Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
To ensure allocation concealment and blinding, the placebo and probiotic supplements were identically packaged and the main researcher and participants were blinded to the capsule content throughout t
therefore, we selected 12 weeks to observe the effect of the intervention on the variables.
The placebo was prepared locally with the help of a pharmacist by adding approximately 200 mg of starch to
Sponsors
Arab Board of Health Specializations in IRAQ
Ministry of Health - Baghdad Al-Karkh Health Dirctorate
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals with T2D according to the criteria of the American Diabetes Association (ADA) for at least 10 months prior to study initiation 2. Individuals aged 30–75 years 3. Individuals with an HbA1c level =6.5% 4. Individuals able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Individuals who were current smokers 2. Individuals with immunocompromised conditions 3. Individuals with diabetes controlled by insulin 4. Individuals who were pregnant or breastfeeding 5. Individuals with inflammatory bowel disease; pancreatitis; chronic kidney, hepatic, or pulmonary diseases; severe anaemia; or cancer 6. Individuals using nutritional supplements, laxatives, or nonsteroidal anti-inflammatory drugs in the past 3 weeks 7. Individuals using antibiotics within the past 3 months prior to study initiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1C is measured by venous blood sample at baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed at baseline and 12 weeks: 1. BMI determined by dividing body weight by the square of height (kg/m2) 2. Waist circumference measured using a non-stretchable tape with 0.1-cm accuracy 3. Fasting blood sugar measured using a fasting venous blood sample 4. Lipid profiles measured using a fasting venous blood sample | — |
Countries
Iraq
Contacts
Public ContactSarah Hayder Ali ;Ban Abdul-Ridha Salman Zalzala ;Al-Hashimi
;
Outcome results
None listed