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

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Пищевая добавка Ajwa Seed powder
  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 inte

Первичные конечные точки

• change in HbA1c concentration (%) from baseline to week 12 in 30 overweight and obese patients with type 2 diabetes mellitus [Срок оценки: 12 weeks]

Вторичные конечные точки (6)

• Weight in kg [Срок оценки: 12 weeks]
• Height in meter [Срок оценки: 12 weeks]
• Waist circumference in cm [Срок оценки: 12 weeks]
• Hip circumference in cm [Срок оценки: 12 weeks]
• Fat free mass in kg [Срок оценки: 12 weeks]
• Visceral fat level in cm² [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Пакистан · 1 центр

• Sultan Hospital — Sheikhupura

Идентификаторы

NCT: NCT07702097 · Ajwa Seed-DM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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