Effect of Prebiotics in Saudi Adults With Type 2 Diabetes

March 9, 2026 updated by: Nahla Mohammed Bawazeer, Princess Nourah Bint Abdulrahman University

Effect of Prebiotics in Saudi Adults With Type 2 Diabetes: Randomized Control Trail

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes mellitus (T2DM) represents a major public health challenge and is frequently associated with metabolic abnormalities, including dyslipidemia, obesity, and cardiovascular disease. Emerging evidence indicates that the gut microbiota plays a critical role in regulating host metabolism, inflammation, and glucose homeostasis. Alterations in gut microbial composition have been consistently observed in individuals with T2DM and obesity, suggesting that modulation of gut microbiota may represent a therapeutic target for metabolic disease management.

Prebiotics are non-digestible, fermentable dietary components that selectively stimulate the growth and activity of beneficial gut bacteria. Oligofructose, a well-studied prebiotic carbohydrate, resists digestion in the upper gastrointestinal tract and undergoes fermentation in the colon, leading to the production of short-chain fatty acids that influence glucose metabolism, lipid metabolism, appetite regulation, and inflammatory pathways.

Previous human and animal studies have reported mixed but promising results regarding the effects of oligofructose on glycemic control, lipid profiles, body weight, and inflammatory markers. Some studies demonstrated improvements in fasting blood glucose, lipid parameters, insulin sensitivity, and body weight, while others reported limited metabolic effects despite favorable changes in gut microbiota composition. Differences in study populations, dosages, duration, and baseline metabolic status may account for these inconsistencies.

Individuals with T2DM exhibit distinct gut microbiota profiles compared to non-diabetic individuals, including increased abundance of gram-negative bacteria and elevated circulating lipopolysaccharides, which may contribute to metabolic endotoxemia and insulin resistance. However, data regarding the impact of prebiotic supplementation on gut microbiota and metabolic outcomes in the Saudi population are limited.

This study aims to evaluate the effects of oligofructose supplementation on body weight, glycemic control, lipid profile, inflammatory markers, and gut microbiota composition in individuals with type 2 diabetes. Unlike studies using probiotics, this intervention focuses on modulating endogenous gut microbiota through prebiotic supplementation without introducing live microorganisms.

Hypothesis:

Prebiotic oligofructose supplementation will lead to improvements in body weight, glycemic control, lipid profile, and inflammatory status, mediated in part through favorable modulation of gut microbiota composition.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Cases:

  • Type 2 diabetes.
  • Duration of diabetes ≥ 5 years
  • HbA1c ≥ 6.5-8.0

Controls: (subjects with normal OGTT results)

  • Fasting plasma glucose (FPG) < 100 mg/dl (5.6mmol/l)
  • A1C less than 5.7%
  • 2-hour post-load glucose < 140 mg/dl (7.8 mmol/l)

Exclusion Criteria:

