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
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
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.
Sultan Hospital
Sheikhupura, Pakistan
change in HbA1c concentration (%) from baseline to week 12 in 30 overweight and obese patients with type 2 diabetes mellitus
Time frame: 12 weeks
Weight in kg
Time frame: 12 weeks
Height in meter
Time frame: 12 weeks
Waist circumference in cm
Time frame: 12 weeks
Hip circumference in cm
Time frame: 12 weeks
Fat free mass in kg
Time frame: 12 weeks
Visceral fat level in cm²
Time frame: 12 weeks
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