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

Official title

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

Overview

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.

Detailed 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.

Interventions

• Dietary supplement Fenugreek seed
  Fenugreek seed: 1500 mg per day for 12 weeks
• Other Placebo
  Placebo: Calcined magnesia 1500 mg per day for 12 weeks

Primary outcome measures

• Waist Circumference (WC) [Time frame: Baseline to week 12 (end of intervention)]
• Systolic Blood Pressure (SBP) [Time frame: Baseline to week 12 (end of intervention)]
• Diastolic Blood Pressure (DBP) [Time frame: Baseline to week 12 (end of intervention)]
• High Density Lipoprotein Cholesterol (HDL-c) [Time frame: Baseline to week 12 (end of intervention)]
• Triglycerides (TG) [Time frame: Baseline to week 12 (end of intervention)]
• Fasting Plasma Glucose (FPG) [Time frame: Baseline to week 12 (end of intervention)]
• Insulin Sensitivity (IS) [Time frame: Baseline to week 12 (end of intervention)]
• Total Insulin Secretion (TIS) [Time frame: Baseline to week 12 (end of intervention)]
• First Phase of Insulin Secretion (FPIS) [Time frame: Baseline to week 12 (end of intervention)]

Secondary outcome measures (11)

• Body Weight (BW) [Time frame: Baseline to week 12 (end of intervention)]
• Body Mass Index (BMI) [Time frame: Baseline to week 12 (end of intervention)]
• Body Fat Percentage (BF%) [Time frame: Baseline to week 12 (end of intervention)]
• Total Cholesterol (TC) [Time frame: Baseline to week 12 (end of intervention)]
• Low Density Lipoprotein Cholesterol (LDL-c) [Time frame: Baseline to week 12 (end of intervention)]
• Very Low Density Lipoprotein (VLDL) [Time frame: Baseline to week 12 (end of intervention)]
• Aspartate Aminotransferase (AST) [Time frame: Baseline to week 12 (end of intervention)]
• Alanine Aminotransferase (ALT) [Time frame: Baseline to week 12 (end of intervention)]
• Creatinine [Time frame: Baseline to week 12 (end of intervention)]
• Uric Acid (UA) [Time frame: Baseline to week 12 (end of intervention)]
• Adverse Events (AE) [Time frame: Baseline to week 12 (end of intervention)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Mexico · 1 center

• Instituto de Terapéutica Experimental y Clínica (INTEC), Centro Universitario de Ciencias — Guadalajara

Identifiers

NCT: NCT07056712 · Fenugreek-MS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