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NCT Number: NCT03710538

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherches Cliniques de Montréal (IRCM)

Montreal, Quebec, H2W 1R7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Snack beverage

Dietary Supplement

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

Exercise

Behavioral

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

Primary outcomes

  1. Total area under the curve for plasma glucose

    Time frame: Overall study period (4 hours)

Secondary outcomes

  1. Area under the curve for plasma glucose

    Time frame: From start of study to breakfast time (1 hour)

  2. Area under the curve for plasma glucose

    Time frame: From time of breakfast to the end of the study (3 hours)

  3. Total area under the curve for insulin

    Time frame: Overall study period (4 hours)

  4. Area under the curve for insulin

    Time frame: From start of study to breakfast time (1 hour)

  5. Area under the curve for insulin

    Time frame: From breakfast time to the end of the study (3 hours)

  6. Mean plasma glucose

    Time frame: Overall study period (4 hours)

  7. Mean insulin

    Time frame: Overall study period (4 hours)

  8. Percentage of time with plasma glucose concentration above 8.0 mmol/L

    Time frame: Overall study period (4 hours)

  9. Percentage of time with plasma glucose concentration above 10.0 mmol/L

    Time frame: Overall study period (4 hours)

  10. Percentage of time with plasma glucose concentration above 11.0 mmol/L

    Time frame: Overall study period (4 hours)

  11. Percentage of time with plasma glucose concentration below 4.0 mmol/L

    Time frame: Overall study period (4 hours)

  12. Post-breakfast peak plasma glucose

    Time frame: 1 hour after breakfast

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Acronym: SNACK_CF

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2018
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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