Type 2 Diabetes Mellitus (T2DM)NCT07038577
Impact of Fenugreek Supplementation on Obesity and Hyperglycemia Among Diabetic Adults in Saudi Arabia
A study testing Fenugreek Seed Powder in people with Type 2 Diabetes Mellitus (T2DM) and Obesity and Type 2 Diabetes, run by University of Hail at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to learn if Fenugreek seed powder helps lower body weight and blood sugar in adults with type 2 diabetes who are overweight or obese. The main questions it aims to answer are: Does Fenugreek lower body mass index (BMI)? Does Fenugreek lower fasting blood sugar, random blood sugar… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Obesity and Type 2 Diabetes, Hyperglycemia
- What is being tested?
- Fenugreek Seed Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2025to 1 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Diagnosed with type 2 diabetes mellitus
- Body Mass Index (BMI) classified as overweight or obese
- Receiving standard diabetes treatment (e.g., oral hypoglycemic agents)
- Able and willing to provide informed consent
- Residing in Hail City, Saudi Arabia
Who cannot join
- Diagnosed with type 1 diabetes mellitus
- Currently using insulin therapy
- Pregnant or breastfeeding women
- Known allergy or sensitivity to Fenugreek
- Diagnosed gastrointestinal diseases or malabsorption conditions
- Participation in another clinical trial within the past 3 months
- Any serious medical or psychiatric condition that, in the opinion of the investigators, could interfere with study participation
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Fenugreek Supplementation on Obesity and Hyperglycemia Among Diabetic Adults in Saudi Arabia: A Quasi-Experimental Study
The goal of this clinical trial is to learn if Fenugreek seed powder helps lower body weight and blood sugar in adults with type 2 diabetes who are overweight or obese. The main questions it aims to answer are:
Does Fenugreek lower body mass index (BMI)? Does Fenugreek lower fasting blood sugar, random blood sugar, and HbA1c levels? Researchers will compare people who take Fenugreek along with their regular diabetes care to people who receive only standard diabetes care, to see if the Fenugreek supplement adds extra benefits.
Read more
Participants will:
Take 10 grams of Fenugreek seed powder twice a day (before breakfast and dinner) for 3 months.
Follow their usual diabetes treatment and a recommended meal plan. Visit the clinic four times during the study to check weight and blood sugar levels.
This study is being done in Hail City, Saudi Arabia.
Read the detailed description
This clinical trial tested whether Fenugreek seed powder, a natural dietary supplement, could help lower blood sugar and reduce body weight in adults with type 2 diabetes. The study was conducted in Hail City, Saudi Arabia, and involved 80 participants who were either overweight or obese and diagnosed with type 2 diabetes.
Participants were assigned to one of two groups:
The intervention group received 10 grams of Fenugreek seed powder twice daily (before breakfast and dinner) for three months, in addition to their usual diabetes treatment and a standard meal plan.
The control group received only their standard diabetes care and meal plan, without the Fenugreek supplement.
The study used a quasi-experimental pretest-posttest design. Participants' weight (BMI), fasting blood sugar (FBS), random blood sugar (RBS), and HbA1c were measured at the start and monitored throughout the three-month period. Data were collected from local clinics and hospitals that serve people with diabetes in the region.
This study aims to provide evidence on the potential role of Fenugreek as a safe, culturally accepted, and cost-effective supplement that can support diabetes management and reduce obesity-related complications in the Saudi population
- Being tested
- Fenugreek Seed Powder
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenugreek Seed PowderOther
Participants in the intervention group received 10 grams of ground Fenugreek seed powder, administered twice daily (before breakfast and dinner), for a total of 3 months. The Fenugreek powder was consumed mixed with water, in addition to the participants' regular antidiabetic medications and a standardized meal plan. The supplement was provided in a non-encapsulated, natural powdered form, and was not combined with any other herbal or pharmaceutical products.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Fenugreek Supplementation | Experimental | 40 Participants in this group received 10 grams of Fenugreek seed powder twice daily (before breakfast and dinner) for 3 months, in addition to their usual diabetes treatment and a standard meal plan. Receives: Other: Fenugreek Seed Powder |
| Arm 2: Standard Care Only | No intervention | 40 Participants in this group continued their usual diabetes treatment and followed a standard meal plan. They did not receive the Fenugreek supplement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI)
BMI will be calculated as weight in kilograms divided by the square of height in meters (kg/m²).
Measured: Baseline and 3 months after intervention
Secondary outcomes (3)
Change in Fasting Blood Sugar (FBS)
Fasting blood sugar will be measured in mg/dL to assess glycemic control
Measured: Baseline and 3 months after intervention
Change in Random Blood Sugar (RBS)
Random blood sugar will be measured in mg/dL to evaluate fluctuations in blood glucose levels.
Measured: Baseline and 3 months after intervention
Change in Hemoglobin A1c (HbA1c)
HbA1c will be measured as a percentage to assess long-term glycemic control.
Measured: Baseline and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jan 2025
- Primary completion1 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to one of two parallel groups. One group received Fenugreek seed powder along with standard diabetes treatment, while the other group received standard treatment only. Each participant remained in their assigned group for the full duration of the 3-month study period, with no crossover between groups.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bushra Alshammari, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038577
- Sponsor's protocol ID
- UOHail
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) with other researchers. The data collected will be used solely for the purposes outlined in the approved research protocol and will remain confidential. Any future data sharing (if considered) would require additional ethical clearance and participant consent.
