Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses

11 januari 2019 bijgewerkt door: Leeds Beckett University

The Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses in Healthy Young Men

Healthy male participants are recruited to observe potentially deleterious changes in appetite regulation and metabolic control. Participants will be provided with an energy intake representative of their daily requirements on the first day of one trial and will be provided with an additional 50% energy intake on the first day of another trial. Outcome variables will be assessed during the second day of each trial in response to a fixed mixed macronutrient meal tolerance test.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

All testing will take place within the Carnegie Research Institute, Leeds Beckett University. We will ask all the participants to visit on five occasions for the completion of a preliminary screening trial and two single-blind counterbalanced experimental trials which each require the participants to visit the laboratory on two consecutive days. The experimental trials will be separated by a minimum of one week.

Visit 1: Preliminary Screening:

Before an individual can take part in the experiment, they will need to undergo screening. Individuals will need to complete a Health Screen Questionnaire. Individuals will be excluded from the study if they are not currently in good health, have any condition that would alter their metabolism and/or have had significant medical problems in the past that may affect the outcomes of the study. Individuals will also be asked to be complete a Three-Factor Eating Questionnaire, to check that they are not restrained eaters, and an International Physical Activity Questionnaire (IPAQ) to ensure that all participants are either sedentary or moderately active. All individuals will be asked to confirm that they have been weight stable for at least six months before participating and that they are not currently dieting. Height, body mass and age will be collected to calculate the energy requirements for the main trials based on the Mifflin equation.

Visits 2, 3, 4 and 5: Experimental Trials:

The participants will be asked to record their food intakes and activity patterns during the three days prior to the first experimental test using a food and physical activity diary. They will then be instructed to repeat this diet and activity pattern prior to the second experimental trial. Participants will be required to arrive at the laboratory for all experimental trials after an overnight fast of at least 10 hours and having refrained from any strenuous activity for 48 hours, and alcohol and caffeine consumption in the previous 24 hours. Two hours before arriving at the laboratory on the day of the experimental trials, participants will be required to ingest 300 mL of water to standardise hydration levels for the trial.

During Day One of each experimental trial, participants will consume a porridge-based breakfast, soup- and pasta-based lunch, and rice-based evening meal under laboratory observation. The meals will contain macronutrient contents representative of current dietary recommendations of 50% carbohydrate, 15% protein and 35% fat. These meals have been selected to facilitate manipulation of the energy content, while matching the meals for appearance and palatability. During one trial, these meals will provide the calculated energy requirement for each individual based on the Mifflin equation and a physical activity factor of 1.4. The meals will be covertly manipulated to provide an additional 50% energy intake during the other trial. The provision of 150% of the estimated energy requirements for participants has been used in previous research for five day periods but will only be provided for a single day in the present study. Participants will be required to consume all of the diet during the standardised phase (i.e. either their daily energy requirements or the 50% overfeed) and will be blinded to the energy content of the trials. After the consumption of the evening meal (~6pm), participants will have fulfilled the requirements for day one and will be asked not to consume any food prior to returning to the laboratory between 7am and 9am the next morning.

On Day Two of each experimental trial day, participants will arrive at the laboratory after an overnight fast and an Introcan Safety Cannula will be placed into a vein in the anticubital space for regular venous blood sampling. Blood samples will be collected in the fasted state and every 30 min after consumption of a standardised breakfast for a period of three hours. After the collection of the final blood sample, the cannula will be removed and participants will be provided with an ad libitum pasta meal (50% carbohydrate, 15% protein, 35% fat) for the assessment of energy intake. Participants will consume ad libitum meals in isolation to prevent any social influences and will be instructed to eat until 'satisfied'.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

12

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 35 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria:

  • weight stable
  • healthy

Exclusion Criteria:

  • any personal history of cardiovascular or metabolic disease
  • smokers
  • currently dieting
  • taking any medication known to influence appetite or metabolic outcomes
  • highly active (IPAQ category 3)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Overfeed
Experimental trial where participants are provided with 50% higher energy intake than their estimated requirements on the first day of the trial.
Participants consume energy intakes that are 50% higher than their estimated requirements instead of consuming energy intakes equal to their estimated requirements
Experimenteel: Energy Balance
Experimental trial where participants are provided with an energy intake equal to their estimated requirements on the first day of the trial.
Participants consume energy intakes equal to their estimated requirements instead of consuming intakes that are 50% higher than their estimated requirements

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Appetite perceptions assessed using 100mm visual analogue scales
Tijdsspanne: 28 hours
Appetite perceptions using 100mm visual analogue scales
28 hours
Ad libitum energy intake
Tijdsspanne: 28 hours
Ad libitum energy intake using an ad libitum pasta meal
28 hours
Plasma acylated ghrelin concentrations
Tijdsspanne: 28 hours
Measured using ELISA from venous blood samples
28 hours
Plasma peptide YY concentrations
Tijdsspanne: 28 hours
Measured using ELISA from venous blood samples
28 hours
Plasma GLP-1 concentrations
Tijdsspanne: 28 hours
Measured using ELISA from venous blood samples
28 hours

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Palatability perceptions assessed using 100mm visual analogue scales
Tijdsspanne: 28 hours
Palatability of the test meals assessed via 100mm visual analogue scales during the first day of each trial
28 hours
Blinding assessment
Tijdsspanne: One week
To assess whether the blinding of dietary manipulation of the first day of each trial was successful. This will be assessed via an exit questionnaire which requires qualitative responses regarding any noticeable differences in the foods provided and what aspect of the food the participants thought had been manipulated during the trials.
One week
Plasma insulin concentrations
Tijdsspanne: 28 hours
Measured using ELISA from venous blood samples
28 hours
Plasma glucose concentrations
Tijdsspanne: 28 hours
Measured using photometric analysis from venous blood samples
28 hours
Plasma triglyceride concentrations
Tijdsspanne: 28 hours
Measured using photometric analysis from venous blood samples
28 hours

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Kevin Deighton, PhD, Leeds Beckett University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2017

Primaire voltooiing (Werkelijk)

11 januari 2019

Studie voltooiing (Werkelijk)

11 januari 2019

Studieregistratiedata

Eerst ingediend

8 augustus 2017

Eerst ingediend dat voldeed aan de QC-criteria

29 september 2017

Eerst geplaatst (Werkelijk)

4 oktober 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 januari 2019

Laatste update ingediend die voldeed aan QC-criteria

11 januari 2019

Laatst geverifieerd

1 januari 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 34693

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Stofwisselingsziekte

Abonneren