The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis

NCT ID: NCT02810691

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-04-30

Brief Summary

With improved survival, the clinical spectrum of cystic fibrosis (CF), a complex multi systemic disease, continue to evolve. A major emerging complication is CF related diabetes (CFRD) which is occurring in 40-50% of adults. Patients who develop CFRD are at increase risk of morbidity and mortality and they are also facing an increased medical burden with insulin therapy, the only recommended treatment. Accelerated decline in weight and/or pulmonary function start 2 to 4 years before CFRD onset and this period is characterized by frequent Post-Prandial Glycemic (PPG) excursions. Higher PPG excursions are associated with lower pulmonary function and it predicts future CFRD risk. To the improved nutritional status, lung function and survival of patients, the nutritional approach for patients with CF focuses on high-energy high-fat diet and a pancreatic enzyme supplementation. However, such diet also contributes to increased PPG excursions. Based on the beneficial effects of nutrition therapy to improve PPG in other forms of pre-diabetes and diabetes, extending such benefits to patients with CF is important. The investigators aim to test the feasibility and the effectiveness of a viscous fiber supplement to reduce PPG in adult patients with CF. Using a randomized crossover design, the investigators will study the impact of two doses of a viscous fiber supplement as compared to a placebo.

Detailed Description

With improved survival, the clinical spectrum of cystic fibrosis (CF), a complex multi systemic disease, continue to evolve. A major emerging complication is CF related diabetes (CFRD). CFRD is a major co-morbidity occurring in 20% of adolescents and 40-50% of adults and is mainly due to reduced insulin secretion. Patients who develop CFRD are at increase risk of morbidity and mortality and they are also facing an increased medical burden with insulin therapy, the only recommended treatment. Because accelerated decline in weight and/or pulmonary function start 2 to 4 years before CFRD onset and that this period is characterized by frequent Post-Prandial Glycemic (PPG) excursions, the role of these PPG excursions in clinical deterioration have been investigated. The investigators have shown that higher PPG excursions are associated with lower pulmonary function and others have shown that PPG excursions predicts future CFRD risk. Food overconsumption is discouraged in other forms of diabetes to avoid overweight or obesity, but also to prevent an increase in insulin demand. In contrast, nutritional approach for patients with CF focuses on high-energy high-fat diet to meet increased energy requirements. In combination with an appropriate pancreatic enzyme supplementation, this approach contributes significantly to the improved nutritional status, lung function and survival of patients. However, such diet also contributes to increased PPG excursions. Based on the beneficial effects of nutrition therapy to improve PPG in other forms of pre-diabetes and diabetes, extending such benefits to patients with CF is important. In the context of high CF treatment burden, such approach should however be simple and not inducing weight loss. The investigators aim to test the feasibility and the effectiveness of a viscous fiber supplement to reduce PPG in adult patients with CF. Using a randomized crossover design, the investigators will study the impact of two doses of a viscous fiber supplement as compared to a placebo in controlled conditions, in 22 patients, over 8 hours, at the research center with 2 standardized mixed-meals: breakfast and lunch on PPG excursions.

Conditions

Cystic Fibrosis-related Diabetes; Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Soluble fiber, dose #1

Soluble fiber supplementation with dose #1 (smaller dose) of psyllium fiber.

Group Type: ACTIVE_COMPARATOR

Soluble fiber supplementation

Intervention Type: DIETARY_SUPPLEMENT

Two different doses of psyllium powder will be diluted in 250 ml of orange-flavored water and drink in 5 minutes before breakfast.

Soluble fiber, dose #2

Soluble fiber supplementation with dose #2 (bigger dose) of psyllium fiber.

Group Type: ACTIVE_COMPARATOR

Soluble fiber supplementation

Intervention Type: DIETARY_SUPPLEMENT

Two different doses of psyllium powder will be diluted in 250 ml of orange-flavored water and drink in 5 minutes before breakfast.

Placebo

A 250 ml placebo solution of orange-flavored water will be drink at breakfast.

Group Type: PLACEBO_COMPARATOR

Placebo (for fiber supplementation)

Intervention Type: DIETARY_SUPPLEMENT

Placebo will consist of 250 ml of orange-flavored water to be drink in 5 minutes before breakfast.

Interventions

Soluble fiber supplementation

Two different doses of psyllium powder will be diluted in 250 ml of orange-flavored water and drink in 5 minutes before breakfast.

Intervention Type: DIETARY_SUPPLEMENT

Placebo (for fiber supplementation)

Placebo will consist of 250 ml of orange-flavored water to be drink in 5 minutes before breakfast.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Diagnosed with CF
• Aged above 18 years
• CF-Impaired glucose tolerance, CF-indeterminate glucose tolerance (INDET), de-novo diabetes not requiring immediate treatment and diabetes without pharmacological treatment, based on the oral glucose tolerance test (OGTT) performed within three months of the first visit

Exclusion Criteria

• Treated or longstanding CFRD
• Subjects taking medication or affected by conditions that could interfere with glucose metabolism in the last 6 weeks: hemoptysis, fever, IV antibiotic treatment, pregnancy and oral steroids. If a patient presents any sign of infection confirmed by a trained CF pneumologist, OGTT testing is postponed to the next medical appointment 1 months later.
• Subjects with severe gastrointestinal disease (Crohn disease, coeliac disease and recent (<1 year) history of intestinal occlusion).
• Subjects with intestinal obstruction history.
• Allergy to an ingredient in the menu.
• Corrector or potentiator prescribed within the last 6 months prior to the first visit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: collaborator

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Rémi Rabasa-Lhoret

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rémi Rabasa-Lhoret, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

IRCM

Locations

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

SOFI

Identifier Type: -

Identifier Source: org_study_id