- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03240757
Metabolic and Functional Impact of Various Breakfast Models
4. august 2017 opdateret af: Livio Luzi, Ospedale San Donato
Metabolic Responses of a Single Bout of Low-intensity Exercise Following Mixed Meals in Healthy Individuals
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
19
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Breakfast without exercise
Each subject of the same arm underwent 2 interventions: breakfast with/without exercise
|
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.
|
|
Eksperimentel: Breakfast with exercise
Each subject of the same arm underwent 2 interventions: breakfast with/without exercise
|
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.
aerobic exercise at 40% of VO2max, for 20 minutes
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Plasma glucose responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
Tidsramme: 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.
|
The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
|
|
Plasma insulin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
Tidsramme: 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.
|
The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
|
|
Plasma ghrelin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
Tidsramme: 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.
|
The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
|
|
Plasma free fatty acids (FFA) responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
Tidsramme: 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.
|
The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Livio Luzi, M.D., Gruppo San Donato
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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).
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. juli 2009
Primær færdiggørelse (Faktiske)
28. maj 2010
Studieafslutning (Faktiske)
28. maj 2010
Datoer for studieregistrering
Først indsendt
1. august 2017
Først indsendt, der opfyldte QC-kriterier
4. august 2017
Først opslået (Faktiske)
7. august 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Colazioni/1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
De-identified collective participant data for all outcome measures will be made available upon publication
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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