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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Nimrah Tahir, Mphil food and nutrition
- Telefonnummer: +923314568232
- E-post: nimrahtahir1999@gmail.com
Studer Kontakt Backup
- Navn: Dr. Waqas Ahmad
- Telefonnummer: +92 333 5950108
- E-post: waqas.niaz@uvas.edu.pk
Studiesteder
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Sheikhupura, Pakistan, 39359
- Sultan Hospital
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Ta kontakt med:
- Nimrah Tahir
- Telefonnummer: 03314568232
- E-post: nimrahtahir1999@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: 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.
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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change in HbA1c concentration (%) from baseline to week 12 in 30 overweight and obese patients with type 2 diabetes mellitus
Tidsramme: 12 weeks
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12 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Weight in kg
Tidsramme: 12 weeks
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12 weeks
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Height in meter
Tidsramme: 12 weeks
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12 weeks
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Waist circumference in cm
Tidsramme: 12 weeks
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12 weeks
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Hip circumference in cm
Tidsramme: 12 weeks
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12 weeks
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Fat free mass in kg
Tidsramme: 12 weeks
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12 weeks
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Visceral fat level in cm²
Tidsramme: 12 weeks
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12 weeks
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Dr. Waqas Ahmad, UVAS
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Ajwa Seed-DM
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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