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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Fenugreek seed
  Fenugreek seed: 1500 mg per day for 12 weeks
• Другое Placebo
  Placebo: Calcined magnesia 1500 mg per day for 12 weeks

Первичные конечные точки

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

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

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

Идентификаторы

NCT: NCT07056712 · Fenugreek-MS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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