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

Cystic Fibrosis Clinical Trial

— SNACK_CF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710538
• Other study ID #: SNACK_CF
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 31, 2022
• Est. primary completion date: May 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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)

Locations

Country	Name	City	State
Canada	Institut de Recherches Cliniques de Montréal (IRCM)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total area under the curve for plasma glucose		Overall study period (4 hours)
Secondary	Area under the curve for plasma glucose		From start of study to breakfast time (1 hour)
Secondary	Area under the curve for plasma glucose		From time of breakfast to the end of the study (3 hours)
Secondary	Total area under the curve for insulin		Overall study period (4 hours)
Secondary	Area under the curve for insulin		From start of study to breakfast time (1 hour)
Secondary	Area under the curve for insulin		From breakfast time to the end of the study (3 hours)
Secondary	Mean plasma glucose		Overall study period (4 hours)
Secondary	Mean insulin		Overall study period (4 hours)
Secondary	Percentage of time with plasma glucose concentration above 8.0 mmol/L		Overall study period (4 hours)
Secondary	Percentage of time with plasma glucose concentration above 10.0 mmol/L		Overall study period (4 hours)
Secondary	Percentage of time with plasma glucose concentration above 11.0 mmol/L		Overall study period (4 hours)
Secondary	Percentage of time with plasma glucose concentration below 4.0 mmol/L		Overall study period (4 hours)
Secondary	Post-breakfast peak plasma glucose		1 hour after breakfast