Publications
Neelakantan N, Narayanan M, de Souza RJ, van Dam RM. Effect of fenugreek (Trigonella foenum-graecum L.) intake on glycemia: a meta-analysis of clinical trials. Nutr J. 2014 Jan 18;13:7. doi: 10.1186/1475-2891-13-7.
PubMed 24438170
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fenugreek Supplementation on Obesity and Hyperglycemia Among Diabetic Adults in Saudi Arabia: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07038577
- Acronym / sponsor ID
- UOHail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of HailUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 26 Jun 2025 (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 goal of this clinical trial is to learn if Fenugreek seed powder helps lower body weight and blood sugar in adults with type 2 diabetes who are overweight or obese. The main questions it aims to answer are:
Does Fenugreek lower body mass index (BMI)? Does Fenugreek lower fasting blood sugar, random blood sugar, and HbA1c levels? Researchers will compare people who take Fenugreek along with their regular diabetes care to people who receive only standard diabetes care, to see if the Fenugreek supplement adds extra benefits.
Participants will:
Take 10 grams of Fenugreek seed powder twice a day (before breakfast and dinner) for 3 months.
Follow their usual diabetes treatment and a recommended meal plan. Visit the clinic four times during the study to check weight and blood sugar levels.
This study is being done in Hail City, Saudi Arabia.
Detailed description
This clinical trial tested whether Fenugreek seed powder, a natural dietary supplement, could help lower blood sugar and reduce body weight in adults with type 2 diabetes. The study was conducted in Hail City, Saudi Arabia, and involved 80 participants who were either overweight or obese and diagnosed with type 2 diabetes.
Participants were assigned to one of two groups:
The intervention group received 10 grams of Fenugreek seed powder twice daily (before breakfast and dinner) for three months, in addition to their usual diabetes treatment and a standard meal plan.
The control group received only their standard diabetes care and meal plan, without the Fenugreek supplement.
The study used a quasi-experimental pretest-posttest design. Participants' weight (BMI), fasting blood sugar (FBS), random blood sugar (RBS), and HbA1c were measured at the start and monitored throughout the three-month period. Data were collected from local clinics and hospitals that serve people with diabetes in the region.
This study aims to provide evidence on the potential role of Fenugreek as a safe, culturally accepted, and cost-effective supplement that can support diabetes management and reduce obesity-related complications in the Saudi population
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel groups. One group received Fenugreek seed powder along with standard diabetes treatment, while the other group received standard treatment only. Each participant remained in their assigned group for the full duration of the 3-month study period, with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Fenugreek Supplementation | Experimental | Other: Fenugreek Seed Powder40 Participants in this group received 10 grams of Fenugreek seed powder twice daily (before breakfast and dinner) for 3 months, in addition to their usual diabetes treatment and a standard meal plan. |
| Arm 2: Standard Care Only | No intervention | –40 Participants in this group continued their usual diabetes treatment and followed a standard meal plan. They did not receive the Fenugreek supplement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older
- Diagnosed with type 2 diabetes mellitus
- Body Mass Index (BMI) classified as overweight or obese
- Receiving standard diabetes treatment (e.g., oral hypoglycemic agents)
- Able and willing to provide informed consent
Key exclusion criteria (8 listed)
- Diagnosed with type 1 diabetes mellitus
- Currently using insulin therapy
- Pregnant or breastfeeding women
- Known allergy or sensitivity to Fenugreek
- Diagnosed gastrointestinal diseases or malabsorption conditions
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 |
|---|---|---|
| Fenugreek Seed PowderParticipants in the intervention group received 10 grams of ground Fenugreek seed powder, administered twice daily (before breakfast and dinner), for a total of 3 months. The Fenugreek powder was consumed mixed with water, in addition to the participants' regular antidiabetic medications and a standardized meal plan. The supplement was provided in a non-encapsulated, natural powdered form, and was not combined with any other herbal or pharmaceutical products. | Other | Arm 1: Fenugreek Supplementation |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: Baseline and 3 months after intervention
BMI will be calculated as weight in kilograms divided by the square of height in meters (kg/m²).
3 secondary outcomes
Change in Fasting Blood Sugar (FBS)
Time frame: Baseline and 3 months after intervention
Change in Random Blood Sugar (RBS)
Time frame: Baseline and 3 months after intervention
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline and 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Results publication: PubMed 24438170Neelakantan N, Narayanan M, de Souza RJ, van Dam RM. Effect of fenugreek (Trigonella foenum-graecum L.) intake on glycemia: a meta-analysis of clinical trials. Nutr J. 2014 Jan 18;13:7. doi: 10.1186/1475-2891-13-7.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) with other researchers. The data collected will be used solely for the purposes outlined in the approved research protocol and will remain confidential. Any future data sharing (if considered) would require additional ethical clearance and participant consent.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenugreek Seed Powder in people with Type 2 Diabetes Mellitus (T2DM) and Obesity and Type 2 Diabetes, run by University of Hail at 1 site in Saudi Arabia.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Body Mass Index (BMI) (time frame: Baseline and 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07038577, which also lists 1 linked publication.
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 26 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.