Type 2 DiabetesNCT07464691
Effect of Prebiotics in Saudi Adults With Type 2 Diabetes
A study testing oligofructose in people with Type 2 Diabetes and Metabolic Health, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Metabolic Health, Inflammation
- What is being tested?
- oligofructose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 13 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
- 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.
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- 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).
- Use of pre/probiotics or fiber supplements within 3 months before inclusion.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abeer S. Alzaben, PhD contact
Saudi Arabia1 site
King Abdullah bin Abdulaziz University Hospital
Riyadh, 11564
Nahla M. Bawazeer, PhD, NMBawazeer@pnu.edu.sa
Abeer S. Alzaben, PhD, ASAlzaben@pnu.edu.sa
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Metabolic Health, Inflammation, Gut Microbiome, Obesity
- Being tested
- oligofructose, Maltodextrin (Placebo)
- Keywords
- Prebiotics, Dietary supplement, Gut Microbiome, Oligofructose
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oligofructoseDietary 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting blood glucose
Change in fasting blood glucose (mmol/L) from baseline, measured from venous blood samples collected using standard laboratory assays.
Measured: 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.
Measured: Baseline, week 4, week 8, and week 12.
Change in HbA1c
Change in glycated hemoglobin (HbA1c) (%) measured using standard laboratory assays.
Measured: Baseline, week 4, week 8, and week 12.
Secondary outcomes (12)
Change in Body Mass Index (BMI)
Change in body mass index calculated as weight (kg) divided by height squared (m²).
Measured: Baseline, week 4, week 8, and week 12
Change in Waist Circumference
Change in waist circumference measured using a flexible measuring tape (measured in cm).
Measured: Baseline, week 4, week 8, and week 12.
Change in Hip Circumference
Change in hip circumference measured using a flexible measuring tape (measured in cm).
Measured: Baseline, week 4, week 8, and week 12.
Change in Body Composition
Change in body composition (% body fat) assessed using bioelectrical impedance analysis (BIA) and/or dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline and week 12.
Change in Total Cholesterol
Change in total cholesterol (mmol/L) measured from fasting blood samples using standard laboratory methods.
Measured: Baseline, week 4, week 8, and week 12
Change in LDL cholesterol
Change in LDL cholesterol (mmol/L) measured from fasting blood samples using standard laboratory methods.
Measured: Baseline, week 4, week 8, and week 12.
Change in HDL Cholesterol
Change in HDL cholesterol (mmol/L) measured from fasting blood samples using standard laboratory methods.
Measured: Baseline, week 4, week 8, and week 12.
Change in serum Triglycerides level
Change in triglycerides level (mmol/L) measured from fasting blood samples using standard laboratory methods.
Measured: Baseline, week 4, week 8, and week 12.
Change in serum C-Reactive Protein (CRP)
Change in inflammatory marker serum levels of CRP (mg/L) measured from fasting blood samples using ELISA assays.
Measured: Baseline, week 4, week 8, and week 12
Change in serum Interleukin-6 (IL-6)
Change in inflammatory marker serum levels of IL-6 (pg/mL) measured from fasting blood samples using ELISA assays.
Measured: Baseline, week 4, week 8, and week 12.
Change in serum Tumor Necrosis Factor-alpha (TNF-α)
Change in serum TNF-α levels (pg/mL) measured from fasting blood samples using ELISA.
Measured: Baseline, week 4, week 8, and week 12.
Change in Gut Microbiota Composition
Change in abundance and diversity of specific gut bacterial species, including bifidobacteria, assessed by analysis of stool samples using 16S rRNA sequencing.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start13 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Nourah Bint Abdulrahman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Mohammed Bawazeer, Princess Nourah Bint Abdulrahman University
- Investigators
- Nahla M. Bawazeer, PhD, Principal investigator, Princess Nourah Bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464691
- Sponsor's protocol ID
- 23-0053
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prebiotics in Saudi Adults With Type 2 Diabetes: Randomized Control Trail
- ClinicalTrials.gov ID
- NCT07464691
- Acronym / sponsor ID
- 23-0053
- Conditions
- Type 2 Diabetes, Metabolic Health, Inflammation, Gut Microbiome, Obesity
- Keywords
- Prebiotics, Dietary supplement, Gut Microbiome, Oligofructose
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Princess Nourah Bint Abdulrahman UniversityUniversity, hospital or other
- Study start
- 13 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention "Oligofructose" | Experimental | Dietary Supplement: oligofructoseParticipants 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. |
| Control "Maltodextrin" | Placebo comparator | Dietary Supplement: Maltodextrin (Placebo)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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
- Type 2 diabetes.
Key exclusion criteria (17 listed)
- 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
- Diabetic patients on acarbose, metformin (> 1 g/day), and GLP-1 medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oligofructoseDose: 16 g/day (two 8 g doses) Form: Powder, dissolved in warm drinks Route: Oral | Dietary supplement | Intervention "Oligofructose" |
| Maltodextrin (Placebo)Dose: 8 g/day (two 4 g doses) Form: Powder, dissolved in warm drinks Route: Oral | Dietary supplement | Control "Maltodextrin" |
Primary outcome
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.
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.
Change in HbA1c
Time frame: Baseline, week 4, week 8, and week 12.
Change in glycated hemoglobin (HbA1c) (%) measured using standard laboratory assays.
12 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline, week 4, week 8, and week 12
Change in Waist Circumference
Time frame: Baseline, week 4, week 8, and week 12.
Change in Hip Circumference
Time frame: Baseline, week 4, week 8, and week 12.
Change in Body Composition
Time frame: Baseline and week 12.
Change in Total Cholesterol
Time frame: Baseline, week 4, week 8, and week 12
Change in LDL cholesterol
Time frame: Baseline, week 4, week 8, and week 12.
Change in HDL Cholesterol
Time frame: 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 serum C-Reactive Protein (CRP)
Time frame: 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 serum Tumor Necrosis Factor-alpha (TNF-α)
Time frame: Baseline, week 4, week 8, and week 12.
Change in Gut Microbiota Composition
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abeer S. Alzaben, PhD contact
Nahla M. Bawazeer, PhD principal investigator
Princess Nourah Bint Abdulrahman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oligofructose in people with Type 2 Diabetes and Metabolic Health, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nahla M. Bawazeer, PhD (00966 11 822 0000 ext. 41567, NMBawazeer@pnu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting blood glucose (time frame: Baseline, week 4, week 8, and week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.