Effect of Prebiotics in Saudi Adults With Type 2 Diabetes

Sponsor
Princess Nourah Bint Abdulrahman University
Study ID
NCT07464691
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • oligofructose — DIETARY_SUPPLEMENT
    Dose: 16 g/day (two 8 g doses) Form: Powder, dissolved in warm drinks Route: Oral
  • Maltodextrin (Placebo) — DIETARY_SUPPLEMENT
    Dose: 8 g/day (two 4 g doses) Form: Powder, dissolved in warm drinks Route: Oral

Study Details

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.

Key Dates

First listed
Mar 11, 2026
Start date
Sep 13, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention "Oligofructose"
    Participants will receive a daily 16 g oligofructose supplement (32 kcal/day) in sachets, divided into two 8 g doses, to be dissolved in warm drinks such as coffee, tea, or milk and consumed before meals. During the first week, participants will take half the daily dose to allow gradual adjustment to dietary fiber and minimize gastrointestinal discomfort.
  • Placebo Comparator: Control "Maltodextrin"
    Participants will receive an equal-calorie maltodextrin placebo (8 g/day) in sachets, divided into two daily doses for 12 weeks. The powder will be dissolved in warm drinks such as coffee, tea, or milk and consumed before meals, following the same procedure as the oligofructose group. During the first week, participants will take half the daily dose to allow gradual adjustment.

Primary Outcome Measure

Change in fasting blood glucose [ Time Frame: Baseline, week 4, week 8, and week 12 ]

Central Contacts

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