Clinical trial NCT03240757: Metabolic and Functional Impact of Various Breakfast Models
Official title: Metabolic Responses of a Single Bout of Low-intensity Exercise Following Mixed Meals in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism and Nutrition Disorder
Keywords: meal absorption
exercise
energy balance
lipolysis
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2017-08-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized-crossover in healthy subjects
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma glucose responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
timeFrame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
measure: Plasma insulin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
timeFrame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
measure: Plasma ghrelin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
timeFrame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
measure: Plasma free fatty acids (FFA) responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
timeFrame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gruppo San Donato
name: Livio Luzi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, 8-13 giugno 2017, San Diego, CA, USA. Diabetes 2017 Jun; 66 (Supplement 1).