The Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses in Healthy Young Men
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Leeds Beckett University
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Appetite perceptions assessed using 100mm visual analogue scales
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •weight stable
Exclusion Criteria
- •any personal history of cardiovascular or metabolic disease
- •currently dieting
- •taking any medication known to influence appetite or metabolic outcomes
- •highly active (IPAQ category 3)
Arms & Interventions
Energy Balance
Experimental trial where participants are provided with an energy intake equal to their estimated requirements on the first day of the trial.
Intervention: Energy Balance (Other)
Overfeed
Experimental trial where participants are provided with 50% higher energy intake than their estimated requirements on the first day of the trial.
Intervention: Overfeed (Other)
Outcomes
Primary Outcomes
Appetite perceptions assessed using 100mm visual analogue scales
Time Frame: 28 hours
Appetite perceptions using 100mm visual analogue scales
Ad libitum energy intake
Time Frame: 28 hours
Ad libitum energy intake using an ad libitum pasta meal
Plasma acylated ghrelin concentrations
Time Frame: 28 hours
Measured using ELISA from venous blood samples
Plasma peptide YY concentrations
Time Frame: 28 hours
Measured using ELISA from venous blood samples
Plasma GLP-1 concentrations
Time Frame: 28 hours
Measured using ELISA from venous blood samples
Secondary Outcomes
- Palatability perceptions assessed using 100mm visual analogue scales(28 hours)
- Plasma glucose concentrations(28 hours)
- Blinding assessment(One week)
- Plasma insulin concentrations(28 hours)
- Plasma triglyceride concentrations(28 hours)