An interventional study of oligofructose and Maltodextrin (Placebo) in Type 2 Diabetes, Metabolic Health and Inflammation, sponsored by Princess Nourah Bint Abdulrahman University. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Princess Nourah Bint Abdulrahman University · Not applicable, Interventional, and Treatment
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Princess Nourah Bint Abdulrahman University is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cases:
Controls: (subjects with normal OGTT results)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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: 16 g/day (two 8 g doses) Form: Powder, dissolved in warm drinks Route: Oral
Dose: 8 g/day (two 4 g doses) Form: Powder, dissolved in warm drinks Route: Oral
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 12
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.
Change in HbA1c
Change in glycated hemoglobin (HbA1c) (%) measured using standard laboratory assays.
Time frame: Baseline, week 4, week 8, and week 12.
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 12
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.
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.
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.
Change in Total Cholesterol
Change in total cholesterol (mmol/L) measured from fasting blood samples using standard laboratory methods.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 12
Plan to share: 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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Studies of the drug tested here: Oligofructose
Princess Nourah Bint Abdulrahman University