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临床试验/NCT06114134
NCT06114134Unknown不适用

The Effect of Fenobet® Capsules (Fenugreek Seed Extract) on Glycemic Status, Lipid Pattern and Anthropometric Indices in People With Metabolic Syndrome: a Randomized, Double-blind, Controlled Clinical Trial.

Tehran University of Medical Sciences0 个研究点目标入组 60 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
Hemoglobin A1C (HbA1C)

研究概览

简要总结

The current study is a three-blind, randomized clinical trial study that will be conducted on 60 people with metabolic syndrome. The eligible participants were allocated randomly to one of the two study groups (Fenobet, Placebo). Then, the eligible people were in one of two groups 1) receiving fenugreek extract, 2), receiving placebos and were examined for 8 weeks. At baseline and after two months of intervention, biochemical parameters, and anthropometric indices will be measured.

详细描述

The current study is a three-blind, randomized clinical trial study that will be conducted on 60 people with metabolic syndrome. According to the ATP criteria, a person who has at least 3 of the following 5 components was considered as metabolic syndrome.

After providing the necessary information about the study to patients, written informed consent will be obtained from eligible volunteers.

Inclusion criteria:

  • People with metabolic syndrome
  • Fasting sugar above 100 mg/dL
  • Both men and women
  • Age range 20-60 years Exclusion criteria
  • Injection of insulin or liraglutide
  • People under 20 years old and over 60 years old
  • having chronic cardiovascular diseases, chronic liver and kidney diseases, uncontrolled thyroid disorders and malignancies including cancer
  • Taking herbal medicines or herbs to control blood sugar and fat in the last 6 months
  • Patients who are treated with a special diet such as vegetarianism or a special exercise program.
  • Allergy
  • Pregnant and lactating women The participants were allocated randomly to one of the two study groups (Fenobet, Placebo) by a random number table. Then, the eligible people were in one of two groups 1) receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals), 2), receiving placebos (3 capsules of 500 mg, 1 capsule half an hour before meals) and were examined for 8 weeks. It is worth noting that the participants were asked not to change their physical activity and diet during the study and to report any changes in the type and dosage of the drug to the researchers. The capsule and container intended for the placebo will be exactly the same size and color as the fenugreek capsule and a dark container will be chosen for the capsules. At baseline and after two months of intervention, biochemical parameters (fasting blood sugar, HbA1C, lipid profile, C-reactive protein), and anthropometric indices (weight, body mass index, waist circumference, Hip circumference) will be measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •People with metabolic syndrome
  • •Fasting sugar above 100 mg/dL
  • •Both men and women
  • •Age range 20-60 years

排除标准

  • •Injection of insulin or liraglutide
  • •People under 20 years old and over 60 years old
  • •having chronic cardiovascular diseases, chronic liver and kidney diseases, uncontrolled thyroid disorders and malignancies including cancer
  • •Taking herbal medicines or herbs to control blood sugar and fat in the last 6 months
  • •Patients who are treated with a special diet such as vegetarianism or a special exercise program.
  • •Pregnant and lactating women

研究组 & 干预措施

Fenugreek extract

Experimental

Participants in this group will receive fenugreek extract capsules (500 mg/day, three times a day, 30 minutes before each main meal) along with common treatments

干预措施: Fenobet (Dietary Supplement)

Placebo

Placebo Comparator

Participants in this group will receive starch with added color (similar to the color of fenugreek extract) capsules (with the same size and color of fenugreek) (500 mg/day, three times a day, 30 minutes before each main meal) along with common treatments

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Hemoglobin A1C (HbA1C)

时间窗: baseline and 2 months

HbA1C will be reported in percentage

Fasting blood sugar (FBS)

时间窗: baseline and 2 months

Fasting blood sugar in mg/dL will be reported

次要结局

  • Lipid profile(baseline and 2 months)
  • Antropometric Indices(baseline and 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazli Namazi

Assistant Professor

Tehran University of Medical Sciences

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