The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis

NCT03710538 | Completed

• 1 other identifier: SNACK_CF
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to test the feasibility and effectiveness of a pre-meal snack to reduce the postprandial glycemia (PPG) excursion after a breakfast consumption in adult patients with cystic fibrosis (CF). The investigators also want to investigate the impact of a postprandial exercise to reduce the PPG excursion. An improvement in PPG excursions can improve the condition of CF patients primarily by delaying the onset of cystic fibrosis related diabetes (CFRD) and / or by reducing the risk of lung function loss.

Conditions

Cystic Fibrosis

Keywords

glycemia

Outcome Measures

Primary Outcomes (1)

• Total area under the curve for plasma glucose

  Overall study period (4 hours)

Secondary Outcomes (12)

• Area under the curve for plasma glucose

  From start of study to breakfast time (1 hour)

• Area under the curve for plasma glucose

  From time of breakfast to the end of the study (3 hours)

• Total area under the curve for insulin

  Overall study period (4 hours)

• Area under the curve for insulin

  From start of study to breakfast time (1 hour)

• Area under the curve for insulin

  From breakfast time to the end of the study (3 hours)

Study Arms (4)

[Placebo + Sedentary]

NO INTERVENTION

1\) Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women; Sedentary activities throughout the study

[Snack effect + Sedentary]

EXPERIMENTAL

2\) Consumption of 200ml of soy beverage + 90g of carbohydrate (CHO) breakfast for men and 80g for women; Sedentary activities throughout the study

Dietary Supplement: Snack beverage

[Placebo + Exercise]

EXPERIMENTAL

3\) Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5);

Behavioral: Exercise

[Snack + Exercise]

EXPERIMENTAL

4\) Consumption of 200ml of soy beverage + breakfast of 90g of carbohydrate (CHO) breakfast for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5).

Dietary Supplement: Snack beverage; Behavioral: Exercise

Interventions

Snack beverage DIETARY_SUPPLEMENT

Consumption of a 200ml of soy beverage (100Kcal, 11g CHO, 6g proteins, 4g fat)

[Snack + Exercise]; [Snack effect + Sedentary]

Exercise BEHAVIORAL

3min walk at 60% VO2max every 30 minutes,(x5)

[Placebo + Exercise]; [Snack + Exercise]

Eligibility Criteria

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

You may qualify if:

• Diagnosis of cystic fibrosis,
• Be over 18 years old.

You may not qualify if:

• Pharmacological treatment for cystic fibrosis related diabetes.
• Signs of secondary infection: the test will be practiced at least 1 month after the end of infection treatment
• People with severe gastrointestinal illness (Crohn's disease, celiac disease and a recent history (\<1 year) of bowel obstruction).
• Allergy to one of the ingredients of the menu (example: celiac disease)
• According to the judgment of the investigator, medications or conditions that could interfere with glucose metabolism (eg: oral steroids)
• Pregnancy in progress
• Corrector or potentiator prescribed whose dose is not stable the last 2 months.

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de Recherches Cliniques de Montréal (IRCM)

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rémi Rabasa-Lhoret, MD, PhD

  IRCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: snack beverage or flavored placebo will be not recognizable
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women; Sedentary activities throughout the study \[condition control\] 2. Consumption of 200ml of soy beverage + 90g of carbohydrate (CHO) breakfast for men and 80g for women; Sedentary activities throughout the study \[snack effect on PPG excursion\] 3. Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5); \[exercise effect on the PPG excursion\] 4. Consumption of 200ml of soy beverage + breakfast of 90g of carbohydrate (CHO) breakfast for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5). \[Combined snack and exercise effect on the PPG excursion\]

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: October 18, 2018
• Study Start: April 1, 2019
• Primary Completion: May 26, 2022
• Study Completion: December 31, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)