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Metabolic DiseaseNCT03301948

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

A study testing Overfeed and Energy Balance in people with Metabolic Disease and Appetitive Behavior, run by Leeds Beckett University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Metabolic Disease, Appetitive Behavior
What is being tested?
Overfeed and Energy Balance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
1 May 2017to 11 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • weight stable
  • healthy

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Leeds Beckett University

    Leeds, LS6 3QS

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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'.

Being tested
Overfeed, Energy Balance
Medical subject headings
Metabolic Diseases, Appetitive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OverfeedOther

    Participants consume energy intakes that are 50% higher than their estimated requirements instead of consuming energy intakes equal to their estimated requirements

  • Energy BalanceOther

    Participants consume energy intakes equal to their estimated requirements instead of consuming intakes that are 50% higher than their estimated requirements

Study groups in NCT03301948
Study groupRoleWhat they receive
OverfeedExperimentalExperimental trial where participants are provided with 50% higher energy intake than their estimated requirements on the first day of the trial.
Receives: Other: Overfeed
Energy BalanceExperimentalExperimental trial where participants are provided with an energy intake equal to their estimated requirements on the first day of the trial.
Receives: Other: Energy Balance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Appetite perceptions assessed using 100mm visual analogue scales

    Appetite perceptions using 100mm visual analogue scales

    Measured: 28 hours

  2. Ad libitum energy intake

    Ad libitum energy intake using an ad libitum pasta meal

    Measured: 28 hours

  3. Plasma acylated ghrelin concentrations

    Measured using ELISA from venous blood samples

    Measured: 28 hours

  4. Plasma peptide YY concentrations

    Measured using ELISA from venous blood samples

    Measured: 28 hours

  5. Plasma GLP-1 concentrations

    Measured using ELISA from venous blood samples

    Measured: 28 hours

Secondary outcomes (5)
  1. 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

    Measured: 28 hours

  2. 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.

    Measured: One week

  3. Plasma insulin concentrations

    Measured using ELISA from venous blood samples

    Measured: 28 hours

  4. Plasma glucose concentrations

    Measured using photometric analysis from venous blood samples

    Measured: 28 hours

  5. Plasma triglyceride concentrations

    Measured using photometric analysis from venous blood samples

    Measured: 28 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2017
  2. Study start1 May 2017
  3. Primary completion11 Jan 2019
  4. Study completion11 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Single blind, counterbalanced, crossover trial
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03301948
Sponsor's protocol ID
34693
Status last verified
Jan 2019
First submitted
8 Aug 2017
Last updated
14 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Overfeed and Energy Balance in people with Metabolic Disease and Appetitive Behavior, run by Leeds Beckett University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Appetite perceptions assessed using 100mm visual analogue scales (time frame: 28 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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