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

NCT ID: NCT03710538

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-12-31

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.

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

[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

Group Type: NO_INTERVENTION

No interventions assigned to this group

[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

Group Type: EXPERIMENTAL

Snack beverage

Intervention Type: DIETARY_SUPPLEMENT

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

[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);

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

[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).

Group Type: EXPERIMENTAL

Snack beverage

Intervention Type: DIETARY_SUPPLEMENT

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

Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Snack beverage

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

Intervention Type: DIETARY_SUPPLEMENT

Exercise

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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

Sponsors

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rémi Rabasa-Lhoret, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCM

Locations

Institut de Recherches Cliniques de Montréal (IRCM)

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

SNACK_CF

Identifier Type: -

Identifier Source: org_study_id