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

NCT07673523 | Active Not Recruiting

• 1 other identifier: KA-24037
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Continuous Glucose Measuring Device Measurements

  From the enrollment to the end of treatment at 8 weeks

Secondary Outcomes (1)

• Other measurements

  From the enrollment to the end of the treatment at 12 weeks

Study Arms (3)

30% of the daily energy requirement is provided from carbohydrates, not to fall below 130 g/day carb

EXPERIMENTAL

Other: Dietary carbohydrate 30%

50-55% of the daily energy requirement is provided from carbohydrates

EXPERIMENTAL

Other: Dietary carbohydrate 50-55%

carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supp

EXPERIMENTAL

Dietary Supplement: fructooligosaccharide and inulin

Interventions

fructooligosaccharide and inulin DIETARY_SUPPLEMENT

Carbohydrate content of diet

carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supp

Dietary carbohydrate 30% OTHER

Dietary carbohydrate is 30% of daily energy requirements

30% of the daily energy requirement is provided from carbohydrates, not to fall below 130 g/day carb

Dietary carbohydrate 50-55% OTHER

Dietary carbohydrate is 50-55% of daily energy requirements

50-55% of the daily energy requirement is provided from carbohydrates

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

fructooligosaccharide; Inulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: May 11, 2026
• Primary Completion: July 20, 2026
• Study Completion: July 27, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-05

Locations

TU (1)