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Evidence suggests that prebiotic fibre can correct dysbiosis, reduce intestinal permeability and improve glycemic control. The investigators hypothesize that microbial changes induced by prebiotics contribute to gut and endocrine adaptations that reduce glucose fluctuations, including less hyper- and hypoglycemia in type 1 diabetes (T1D). The primary objective is to compare the change in frequency of hypoglycemia from baseline to 6 months in n=144 individuals with T1D treated with a 6-month course of prebiotic or placebo as an adjunct to insulin. Secondary objectives will be aimed at understanding the mechanisms by which the prebiotics could affect glycemic control.
The investigators hypothesize that, as an adjunct to insulin, prebiotic supplementation will reduce the frequency of hypoglycemia and improve glycemic variability that is accompanied by enhanced serum C-peptide levels, a reduction in intestinal permeability and systemic inflammation, and altered gut microbiota.
Primary Objective To compare the change in frequency of hypoglycemia from baseline to 6 months in individuals with T1D treated with a 6-month course of prebiotic or placebo as an adjunct to insulin.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prebiotic | Experimental | Oligofructose-enriched inulin |
|
| Placebo | Placebo Comparator | Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic | Dietary Supplement | Chicory root derived inulin-type fructan (13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ages ≥14 years) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of hypoglycemia | Blood glucose <3.9 mmol/L from continuous glucose monitor data | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycemic variability | CGM-recorded composite of percentage of 'time-in-range" (glucose of 3.9-10 mmol/L), "time-below-range" as mild (glucose 3.0-3.9 mmol/L) or moderate (glucose <3.0 mmol/L) hypoglycemia, and "time-above- range" as moderate (glucose 10.1-13.9 mmol/L) and severe (glucose >13.9 mmol/L) hyperglycemia. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dietary intake | 24 hour dietary recall (energy intake, kcal) | 6 months |
| Change in dietary intake | 24 hour dietary recall (fat intake, grams) |
Inclusion Criteria:
Lead Site:
Subsites:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raylene A Reimer, PhD, RD | Contact | 403-220-8218 | reimer@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Raylene A Reimer, PhD, RD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | T2N 1N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40449951 | Derived | Huang C, Rosolowsky E, Nour MA, Butalia S, Ho J, Mayengbam S, Wang W, Pyke S, Virtanen H, Reimer RA. Prebiotic supplementation in patients with type 1 diabetes: study protocol for a randomised controlled trial in Canada. BMJ Open. 2025 May 31;15(5):e102486. doi: 10.1136/bmjopen-2025-102486. |
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De-identified participant data will be available from the corresponding author upon reasonable request.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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Multi-centre placebo controlled double-blind randomized clinical trial
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The prebiotic and placebo are both white powders with similar sweet taste and dissolve in water.
| Placebo | Dietary Supplement | Maltodextrin (isocaloric; 13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ≥14 years) |
|
| Change in glycemic control |
Glycated hemoglobin (A1C) |
| 6 months |
| Change in stimulated C-peptide | Serum collected during a mixed meal tolerance test | 6 months |
| Change in serum proinsulin | Serum collected during a mixed meal tolerance test | 6 months |
| Change in Intestinal permeability | Urinary lactulose/mannitol test | 6 months |
| Change in lipopolysaccharide | Serum lipopolysaccharide concentration | 6 months |
| Change in Inflammatory marker IL-6 | Serum IL-6 | 6 months |
| Change in Inflammatory marker IFN-γ | Serum IFN-γ | 6 months |
| Change in Inflammatory marker TNF | Serum TNF | 6 months |
| Change in Inflammatory marker CRP | Serum CRP | 6 months |
| Change in Inflammatory marker IL-10 | Serum IL-10 | 6 months |
| Change in quality of life | Diabetes-specific quality of life survey | 6 months |
| Change in fear of hypoglycemia | Fear of hypoglycemia ratings survey | 6 months |
| Change in gut microbiota composition | Fecal microbiota taxonomy | 6 months |
| Change in gut microbiota function | Fecal microbiota shotgun sequencing | 6 months |
| Change in serum metabolite concentration | Serum LC-Qtof-Mass Spec metabolomics | 6 months |
| Change in fecal metabolite concentrations | Serum LC-Qtof-Mass Spec metabolomics | 6 months |
| Change in frequency of hypoglycemia post-intervention | Blood glucose <3.9 mmol/L from continuous glucose monitor data | 9 months |
| Change in glycemic variability post-intervention | CGM-recorded composite of percentage of 'time-in-range" (glucose of 3.9-10 mmol/L), "time-below-range" as mild (glucose 3.0-3.9 mmol/L) or moderate (glucose <3.0 mmol/L) hypoglycemia, and "time-above- range" as moderate (glucose 10.1-13.9 mmol/L) and severe (glucose >13.9 mmol/L) hyperglycemia. | 9 months |
| Change in glycemic control post-intervention | Glycated hemoglobin (A1C) | 9 months |
| 6 months |
| Change in dietary intake | 24 hour dietary recall (carbohydrate intake, grams) | 6 months |
| Change in dietary intake | 24 hour dietary recall (protein intake, grams) | 6 months |
| Change in dietary intake | 24 hour dietary recall (fiber intake, grams) | 6 months |
| University of Alberta | Recruiting | Edmonton | Alberta | T6G 1C9 | Canada |
|
| University of Saskatchewan | Recruiting | Saskatoon | Saskatchewan | S7N 5E5 | Canada |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |