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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [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 |
|
| [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); |
|
| [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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Snack beverage | Dietary Supplement | Consumption of a 200ml of soy beverage (100Kcal, 11g CHO, 6g proteins, 4g fat) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total area under the curve for plasma glucose | Overall study period (4 hours) |
| Measure | Description | 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) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rémi Rabasa-Lhoret, MD, PhD | IRCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Recherches Cliniques de Montréal (IRCM) | Montreal | Quebec | H2W 1R7 | Canada |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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snack beverage or flavored placebo will be not recognizable
| Exercise | Behavioral | 3min walk at 60% VO2max every 30 minutes,(x5) |
|
| 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 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |