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

University of Guadalajara

Status: Not yet enrolling

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Fenugreek seed; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07056712

Fenugreek-MS

Details and patient eligibility

About

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.

Full description

A randomized, double-blind, placebo controlled clinical trial will be conducted in 28 patients with metabolic syndrome according to the criteria of the International Diabetes Federation. Patients will be assigned to two different arms: one group will receive fenugreek seed extract (1500 mg/day) or a matched placebo for 12 weeks.

At the beginning and end of the intervention, the following measurements will be taken: body weight, body mass index, waist circumference, body fat percentage, systolic blood pressure, diastolic blood pressure, glucose, triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein, insulin, creatinine, uric acid, alanine aminotransferase, and aspartate aminotransferase. In addition, insulin sensitivity and insulin secretion will be calculated. Written informed consent will be obtained from all volunteers.

Enrollment: 28 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women between 30 and 60 years old.
• Diagnosis of Metabolic Syndrome (MS) according to the International Diabetes Federation (IDF) criteria.

Waist circumference ≥90 cm in men and ≥80 cm in women, plus the presence of two or more of the following criteria:

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

• Systolic Blood Pressure ≥130 mmHg.

• Diastolic Blood Pressure ≥85 mmHg.

• Triglycerides ≥150 mg/dL.

• HDL cholesterol <40 mg/dL in men and <50 mg/dL in women.

  • Body Mass Index between 25.0 and 34.9 kg/m².
  • Stable weight during the 3 months prior to the start of the study (weight variation less than 10%).
  • Not receiving pharmacological treatment for any component of MS, insulin sensitivity, and/or insulin secretion.
  • Signed informed consent form.

Non-Inclusion Criteria:

• Suspected or confirmed pregnancy.
• Breastfeeding period.
• Fasting glucose ≥126 mg/dL.
• LDL cholesterol ≥155 mg/dL.
• Triglycerides ≥500 mg/dL.
• Systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg.
• Use of medications and/or supplements known to influence the study variables.
• History of kidney, thyroid, liver disease, or ischemic heart disease.
• Active smoker.
• Not using an effective and stable contraceptive method.

Exclusion criteria

• Voluntary withdrawal of informed consent.
• Treatment adherence ≤80%.
• Occurrence of a serious adverse event.
• Loss to follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

Fenugreek seed

Experimental group

Description:

500 mg of fenugreek seed before each meal for 12 weeks

Treatment:

Dietary Supplement: Fenugreek seed

Placebo

Placebo Comparator group

Description:

500 mg of calcined magnesia before each meal for 12 weeks

Treatment:

Other: Placebo