Effect of Prebiotics in Saudi Adults With Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-60
SponsorPrincess Nourah Bint Abdulrahman University
About this trial
This study will explore how a natural food ingredient called oligofructose affects blood glucose levels, lipid profiles, inflammation biomarkers, and gut bacteria in Saudi adults with type 2 diabetes. Oligofructose is a type of dietary fiber found in foods such as onions, garlic, and bananas. It is known to help the growth of "good" bacteria in the intestine, which may improve digestion and metabolism.
A total of 100 adults (50 with type 2 diabetes and 50 without diabetes) will take part in this research. Participants will be randomly assigned to receive either oligofructose or a placebo twice daily for 12 weeks. Blood tests will be done at the beginning and at weeks 4, 8, and 12 to check changes in blood glucose, lipid profiles, and inflammation.
The goal of this study is to find out whether adding oligofructose to the diet can help people with diabetes improve their blood glucose control, reduce inflammation, and support a healthier balance of gut bacteria.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Saudi, both males and females.
Aged between 45-60 years old
BMI between 25 - 30 kg/m2
No antibiotic use for the last six months
Disqualifiers
Patients with Type 1 diabetes.
Pregnant & breastfeeding females.
Any serious disease such as renal or hepatic disease, thyroid functions, coeliac disease, or the presence of gastroparesis.
Use of weight-loss treatments within 3 months before inclusion
Trial design
Design model
Parallel
Treatments tested in this trial
oligofructose
Dietary supplementDose: 16 g/day (two 8 g doses) Form: Powder, dissolved in warm drinks Route: Oral
Maltodextrin (Placebo)
Dietary supplementDose: 8 g/day (two 4 g doses) Form: Powder, dissolved in warm drinks Route: Oral
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Intervention "Oligofructose"Experimental treatment 1 intervention
Group B: Control "Maltodextrin"Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in fasting blood glucose
Change in fasting blood glucose (mmol/L) from baseline, measured from venous blood samples collected using standard laboratory assays.
Time frame
Baseline, week 4, week 8, and week 122
Change in fasting insulin
Change in fasting insulin (µIU/mL) measured from venous blood samples using standard laboratory assays.
Time frame
Baseline, week 4, week 8, and week 12.3
Change in HbA1c
Change in glycated hemoglobin (HbA1c) (%) measured using standard laboratory assays.
Time frame
Baseline, week 4, week 8, and week 12.Secondary outcomes
1
Change in Body Mass Index (BMI)
Change in body mass index calculated as weight (kg) divided by height squared (m²).
Time frame
Baseline, week 4, week 8, and week 122
Change in Waist Circumference
Change in waist circumference measured using a flexible measuring tape (measured in cm).
Time frame
Baseline, week 4, week 8, and week 12.3
Change in Hip Circumference
Change in hip circumference measured using a flexible measuring tape (measured in cm).
Time frame
Baseline, week 4, week 8, and week 12.4
Change in Body Composition
Change in body composition (% body fat) assessed using bioelectrical impedance analysis (BIA) and/or dual-energy X-ray absorptiometry (DEXA).
Time frame
Baseline and week 12.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: