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

NCT03301948 | Completed

• 1 other identifier: 34693
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Disease; Appetitive Behavior

Outcome Measures

Primary Outcomes (5)

• Appetite perceptions assessed using 100mm visual analogue scales

  Appetite perceptions using 100mm visual analogue scales

  28 hours

• Ad libitum energy intake

  Ad libitum energy intake using an ad libitum pasta meal

  28 hours

• Plasma acylated ghrelin concentrations

  Measured using ELISA from venous blood samples

  28 hours

• Plasma peptide YY concentrations

  Measured using ELISA from venous blood samples

  28 hours

• Plasma GLP-1 concentrations

  Measured using ELISA from venous blood samples

  28 hours

Secondary Outcomes (5)

• Palatability perceptions assessed using 100mm visual analogue scales

  28 hours

• Blinding assessment

  One week

• Plasma insulin concentrations

  28 hours

• Plasma glucose concentrations

  28 hours

• Plasma triglyceride concentrations

  28 hours

Study Arms (2)

Overfeed

EXPERIMENTAL

Experimental trial where participants are provided with 50% higher energy intake than their estimated requirements on the first day of the trial.

Other: Overfeed

Energy Balance

EXPERIMENTAL

Experimental trial where participants are provided with an energy intake equal to their estimated requirements on the first day of the trial.

Other: Energy Balance

Interventions

Overfeed OTHER

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

Overfeed

Energy Balance OTHER

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

Energy Balance

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• weight stable
• healthy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Leeds Beckett University: lead

Study Sites (1)

Leeds Beckett University

Leeds, LS6 3QS, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Diseases; Appetitive Behavior

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Behavior, Animal; Behavior

Study Officials

• Kevin Deighton, PhD

  Leeds Beckett University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind, counterbalanced, crossover trial

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: October 4, 2017
• Study Start: May 1, 2017
• Primary Completion: January 11, 2019
• Study Completion: January 11, 2019
• Last Updated: January 14, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)