Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses
Primary Purpose
Metabolic Disease, Appetitive Behavior
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Overfeed
Energy Balance
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Disease
Eligibility Criteria
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)
Sites / Locations
- Leeds Beckett University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Overfeed
Energy Balance
Arm Description
Experimental trial where participants are provided with 50% higher energy intake than their estimated requirements on the first day of the trial.
Experimental trial where participants are provided with an energy intake equal to their estimated requirements on the first day of the trial.
Outcomes
Primary Outcome Measures
Appetite perceptions assessed using 100mm visual analogue scales
Appetite perceptions using 100mm visual analogue scales
Ad libitum energy intake
Ad libitum energy intake using an ad libitum pasta meal
Plasma acylated ghrelin concentrations
Measured using ELISA from venous blood samples
Plasma peptide YY concentrations
Measured using ELISA from venous blood samples
Plasma GLP-1 concentrations
Measured using ELISA from venous blood samples
Secondary Outcome Measures
Palatability perceptions assessed using 100mm visual analogue scales
Palatability of the test meals assessed via 100mm visual analogue scales during the first day of each trial
Blinding assessment
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.
Plasma insulin concentrations
Measured using ELISA from venous blood samples
Plasma glucose concentrations
Measured using photometric analysis from venous blood samples
Plasma triglyceride concentrations
Measured using photometric analysis from venous blood samples
Full Information
NCT ID
NCT03301948
First Posted
August 8, 2017
Last Updated
January 11, 2019
Sponsor
Leeds Beckett University
1. Study Identification
Unique Protocol Identification Number
NCT03301948
Brief Title
Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses
Official Title
The Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses in Healthy Young Men
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
January 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Leeds Beckett University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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'.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease, Appetitive Behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single blind, counterbalanced, crossover trial
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Overfeed
Arm Type
Experimental
Arm Description
Experimental trial where participants are provided with 50% higher energy intake than their estimated requirements on the first day of the trial.
Arm Title
Energy Balance
Arm Type
Experimental
Arm Description
Experimental trial where participants are provided with an energy intake equal to their estimated requirements on the first day of the trial.
Intervention Type
Other
Intervention Name(s)
Overfeed
Intervention Description
Participants consume energy intakes that are 50% higher than their estimated requirements instead of consuming energy intakes equal to their estimated requirements
Intervention Type
Other
Intervention Name(s)
Energy Balance
Intervention Description
Participants consume energy intakes equal to their estimated requirements instead of consuming intakes that are 50% higher than their estimated requirements
Primary Outcome Measure Information:
Title
Appetite perceptions assessed using 100mm visual analogue scales
Description
Appetite perceptions using 100mm visual analogue scales
Time Frame
28 hours
Title
Ad libitum energy intake
Description
Ad libitum energy intake using an ad libitum pasta meal
Time Frame
28 hours
Title
Plasma acylated ghrelin concentrations
Description
Measured using ELISA from venous blood samples
Time Frame
28 hours
Title
Plasma peptide YY concentrations
Description
Measured using ELISA from venous blood samples
Time Frame
28 hours
Title
Plasma GLP-1 concentrations
Description
Measured using ELISA from venous blood samples
Time Frame
28 hours
Secondary Outcome Measure Information:
Title
Palatability perceptions assessed using 100mm visual analogue scales
Description
Palatability of the test meals assessed via 100mm visual analogue scales during the first day of each trial
Time Frame
28 hours
Title
Blinding assessment
Description
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.
Time Frame
One week
Title
Plasma insulin concentrations
Description
Measured using ELISA from venous blood samples
Time Frame
28 hours
Title
Plasma glucose concentrations
Description
Measured using photometric analysis from venous blood samples
Time Frame
28 hours
Title
Plasma triglyceride concentrations
Description
Measured using photometric analysis from venous blood samples
Time Frame
28 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Deighton, PhD
Organizational Affiliation
Leeds Beckett University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leeds Beckett University
City
Leeds
ZIP/Postal Code
LS6 3QS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses
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