NCT07038577

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 9, 2025

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Body Mass Index (BMI)

    BMI will be calculated as weight in kilograms divided by the square of height in meters (kg/m²).

    Baseline and 3 months after intervention

Secondary Outcomes (3)

  • Change in Fasting Blood Sugar (FBS)

    Baseline and 3 months after intervention

  • Change in Random Blood Sugar (RBS)

    Baseline and 3 months after intervention

  • Change in Hemoglobin A1c (HbA1c)

    Baseline and 3 months after intervention

Study Arms (2)

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.

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.

Interventions

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.

Arm 1: Fenugreek Supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hail

Hail, 55424, Saudi Arabia

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityHyperglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
All participants, care providers, and investigators were aware of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 26, 2025

Study Start

January 1, 2025

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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.

Locations