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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Snack beverage
Exercise
Sponsored by
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring glycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut de Recherches Cliniques de Montréal (IRCM)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

[Placebo + Sedentary]

[Snack effect + Sedentary]

[Placebo + Exercise]

[Snack + Exercise]

Arm Description

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

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

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);

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).

Outcomes

Primary Outcome Measures

Total area under the curve for plasma glucose

Secondary Outcome Measures

Area under the curve for plasma glucose
Area under the curve for plasma glucose
Total area under the curve for insulin
Area under the curve for insulin
Area under the curve for insulin
Mean plasma glucose
Mean insulin
Percentage of time with plasma glucose concentration above 8.0 mmol/L
Percentage of time with plasma glucose concentration above 10.0 mmol/L
Percentage of time with plasma glucose concentration above 11.0 mmol/L
Percentage of time with plasma glucose concentration below 4.0 mmol/L
Post-breakfast peak plasma glucose

Full Information

First Posted
June 20, 2018
Last Updated
April 24, 2023
Sponsor
Institut de Recherches Cliniques de Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT03710538
Brief Title
The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis
Acronym
SNACK_CF
Official Title
The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 26, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Cliniques de Montreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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] 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] 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] 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
glycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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] 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] 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] 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]
Masking
Participant
Masking Description
snack beverage or flavored placebo will be not recognizable
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[Placebo + Sedentary]
Arm Type
No Intervention
Arm Description
1) Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women; Sedentary activities throughout the study
Arm Title
[Snack effect + Sedentary]
Arm Type
Experimental
Arm Description
2) Consumption of 200ml of soy beverage + 90g of carbohydrate (CHO) breakfast for men and 80g for women; Sedentary activities throughout the study
Arm Title
[Placebo + Exercise]
Arm Type
Experimental
Arm Description
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);
Arm Title
[Snack + Exercise]
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Snack beverage
Intervention Description
Consumption of a 200ml of soy beverage (100Kcal, 11g CHO, 6g proteins, 4g fat)
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
3min walk at 60% VO2max every 30 minutes,(x5)
Primary Outcome Measure Information:
Title
Total area under the curve for plasma glucose
Time Frame
Overall study period (4 hours)
Secondary Outcome Measure Information:
Title
Area under the curve for plasma glucose
Time Frame
From start of study to breakfast time (1 hour)
Title
Area under the curve for plasma glucose
Time Frame
From time of breakfast to the end of the study (3 hours)
Title
Total area under the curve for insulin
Time Frame
Overall study period (4 hours)
Title
Area under the curve for insulin
Time Frame
From start of study to breakfast time (1 hour)
Title
Area under the curve for insulin
Time Frame
From breakfast time to the end of the study (3 hours)
Title
Mean plasma glucose
Time Frame
Overall study period (4 hours)
Title
Mean insulin
Time Frame
Overall study period (4 hours)
Title
Percentage of time with plasma glucose concentration above 8.0 mmol/L
Time Frame
Overall study period (4 hours)
Title
Percentage of time with plasma glucose concentration above 10.0 mmol/L
Time Frame
Overall study period (4 hours)
Title
Percentage of time with plasma glucose concentration above 11.0 mmol/L
Time Frame
Overall study period (4 hours)
Title
Percentage of time with plasma glucose concentration below 4.0 mmol/L
Time Frame
Overall study period (4 hours)
Title
Post-breakfast peak plasma glucose
Time Frame
1 hour after breakfast

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémi Rabasa-Lhoret, MD, PhD
Organizational Affiliation
IRCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Recherches Cliniques de Montréal (IRCM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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