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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03399812
Other study ID # 1708038914
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2017
Est. completion date June 30, 2018

Study information

Verified date July 2018
Source University of Arkansas, Fayetteville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date June 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Male

- No medication

- Athlete (elite or professional)

Exclusion Criteria:

- Diet-related conditions

- Food allergies

- Does not regularly consume protein supplements

- Claustrophobic

- Underweight

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Animal protein
The animal protein intervention is a smoothie containing 40 grams of whey protein isolate.
Plant protein
The animal protein intervention is a smoothie containing 40 grams of pea protein isolate.

Locations

Country Name City State
United States University of Arkansas Fayetteville Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas, Fayetteville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Appetite biomarkers PYY, CCK and orexin will be measured. Time frame is every 30 minutes for four hours following intervention.
Primary Energy expenditure Energy expended per minute will be measured using indirect calorimetry. Time frame is every 30 minutes for four hours following intervention.
Primary Appetite 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. Time frame is every 30 minutes for four hours following intervention.
Secondary 24-hour food intake Food intake following the intervention will be recorded using food records. Food intake will be recorded for one day.
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