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Completed

NCT Number: NCT03240757

Metabolic and Functional Impact of Various Breakfast Models

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.

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Key information

Conditions

Metabolism and Nutrition Disorder Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Breakfast

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

Other

aerobic exercise at 40% of VO2max, for 20 minutes

Primary outcomes

  1. Plasma glucose responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.

    Time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).

    Postprandial glycemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.

  2. Plasma insulin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.

    Time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).

    Postprandial insulinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.

  3. Plasma ghrelin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.

    Time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).

    Postprandial ghrelinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.

  4. Plasma free fatty acids (FFA) responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.

    Time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).

    Postprandial plasma FFA responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.

Sponsors and collaborators

Lead sponsor

Ospedale San Donato

Other

Collaborators

  • University of Milan

Registry information

Official study title

Metabolic Responses of a Single Bout of Low-intensity Exercise Following Mixed Meals in Healthy Individuals

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 7, 2017
Registry last updated
Aug 7, 2017

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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