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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Dietary supplement: Snack beverage; Behavioral: Exercise

Detailed Description

The investigators are proposing a randomized pilot study to explore the impact of a soy beverage of carbohydrates and protein early in the morning, to stimulate and initiate secretion of Insulin to reduce PPG excursions of the following a lunch in adult patients with CF. Investigators will also study the impact of a post meal exercise on the PPG excursion. Fourteen participants will be included and will each perform a 4-hour intervention in cross over design according to those 4 following experimental conditions:

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] Main result: plasma glucose area under the curve. The underlying mechanisms, insulin, incretin hormones (GLP-1 and GIP), acceptability and side effects (mealtime hyperglycaemia) should also be measured. At the end of this pilot project, the investigators will have established a pre-meal snack and/ or postprandial exercise have a positive impact on PPG.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1R7
      • Institut de recherches cliniques de Montréal (IRCM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: [Placebo + Sedentary]; 1) Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women; Sedentary activities throughout the study
Experimental: [Snack effect + Sedentary]; 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; Consumption of a 200ml of soy beverage (100Kcal, 11g CHO, 6g proteins, 4g fat)
Experimental: [Placebo + Exercise]; 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; 3min walk at 60% VO2max every 30 minutes,(x5)
Experimental: [Snack + Exercise]; 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; Consumption of a 200ml of soy beverage (100Kcal, 11g CHO, 6g proteins, 4g fat); Behavioral: Exercise; 3min walk at 60% VO2max every 30 minutes,(x5)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total area under the curve for plasma glucose	Overall study period (4 hours)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
Mean plasma glucose	Overall study period (4 hours)
Mean insulin	Overall study period (4 hours)
Percentage of time with plasma glucose concentration above 8.0 mmol/L	Overall study period (4 hours)
Percentage of time with plasma glucose concentration above 10.0 mmol/L	Overall study period (4 hours)
Percentage of time with plasma glucose concentration above 11.0 mmol/L	Overall study period (4 hours)
Percentage of time with plasma glucose concentration below 4.0 mmol/L	Overall study period (4 hours)
Post-breakfast peak plasma glucose	1 hour after breakfast

Collaborators and Investigators

• Sponsor: Institut de Recherches Cliniques de Montreal
• Investigators: Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD, IRCM

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): May 26, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: glycemia
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: SNACK_CF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No