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

9. juli 2026 opdateret af: University of Veterinary and Animal Sciences, Lahore - Pakistan

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Kosttilskud: 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 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Weight in kg
Tidsramme: 12 weeks
12 weeks
Height in meter
Tidsramme: 12 weeks
12 weeks
Waist circumference in cm
Tidsramme: 12 weeks
12 weeks
Hip circumference in cm
Tidsramme: 12 weeks
12 weeks
Fat free mass in kg
Tidsramme: 12 weeks
12 weeks
Visceral fat level in cm²
Tidsramme: 12 weeks
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Efterforskere

  • Ledende efterforsker: Dr. Waqas Ahmad, UVAS

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Ajwa Seed-DM

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Type 2-diabetes (T2DM)

Kliniske forsøg med Ajwa Seed powder

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