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Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus

Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide (FOS) Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07673523
Enrollment
30
Registered
2026-06-29
Start date
2026-05-11
Completion date
2026-07-27
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus, Dietary treatment, Carbohdyrate intake, Inulin Supplementation, Continuous Glucose Monitoring

Brief summary

Diabetes is a chronic metabolic disease in which nutrients such as carbohydrates, fats and proteins cannot be utilized sufficiently due to the inability to produce insulin or defects in the effect of the produced insulin. The risk of individuals encountering complications related to diabetes decreases when glycemic control is achieved in these patients. Therefore, nutrition is an necessary component of treatment. Although there are many studies in the literature examining the effect of carbohydrate intake on glycemic control in individuals with diabetes and monitoring carbohydrate intake in individuals with diabetes is the basic strategy for reaching glucose targets, a common denominator has not yet been reached for the optimal amount of carbohydrate intake for individuals with diabetes. There are a wide range of definitions regarding carbohydrate intake and studies on carbohydrate restriction, especially in individuals with Type 1 diabetes, are limited. In present randomized controlled crossover study, three isocaloric different dietary treatment are planned to applied for 2 weeks in which (i) 30% of the daily energy requirement is provided from carbohydrates, not to fall below 130 g/day carbohydrates according to the individual characteristics of the patients, (ii) 50-55% of the daily energy requirement is provided from carbohydrates and (iii) carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supplementing 2 sachets (1 sachet 3.68 g inulin + 3.68 g ) where 50-55% of daily energy requirement is provided from carbohydrates together with fructooligosaccharide (FOS)) inulin fructooligosaccharide (FOS) supplementation. A 2-week washout period is planned between each diet model. The research will be conducted with 20 individuals with Type 1 diabetes using a Continuous Glucose Monitoring device. The proposed project aims to investigate the effect of different dietary treatments on glycemic control in individuals with Type 1 diabetes by using a continuous glucose measuring device. At the end of each dietary treatment application, the data obtained from the Continuous Glucose Measuring Device will be evaluated as the primary outcomes; total insulin dose, insulin/Carbohydrate ratio, total bolus insulin dose will be evaluated as the secondary outcomes. As a result of the research, the potential effects of different dietary treatments on glycemic control will be evaluated and the development of the most appropriate diet model for these patients will be contributed. In addition, this research will contribute to the improvement of the continuous glucose monitoring device.

Interventions

DIETARY_SUPPLEMENTfructooligosaccharide and inulin

Carbohydrate content of diet

OTHERDietary carbohydrate 30%

Dietary carbohydrate is 30% of daily energy requirements

OTHERDietary carbohydrate 50-55%

Dietary carbohydrate is 50-55% of daily energy requirements

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Patients aged 18-65 years diagnosed with Type 1 diabetes and currently using a Continuous Glucose Monitoring device

Exclusion criteria

* Individuals with type 2 diabetes * Individuals with gestational diabetes * Breastfeeding individuals * Individuals with celiac disease * Individuals with gastroparesis * Renal insufficiency (tGFR ≤ 60 ml/min/1.73 m2) * Diagnosed liver failure * Immunodeficiency * Individuals with malignancy * Using nutritional supplements that may affect metabolic parameters

Design outcomes

Primary

MeasureTime frame
Continuous Glucose Measuring Device MeasurementsFrom the enrollment to the end of treatment at 8 weeks

Secondary

MeasureTime frameDescription
Other measurementsFrom the enrollment to the end of the treatment at 12 weekstotal insulin dose, insulin/Carbohydrate ratio, total bolus insulin dose

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026