Effect of Prebiotics in Saudi Adults With Type 2 Diabetes

NCT07464691 | Not Yet Recruiting

• 1 other identifier: 23-0053
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Metabolic Health; Inflammation; Gut Microbiome; Obesity

Keywords

Prebiotics; Dietary supplement; Gut Microbiome; Oligofructose

Outcome Measures

Primary Outcomes (3)

• Change in fasting blood glucose

  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

  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

  Change in glycated hemoglobin (HbA1c) (%) measured using standard laboratory assays.

  Baseline, week 4, week 8, and week 12.

Secondary Outcomes (12)

• Change in Body Mass Index (BMI)

  Baseline, week 4, week 8, and week 12

• Change in Waist Circumference

  Baseline, week 4, week 8, and week 12.

• Change in Hip Circumference

  Baseline, week 4, week 8, and week 12.

• Change in Body Composition

  Baseline and week 12.

• Change in Total Cholesterol

  Baseline, week 4, week 8, and week 12

Study Arms (2)

Intervention "Oligofructose"

EXPERIMENTAL

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

Control "Maltodextrin"

PLACEBO COMPARATOR

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)

Interventions

oligofructose DIETARY_SUPPLEMENT

Dose: 16 g/day (two 8 g doses) Form: Powder, dissolved in warm drinks Route: Oral

Intervention "Oligofructose"

Maltodextrin (Placebo) DIETARY_SUPPLEMENT

Dose: 8 g/day (two 4 g doses) Form: Powder, dissolved in warm drinks Route: Oral

Control "Maltodextrin"

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%
• hour post-load glucose \< 140 mg/dl (7.8 mmol/l)

You may not qualify if:

• 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.
• Diabetic patients on acarbose, metformin (\> 1 g/day), and GLP-1 medications.
• Use of antibiotic drugs for the last 3 months of treatments that influence gut microbiota composition.
• Bypass surgery, Laparoscopic Sleeve Gastrectomy (LSG), or colon restriction.
• Chronic gastrointestinal disorder (except irritable bowel syndrome).
• Patients with a history or symptoms of obstruction or Inflammatory bowel disease
• Atypical diets (such as vegetarians, vegans, and heavy consumption of dietary supplements).
• 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.
• Autonomic neuropathy
• Any immune-compromised disease.
• Daily alcohol consumption \> 30 g.
• Involvement in another clinical trial in the past 6 months.
• Any legal incompetence or mental inability to provide consent.

Sponsors & Collaborators

• Princess Nourah Bint Abdulrahman University: lead

Study Sites (1)

King Abdullah bin Abdulaziz University Hospital

Riyadh, 11564, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation; Obesity

Interventions

oligofructose; maltodextrin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Officials

• Nahla M. Bawazeer, PhD

  Princess Nourah Bint Abdulrahman University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nahla M. Bawazeer, PhD

CONTACT

00966 11 822 0000; NMBawazeer@pnu.edu.sa

Abeer S. Alzaben, PhD

CONTACT

ASAlzaben@pnu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study. Participants, care providers, and outcome assessors are unaware of whether participants receive oligofructose or placebo. Only the investigator responsible for randomization knows the group assignments to allocate participants correctly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This study uses a parallel, double-blind, randomized, placebo-controlled design. One hundred adults (50 with type 2 diabetes and 50 healthy controls) will be randomly assigned to receive either oligofructose or a placebo twice daily for 12 weeks. Participants remain in their assigned group for the entire study, and neither participants nor researchers know which intervention is given. Outcomes, including glycemic control, lipid profile, inflammatory markers, and gut microbiota composition, will be compared between groups at baseline and after 4, 8, and 12 weeks.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 11, 2026
• Study Start (Estimated): September 13, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)