Metabolic SyndromeFenobetNCT06114134
The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome
A study testing Fenobet in people with Metabolic Syndrome and Complementary Therapies, run by Tehran University of Medical Sciences.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Metabolic Syndrome, Complementary Therapies, Diabetes Mellitus, Type 2
- What is being tested?
- Fenobet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People with metabolic syndrome
- Fasting sugar above 100 mg/dL
- Both men and women
- Age range 20-60 years
Who cannot join
- 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
About this study
Official title: 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.
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.
Read the detailed description
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.
- Being tested
- Fenobet, Placebo
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenobetDietary supplement
receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals)
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Fenobet |
| 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood sugar (FBS)
Fasting blood sugar in mg/dL will be reported
Measured: baseline and 2 months
Hemoglobin A1C (HbA1C)
HbA1C will be reported in percentage
Measured: baseline and 2 months
Secondary outcomes (8)
Lipid profile
Total Cholesterol
Measured: baseline and 2 months
Lipid profile
Triglyceride
Measured: baseline and 2 months
Lipid profile
High-density Cholesterol (HDL-C)
Measured: baseline and 2 months
Lipid profile
Low-Density Cholesterol (LDL-C)
Measured: baseline and 2 months
Antropometric Indices
Weight
Measured: baseline and 2 months
Antropometric Indices
Body Mass Index
Measured: baseline and 2 months
Antropometric Indices
Waist Circumference
Measured: baseline and 2 months
Antropometric Indices
Hip Circumference
Measured: baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Namazi, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114134
- Sponsor's protocol ID
- 97-1151
- Acronym
- Fenobet
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06114134
- Acronym / sponsor ID
- Fenobet / 97-1151
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenugreek extract | Experimental | Dietary Supplement: FenobetParticipants 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 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- People with metabolic syndrome
- Fasting sugar above 100 mg/dL
- Both men and women
- Age range 20-60 years
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenobetreceiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals) | Dietary supplement | Fenugreek extract |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Fasting blood sugar (FBS)
Time frame: baseline and 2 months
Fasting blood sugar in mg/dL will be reported
Hemoglobin A1C (HbA1C)
Time frame: baseline and 2 months
HbA1C will be reported in percentage
8 secondary outcomes
Lipid profile
Time frame: baseline and 2 months
Lipid profile
Time frame: baseline and 2 months
Lipid profile
Time frame: baseline and 2 months
Lipid profile
Time frame: baseline and 2 months
Antropometric Indices
Time frame: baseline and 2 months
Antropometric Indices
Time frame: baseline and 2 months
Antropometric Indices
Time frame: baseline and 2 months
Antropometric Indices
Time frame: baseline and 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fenobet in people with Metabolic Syndrome and Complementary Therapies, run by Tehran University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood sugar (FBS) (time frame: baseline and 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.