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Effect of Fenugreek Seed Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion

ConditionMetabolic Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorUniversity of Guadalajara

About this trial

Fenugreek has been shown to have beneficial effects on various metabolic abnormalities associated with metabolic syndrome (MS). However, no clinical trials have evaluated its effect on all components of MS, insulin sensitivity, and insulin secretion. Therefore, the main objective of this study is to assess the effect of fenugreek seed administration versus placebo on the components of metabolic syndrome, insulin sensitivity, and insulin secretion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women between 30 and 60 years old.

Diagnosis of Metabolic Syndrome (MS) according to the International Diabetes Federation (IDF) criteria.

Fasting glucose ≥100 mg/dL or previous diagnosis of type 2 diabetes.

Systolic Blood Pressure ≥130 mmHg.

Disqualifiers

Voluntary withdrawal of informed consent.

Treatment adherence ≤80%.

Occurrence of a serious adverse event.

Loss to follow-up.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fenugreek seed

    Dietary supplement

    Fenugreek seed: 1500 mg per day for 12 weeks

  • Placebo

    Other intervention

    Placebo: Calcined magnesia 1500 mg per day for 12 weeks

Treatment groups

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

Trial outcomes

Primary outcomes

1

Waist Circumference (WC)

Waist Circumference (WC) is evaluated at baseline and after 12 weeks with a flexible tape in the midpoint between the lowest rib and the iliac crest

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

Systolic Blood Pressure (SBP)

Systolic Blood Pressure (SBP) is measured at baseline and after 12 weeks with a digital sphygmomanometer

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

Diastolic Blood Pressure (DBP)

Diastolic Blood Pressure (DBP) is measured at baseline and after 12 weeks with a digital sphygmomanometer

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

High Density Lipoprotein Cholesterol (HDL-c)

High Density Lipoprotein Cholestero (HDL-c) is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques

Time frame
Baseline to week 12 (end of intervention)

Secondary outcomes

1

Body Weight (BW)

Body Weight (BW) is evaluated at baseline and after 12 weeks with an inbody 270

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

Body Mass Index (BMI)

Body Mass Index (BMI) is calculated at baseline and after 12 weeks with the Quetelet index formula

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

Body Fat Percentage (BF%)

Body Fat Percentage (BF%) 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) is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques

Time frame
Baseline to week 12 (end of intervention)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Guadalajara

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: