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Cystic FibrosisSNACK_CFNCT03710538

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

A study testing Snack beverage and Exercise in people with Cystic Fibrosis, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cystic Fibrosis
What is being tested?
Snack beverage and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteCanada
Study dates
1 Apr 2019to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of cystic fibrosis,
  • Be over 18 years old.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Institut de Recherches Cliniques de Montréal (IRCM)

    Montreal, Quebec, H2W 1R7

Other trials in Canada

About this study

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.

Read the 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
Being tested
Snack beverage, Exercise
Keywords
glycemia
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Snack beverageDietary supplement

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

  • ExerciseBehavioural

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

Study groups in NCT03710538
Study groupRoleWhat they receive
[Placebo + Sedentary]No intervention1) 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]Experimental2) Consumption of 200ml of soy beverage + 90g of carbohydrate (CHO) breakfast for men and 80g for women; Sedentary activities throughout the study
Receives: Dietary Supplement: Snack beverage
[Placebo + Exercise]Experimental3) 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);
Receives: Behavioral: Exercise
[Snack + Exercise]Experimental4) 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).
Receives: Dietary Supplement: Snack beverage; Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total area under the curve for plasma glucose

    Measured: Overall study period (4 hours)

Secondary outcomes (12)

  1. Area under the curve for plasma glucose

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

  2. Area under the curve for plasma glucose

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

  3. Total area under the curve for insulin

    Measured: Overall study period (4 hours)

  4. Area under the curve for insulin

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

  5. Area under the curve for insulin

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

  6. Mean plasma glucose

    Measured: Overall study period (4 hours)

  7. Mean insulin

    Measured: Overall study period (4 hours)

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

    Measured: Overall study period (4 hours)

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

    Measured: Overall study period (4 hours)

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

    Measured: Overall study period (4 hours)

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

    Measured: Overall study period (4 hours)

  12. Post-breakfast peak plasma glucose

    Measured: 1 hour after breakfast

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2018
  2. Study start1 Apr 2019
  3. Primary completion26 May 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model 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 \[condition control\] 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). \[Combined snack and exercise effect on the PPG excursion\]
Masking
Single blind
Who is masked
Participant
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03710538
Sponsor's protocol ID
SNACK_CF
Acronym
SNACK_CF
Status last verified
Apr 2023
First submitted
20 Jun 2018
Last updated
25 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bonhoure A, Colomba J, Boudreau V, Coriati A, Parent V, Devaux M, Bouchard D, Lavoie A, Rabasa-Lhoret R. The effect of a pre-meal snack and/or postprandial exercise on breakfast glycemic excursion in adults with cystic fibrosis: A pilot study. Clin Nutr ESPEN. 2024 Oct;63:952-958. doi: 10.1016/j.clnesp.2024.08.016. Epub 2024 Aug 24.

    PubMed 39187012

Questions about this trial

What is this clinical trial studying?

A study testing Snack beverage and Exercise in people with Cystic Fibrosis, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total area under the curve for plasma glucose (time frame: Overall study period (4 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03710538, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.

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