Metabolic and Functional Impact of Various Breakfast Models

NCT ID: NCT03240757

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-14
• Study Completion Date: 2010-05-28

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.

Conditions

Metabolism and Nutrition Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Breakfast without exercise

Each subject of the same arm underwent 2 interventions: breakfast with/without exercise

Group Type: ACTIVE_COMPARATOR

Breakfast

Intervention Type: DIETARY_SUPPLEMENT

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.

Breakfast with exercise

Each subject of the same arm underwent 2 interventions: breakfast with/without exercise

Group Type: EXPERIMENTAL

Breakfast

Intervention Type: DIETARY_SUPPLEMENT

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.

exercise

Intervention Type: OTHER

aerobic exercise at 40% of VO2max, for 20 minutes

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

exercise

aerobic exercise at 40% of VO2max, for 20 minutes

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Milan

OTHER

Sponsor Role: collaborator

Ospedale San Donato

OTHER

Sponsor Role: lead

Responsible Party

Livio Luzi

M.D., Full Professor of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Livio Luzi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gruppo San Donato

References

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).

Reference Type: RESULT

Other Identifiers

Colazioni/1

Identifier Type: -

Identifier Source: org_study_id