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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03240757
Other study ID # Colazioni/1
Secondary ID
Status Completed
Phase N/A
First received August 1, 2017
Last updated August 4, 2017
Start date July 14, 2009
Est. completion date May 28, 2010

Study information

Verified date August 2017
Source Ospedale San Donato
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the present study the investigators compared the hormonal and metabolic effects of three meal loads very popular among Italian eating habits, both in the resting- and exercising state. Given the lack of time is considered a common barrier to exercise adherence, we wanted to identify a low dose of exercise capable to produce health benefits in the post-absorptive status elicited by three commonly consumed meal-models in Mediterranean countries. To this end, healthy young volunteers firstly underwent an oral glucose tolerance test (OGTT) and three meal tolerance tests. Secondly, in an extra set of experiments, subjects cycled at low intensity for the last 20 minutes of the same glucose/meal tolerance test. Glycemia, insulinemia, ghrelinemia, lipidemia, and satiety were measured throughout OGTT and each test-meal load.


Description:

The investigators evaluated postprandial responses (glucose, insulin, ghrelin, free fatty acids (FFA)) elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise were investigated. All subjects underwent a 50-g OGTT (A) and 3 test-meal loads: milk and cereals (B1); milk, apple and chocolate cream-filled sponge cake (B2); milk, bread, apple and hazelnut chocolate cream (B3). In the exercise trial, participants cycled for 20 minutes at 40% VO2max, 100 minutes after load ingestion.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date May 28, 2010
Est. primary completion date May 28, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- age between 18 and 40 years

- normal body weight (BMI =18.5 - 24.9 according to NHLBI)

- stable diet

Exclusion Criteria:

- Diabetes, tipe 1 and 2 (ADA criteria)

- Glucose intolerance (ADA criteria)

- Dyslipidemia (ATP III according to NCEP)

- Metabolic syndrome

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Breakfast
All subjects received a standard 75-g OGTT to assess eligibility for the study. The 19 subjects matching the inclusion criteria completed 2 experimental trials: resting and exercise. During the resting trial, all subjects underwent an OGTT (50-g: A) and 3 meal tolerance tests [one for each breakfast tested: B1 = milk (125ml) and cereals (30g); B2 = milk (220ml), apple (200g) and chocolate cream-filled sponge cake (30g); B3 = milk (125ml), apple (150g), bread (50g) and hazelnut chocolate cream (15g)]. In the exercise trial, 100 minutes after the glucose/meal ingestion, participants cycled for 20 min at 40% of maximum oxygen uptake.
Other:
exercise
aerobic exercise at 40% of VO2max, for 20 minutes

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ospedale San Donato University of Milan

References & Publications (1)

R Codella, A Caumo, S Benedini, M Adamo, A Ferrulli, C Macrì, I Terruzzi, L Luzi. Metabolic responses of a single bout of low-intensity exercise following mixed meals in healthy individuals. ADA (American Diabetes Association) 77th Scientific Session, 8-1

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma glucose responses of a single bout of low-intensity exercise following mixed meals in healthy individuals. Postprandial glycemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise. The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
Primary Plasma insulin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals. Postprandial insulinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise. The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
Primary Plasma ghrelin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals. Postprandial ghrelinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise. The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
Primary Plasma free fatty acids (FFA) responses of a single bout of low-intensity exercise following mixed meals in healthy individuals. Postprandial plasma FFA responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise. The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
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