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

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.

Conditions

• Cystic Fibrosis-related Diabetes
• Cystic Fibrosis

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Placebo (for fiber supplementation)

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

Sponsors & Collaborators

• Canadian Cystic Fibrosis Foundation

  collaborator OTHER

• Université de Montréal

  collaborator OTHER

• Institut de Recherches Cliniques de Montreal

  lead OTHER

Principal Investigators

• Rémi Rabasa-Lhoret, MD,PhD · IRCM

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2018-04-30

Completion

2018-04-30

Countries

• Canada

Study Locations