Effect of Ajwa Seed Powder on HbA1c and Body Composition in Overweight and Obese Patients With Type 2 Diabetes Mellitus

Effect of Ajwa Seed Powder on HbA1c and Body Composition in Overweight and Obese Patients With Type 2 Diabetes Mellitus: A Single-Arm Interventional Stuy

The goal of this interventional study (clinical trial) is to check if ajwa seed powder can treat type 2 diabetes mellitus in overweight and and obese patients with type 2 diabetes mellitus including both male and female of the age group between 30-50. The main question is what would be the impact of ajwa seed powder on HbA1c and body composition in overweight and obese patients with type 2 diabetes mellitus which aim to

result in better glycemic control particular Hba1c, and body composition improvement in type 2 diabetes mellitus patients

Participants will be asked to consume 4 grams of ajwa seed powder per day

Study Overview

Status

Not yet recruiting

Detailed Description

Background:

Ajwa seeds (Phoenix dactylifera L.) exhibit anti-obesity, antihyperglycemic, and antioxidative activities, with enhancements in body composition and HbA1c levels. However, there have been very few studies investigating the combined impact of these activities in obese or overweight diabetic individuals. Therefore, the aim of this study is to examine the impact of Ajwa seed powder on body composition and HbA1c levels among this group of individuals. The study supports sustainable development goals 2 & 3 (Zero Hunger, Good Health and well-being) respectively.

Research Questions

• What would be the impact of ajwa seed powder on HbA1c and body composition in overweight and obese patients with type 2 diabetes mellitus?

Hypothesis:

Ajwa seed powder supplementation shows considerable potential to improve body composition and glycemic control among overweight/obese individuals suffering from type 2 diabetes mellitus.

Objectives

  • To study the impact of Ajwa seed powder supplementation on HbA1c concentration in patients suffering from type 2 diabetes mellitus who are either overweight or obese.
  • To study any alteration in the parameters of body composition, such as fat mass, visceral fat, and muscle mass, after a 12-week intervention with Ajwa seed powder.

Experimental design An interventional study will be conducted in Lahore, Pakistan, over 12 weeks. The study will consist of 30 adults aged 30-50 years with BMI (25-35 kg/m²) and HbA1c>6.5%.

On consuming Ajwa seeds in powdered form (4 grams per day, in form of either capsules or sachets), participants' HbA1c, body compositions (weight, BMI, waist/hip circumference, fat mass, fat free mass, visceral fat mass) will be assessed using In Body bioelectrical impedance analyzer before and after the intervention.

Statistical analysis The statistical analysis will be performed using the SPSS version 25.0. The paired t-test analysis and the Pearson correlation coefficient will be analyzed.

Expected outcome It is expected that the supplementation of Ajwa seed powder will result in better glycemic control, lean body mass maintenance, and body composition improvement in Type 2 diabetes mellitus patient

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age: 30-50 years
  • Gender: Male/female
  • Body Mass Index (BMI): 25-35 kg/m²
  • Type 2 diabetes mellitus: HbA1c ≥ 6.5% Exclusion criteria History of alcoholic liver disease or cirrhosis; liver dysfunction based on initial blood tests
  • Patients being treated with insulin
  • High initial levels of serum creatinine (men>1.5 mg/dl; women>1.2 mg/dl)
  • Pregnant/lactating females or women who cannot take proper contraceptive measures
  • Symptoms consistent with peptic ulcer disease or history of peptic ulcers
  • Active cancer patients
  • Severe non-diabetes-related illnesses
  • Patients with heart, liver, or lung failures
  • Patients with blood disorders or on anticoagulant drugs such as warfarin Any other disease as decided by the principal investigator, which might put the safety of the subjects at risk while conducting the test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ajwa Seed powder group
This will be Single Arm interventional Study in which overweight or obese adults aged 30-50 years with Type 2 Diabetes (HbA1c >6.5% and BMI 25-35 kg/m²) will receive Ajwa seed powder supplementation (4 g/day in the form of capsules or sachets) for 12 weeks. HbA1c levels and body composition parameters, including body weight, BMI, waist/hip circumference, fat mass, fat-free mass, visceral fat, and muscle mass, will be assessed before and after the intervention using an InBody bioelectrical impedance analyzer.

The intervention in this study is Ajwa (Phoenix dactylifera) seed powder, a natural plant-based product obtained from Ajwa dates. It is distinguished from other clinical interventions by its botanical origin, absence of chemical modification, and standardized preparation process, which includes cleaning, drying, and grinding into a uniform powder form.

A fixed dose is administered to all participants in the intervention arm according to the study protocol. Unlike pharmaceutical or biologic interventions, it is a non-pharmacological dietary supplement intended for metabolic support.

The intervention specifically targets HbA1c levels and body composition in diabetic and/or obese individuals, with no additional experimental treatments included. This controlled and standardized approach differentiates it from other clinical or nutritional interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in HbA1c concentration (%) from baseline to week 12 in 30 overweight and obese patients with type 2 diabetes mellitus
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight in kg
Time Frame: 12 weeks
12 weeks
Height in meter
Time Frame: 12 weeks
12 weeks
Waist circumference in cm
Time Frame: 12 weeks
12 weeks
Hip circumference in cm
Time Frame: 12 weeks
12 weeks
Fat free mass in kg
Time Frame: 12 weeks
12 weeks
Visceral fat level in cm²
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dr. Waqas Ahmad, UVAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

July 9, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes (T2DM)

Clinical Trials on Ajwa Seed powder

3
Subscribe