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Completed

NCT Number: NCT03399812

Breakfast and Metabolism in Men

This study will determine the short-term postprandial effects of protein source at breakfast on energy metabolism, markers of metabolic health, appetite, and food intake and young and older men.

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Key information

Conditions

Aging

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • No medication
  • Athlete (elite or professional)

Exclusion criteria

  • Diet-related conditions
  • Food allergies
  • Does not regularly consume protein supplements
  • Claustrophobic
  • Underweight

Treatment and study plan

Animal protein

Dietary Supplement

The animal protein intervention is a smoothie containing 40 grams of whey protein isolate.

Plant protein

Dietary Supplement

The animal protein intervention is a smoothie containing 40 grams of pea protein isolate.

Primary outcomes

  1. Energy expenditure

    Time frame: Time frame is every 30 minutes for four hours following intervention.

    Energy expended per minute will be measured using indirect calorimetry.

  2. Appetite

    Time frame: Time frame is every 30 minutes for four hours following intervention.

    Appetite will be assessed using a traditional 100-mm visual analog scale (VAS) (3) with opposing anchors (e.g., "extremely hungry" or "not hungry at all") at time points 15, 30, 60, 90, 120, 180 and 240 min. Questions consisted of: "how hungry do you feel at this moment", "how full do you feel at this moment", "how strong is your desire to eat this moment" and "how much food do you think you can eat at this moment." Participants were asked to place an "X" on the 100-mm VAS in the place that pertained to their perceived appetite feelings at each time point." Participants were asked to place an "X" on the 100-mm VAS in the place that pertained to their perceived appetite feelings at each time point. The averages for each time point are taken to represent the feeling of appetitive at a particular time point.

Secondary outcomes

  1. 24-hour food intake

    Time frame: Food intake will be recorded for one day.

    Food intake following the intervention will be recorded using food records.

Other outcomes

  1. Appetite biomarkers

    Time frame: Time frame is every 30 minutes for four hours following intervention.

    PYY, CCK and orexin will be measured.

Sponsors and collaborators

Lead sponsor

University of Arkansas, Fayetteville

Other

Registry information

Official study title

The Effect of Breakfast on Energy Metabolism, Appetite, and Food Intake in Men

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2018
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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