  1. Patients with Type 1 diabetes.
  2. Pregnant & breastfeeding females.
  3. Any serious disease such as renal or hepatic disease, thyroid functions, coeliac disease, or the presence of gastroparesis.
  4. Use of weight-loss treatments within 3 months before inclusion
  5. Diabetic patients on acarbose, metformin (> 1 g/day), and GLP-1 medications.
  6. Use of antibiotic drugs for the last 3 months of treatments that influence gut microbiota composition.
  7. Bypass surgery, Laparoscopic Sleeve Gastrectomy (LSG), or colon restriction.
  8. Chronic gastrointestinal disorder (except irritable bowel syndrome).
  9. Patients with a history or symptoms of obstruction or Inflammatory bowel disease
  10. Atypical diets (such as vegetarians, vegans, and heavy consumption of dietary supplements).
  11. Use of pre/probiotics or fiber supplements within 3 months before inclusion.
  12. Any drug that can interfere with food absorption or gut flora, such as chronic consumption of loperamide, cholestyramine, antacids, H2-receptor blockers, proton pump inhibitors, fibrates, corticosteroids, or sex steroids, omega-3 unsaturated fatty acids acid, or anti-inflammatory drugs.
  13. Autonomic neuropathy
  14. Any immune-compromised disease.
  15. Daily alcohol consumption > 30 g.
  16. Involvement in another clinical trial in the past 6 months.
  17. Any legal incompetence or mental inability to provide consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Dietary supplement: oligofructose
Dose: 16 g/day (two 8 g doses) Form: Powder, dissolved in warm drinks Route: Oral
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.
Dietary supplement: Maltodextrin (Placebo)
Dose: 8 g/day (two 4 g doses) Form: Powder, dissolved in warm drinks Route: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting blood glucose
Time Frame: Baseline, week 4, week 8, and week 12
Change in fasting blood glucose (mmol/L) from baseline, measured from venous blood samples collected using standard laboratory assays.
Baseline, week 4, week 8, and week 12
Change in fasting insulin
Time Frame: Baseline, week 4, week 8, and week 12.
Change in fasting insulin (µIU/mL) measured from venous blood samples using standard laboratory assays.
Baseline, week 4, week 8, and week 12.
Change in HbA1c
Time Frame: Baseline, week 4, week 8, and week 12.
Change in glycated hemoglobin (HbA1c) (%) measured using standard laboratory assays.
Baseline, week 4, week 8, and week 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (BMI)
Time Frame: Baseline, week 4, week 8, and week 12
Change in body mass index calculated as weight (kg) divided by height squared (m²).
Baseline, week 4, week 8, and week 12
Change in Waist Circumference
Time Frame: Baseline, week 4, week 8, and week 12.
Change in waist circumference measured using a flexible measuring tape (measured in cm).
Baseline, week 4, week 8, and week 12.
Change in Hip Circumference
Time Frame: Baseline, week 4, week 8, and week 12.
Change in hip circumference measured using a flexible measuring tape (measured in cm).
Baseline, week 4, week 8, and week 12.
Change in Body Composition
Time Frame: Baseline and week 12.
Change in body composition (% body fat) assessed using bioelectrical impedance analysis (BIA) and/or dual-energy X-ray absorptiometry (DEXA).
Baseline and week 12.
Change in Total Cholesterol
Time Frame: Baseline, week 4, week 8, and week 12
Change in total cholesterol (mmol/L) measured from fasting blood samples using standard laboratory methods.
Baseline, week 4, week 8, and week 12
Change in LDL cholesterol
Time Frame: Baseline, week 4, week 8, and week 12.
Change in LDL cholesterol (mmol/L) measured from fasting blood samples using standard laboratory methods.
Baseline, week 4, week 8, and week 12.
Change in HDL Cholesterol
Time Frame: Baseline, week 4, week 8, and week 12.
Change in HDL cholesterol (mmol/L) measured from fasting blood samples using standard laboratory methods.
Baseline, week 4, week 8, and week 12.
Change in serum Triglycerides level
Time Frame: Baseline, week 4, week 8, and week 12.
Change in triglycerides level (mmol/L) measured from fasting blood samples using standard laboratory methods.
Baseline, week 4, week 8, and week 12.
Change in serum C-Reactive Protein (CRP)
Time Frame: Baseline, week 4, week 8, and week 12
Change in inflammatory marker serum levels of CRP (mg/L) measured from fasting blood samples using ELISA assays.
Baseline, week 4, week 8, and week 12
Change in serum Interleukin-6 (IL-6)
Time Frame: Baseline, week 4, week 8, and week 12.
Change in inflammatory marker serum levels of IL-6 (pg/mL) measured from fasting blood samples using ELISA assays.
Baseline, week 4, week 8, and week 12.
Change in serum Tumor Necrosis Factor-alpha (TNF-α)
Time Frame: Baseline, week 4, week 8, and week 12.
Change in serum TNF-α levels (pg/mL) measured from fasting blood samples using ELISA.
Baseline, week 4, week 8, and week 12.
Change in Gut Microbiota Composition
Time Frame: Baseline and Week 12
Change in abundance and diversity of specific gut bacterial species, including bifidobacteria, assessed by analysis of stool samples using 16S rRNA sequencing.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Nourah Bint Abdulrahman University

Investigators

  • Principal Investigator: Nahla M. Bawazeer, PhD, Princess Nourah Bint Abdulrahman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 13, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) from this study will not be shared outside the research team. All data will remain confidential and will be used solely for this study in accordance with institutional ethical guidelines and participants' informed consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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