- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03301948
Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses
The Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses in Healthy Young Men
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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'.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Leeds, Royaume-Uni, LS6 3QS
- Leeds Beckett University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Overfeed
Experimental trial where participants are provided with 50% higher energy intake than their estimated requirements on the first day of the trial.
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Participants consume energy intakes that are 50% higher than their estimated requirements instead of consuming energy intakes equal to their estimated requirements
|
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Expérimental: Energy Balance
Experimental trial where participants are provided with an energy intake equal to their estimated requirements on the first day of the trial.
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Participants consume energy intakes equal to their estimated requirements instead of consuming intakes that are 50% higher than their estimated requirements
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Appetite perceptions assessed using 100mm visual analogue scales
Délai: 28 hours
|
Appetite perceptions using 100mm visual analogue scales
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28 hours
|
|
Ad libitum energy intake
Délai: 28 hours
|
Ad libitum energy intake using an ad libitum pasta meal
|
28 hours
|
|
Plasma acylated ghrelin concentrations
Délai: 28 hours
|
Measured using ELISA from venous blood samples
|
28 hours
|
|
Plasma peptide YY concentrations
Délai: 28 hours
|
Measured using ELISA from venous blood samples
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28 hours
|
|
Plasma GLP-1 concentrations
Délai: 28 hours
|
Measured using ELISA from venous blood samples
|
28 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Palatability perceptions assessed using 100mm visual analogue scales
Délai: 28 hours
|
Palatability of the test meals assessed via 100mm visual analogue scales during the first day of each trial
|
28 hours
|
|
Blinding assessment
Délai: 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
Délai: 28 hours
|
Measured using ELISA from venous blood samples
|
28 hours
|
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Plasma glucose concentrations
Délai: 28 hours
|
Measured using photometric analysis from venous blood samples
|
28 hours
|
|
Plasma triglyceride concentrations
Délai: 28 hours
|
Measured using photometric analysis from venous blood samples
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28 hours
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Kevin Deighton, PhD, Leeds Beckett University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 34693
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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