Syndrome (MS) is a cluster of cardiometabolic risk factors, which include abdominal obesity, hyperglycemia, dyslipidemia, and high blood pressure. MS is a global health problem, it represents a risk factor for the progression of cardiovascular disease, which constitute the main cause of mortality in the world and in Mexico. The current treatment involves lifestyle changes and pharmacological treatment for each of the components of MS, however, there is no single approved treatment to control all components. Celery seed (Apium graveolens L.) from the Apiaceae family contains the flavonoids apigenin and luteolin; essential oils such as d-limonene, selinene and phthalides such as 3-n-butylphthalide. Thanks to its bioactive components, celery seed has proven to be effective in treating individual MS disorders; however, most studies are in animal models and there are no clinical studies that evaluate its effectiveness on all components of the system. MS, insulin sensitivity and insulin secretion so it could appear as a new, safe and effective complementary therapy for the treatment of MS.

The aim of this study is to evaluate the effect of celery seed on the components of metabolic syndrome, insulin sensitivity, and insulin secretion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients both sexes

Age between 30 and 60 years

Fasting glucose ≥ 100 mg/dL

Triglycerides ≥150 mg/dL

Disqualifiers

Pregnancy or breast-feeding

Glucose ≥126 mg/dL

Total cholesterol ≥240 mg/dL

Triglycerides ≥500mg/dL

Trial design

Design model

Parallel

Treatments tested in this trial

  • Celery Seed

    Drug

    Celery seed capsules (Apium graveolens L.) 150 mg twice times at day, one capsule with 75 mg before breakfast and one capsule with 75 mg before dinner during 12 weeks. Homologated to the other intervention. Oral administration.

  • Placebo

    Drug

    Placebo capsules (calcined magnesia) twice times at day, one capsule before breakfast and one capsule before dinner during 12 weeks. Homologated to the other intervention. Oral administration.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Celery seedExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Waist Circumference (WC)

Waist Circumference will be evaluated at baseline and week 12 by World Health Organization technique

Time frame
Baseline to week 12 (end of intervention)
2

Systolic Blood Pressure (SBP)

Systolic Blood Pressure (SBP) will be measured at baseline and week 12 with a digital sphygmomanometer three times in each arm to get an average

Time frame
Baseline to week 12 (end of intervention)
3

Diastolic Blood Pressure (DBP)

Diastolic Blood Pressure (DBP) will be measured at baseline and week 12 with a digital sphygmomanometer three times in each arm to get an average

Time frame
Baseline to week 12 (end of intervention)
4

High-Density Lipoprotein (HDL-c)

High density lipoprotein (HDL-c) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get c-HDL level

Time frame
Baseline to week 12 (end of intervention)

Secondary outcomes

1

Body weight

Body weight will be measured at baseline and week 12 with a bioimpedance analysis

Time frame
Baseline to week 12 (end of intervention)
2

Body Mass Index (BMI)

Body Mass Index (BMI) will be calculated at baseline and week 12 with the Quetelet index formula

Time frame
Baseline to week 12 (end of intervention)
3

Body Fat Percentage

Body fat percentage will be measured at baseline and week 12 with a bioimpedance analysis

Time frame
Baseline to week 12 (end of intervention)
4

Total Cholesterol (TC)

Total Cholesterol (TC) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get total cholesterol level

Time frame
Baseline to week 12 (end of intervention)

Other outcomes

Sponsors and contacts

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