NCT03132376

Brief Summary

Background: Consistent data from acute, single preload studies demonstrate improvements in perceived appetite and satiety following the consumption of high-protein preloads compared to normal protein preloads. However, it is currently unclear as to whether protein quality (i.e., protein source) or the use of appetite questionnaires influences these outcomes. Objective: To examine whether the consumption of protein preloads (egg white isolate, whey isolate, micellar casein, and instant egg white) differentially modulate postprandial hunger, fullness, desire to eat, prospective food consumption, eating initiation, and subsequent food intake; and if the use of appetite questionnaires to assess perceived appetite and satiety affect subsequent energy intake. Methods: Twelve young adults (age: 22±1 y; BMI: 22.1±0.9 kg/m2) reported to the research facility between 7 - 9 am to complete each 4-h testing day. A set of questionnaires assessing perceived hunger, fullness, desire to eat, prospective food consumption were completed followed by the consumption of the 130 kcal beverage preloads, varying in protein source. A water preload was also included as a control. The same set of questionnaires along with the assessment of whether they would like to eat again were completed every 30 min throughout the 4-h postprandial period. On a separate day, all twelve young adults also completed a similar testing day except were not given questionnaires throughout the 4-h postprandial period. After the 4-h, the participants were given an ad libitum pasta meal to consume until 'comfortably full.' Results: The consumption of the protein preloads improved hunger, fullness, desire to eat, prospective food consumption and delayed the request to eat again vs. the control (water); however, no differences in appetite and satiety outcomes were observed between protein sources. No differences in energy content at the lunch meal were observed between any preloads. The use of questionnaires did not change energy consumed at the lunch meal. Conclusions: When comparing high-quality animal-based proteins consumed as a beverage preload, relatively no differences in markers of appetite control and satiety were detected, suggesting that protein quality has little impact on these outcomes when consuming 30g of protein. In addition, the use of questionnaires assessing perceived appetite and satiety do not impact subsequent energy intake.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

April 19, 2017

Last Update Submit

May 17, 2017

Conditions

Outcome Measures

Primary Outcomes (5)

  • Perceived Hunger

    During each testing day, computerized questionnaires assessing hunger will be completed prior to consuming the study breakfast beverages and every half hour afterwards until leaving the testing facility. The questions are worded as "how strong is your feeling of" with anchors of "not at all" to "extremely." Each questionnaire takes approximately 30 seconds to complete. There are 10 questionnaires per testing day. Each questionnaire was completed on a netbook computer as well as through an app on an ipod touch.

    2 months

  • Perceived Fullness

    During each testing day, computerized questionnaires assessing fullness will be completed prior to consuming the study breakfast beverages and every half hour afterwards until leaving the testing facility. The questions are worded as "how strong is your feeling of" with anchors of "not at all" to "extremely." Each questionnaire takes approximately 30 seconds to complete. There are 10 questionnaires per testing day. Each questionnaire was completed on a netbook computer as well as through an app on an ipod touch.

    2 months

  • Perceived Desire to Eat

    During each testing day, computerized questionnaires assessing desire to eat will be completed prior to consuming the study breakfast beverages and every half hour afterwards until leaving the testing facility. The questions are worded as "how strong is your feeling of" with anchors of "not at all" to "extremely." Each questionnaire takes approximately 30 seconds to complete. There are 10 questionnaires per testing day. Each questionnaire was completed on a netbook computer as well as through an app on an ipod touch.

    2 months

  • Perceived Prospective Food Consumption

    During each testing day, computerized questionnaires assessing how much food he/she can consume will be completed prior to consuming the study breakfast beverages and every half hour afterwards until leaving the testing facility. The questions are worded as "how strong is your feeling of" with anchors of "not at all" to "an extreme amount." Each questionnaire takes approximately 30 seconds to complete. There are 10 questionnaires per testing day. Each questionnaire was completed on a netbook computer as well as through an app on an ipod touch.

    2 months

  • Subsequent Meal Energy Intake

    During each testing day, 4 h after the protein shake, the participants received an ad libitum pasta lunch. They were asked to consume this within 30 min until feeling 'comfortably full.' Energy and macronutrient content will be determined.

    2 months

Secondary Outcomes (1)

  • Daily Food Intake

    2 months

Study Arms (1)

Breakfast Preload Drink

EXPERIMENTAL

Participants were given isovolumetric drinks, to consume in the morning after an overnight fast, followed by questionnaires asking throughout the day asking participants of their perceived hunger, fullness, desire to eat, and prospective food consumption, and if they would like to eat again. Four hours following consumption, they were given an ad libitum pasta meal to consume. The drinks consisted of the following: Water Preload Drink, Whey Protein Isolate Drink, Micellar Casein Protein Drink, Egg White Isolate Protein Drink, and Egg White Concentrate Protein Drink

Dietary Supplement: Water Preload DrinkDietary Supplement: Whey Protein Isolate DrinkDietary Supplement: Micellar Casein Protein DrinkDietary Supplement: Egg White Isolate Protein DrinkDietary Supplement: Egg White Concentrate Protein Drink

Interventions

Water Preload DrinkDIETARY_SUPPLEMENT

Participants were given 275 ml (0 kcal) water to consume in the morning following an overnight fast. This served as the control drink.

Breakfast Preload Drink
Whey Protein Isolate DrinkDIETARY_SUPPLEMENT

Participants were given an isovolumetric (to the water), 160 kcal drink with 30 g whey protein to consume in the morning following an overnight fast.

Breakfast Preload Drink

Participants were given an isovolumetric (to the water), 160 kcal drink with 30 g micellar casein to consume in the morning following an overnight fast.

Breakfast Preload Drink

Participants were given an isovolumetric (to the water), 160 kcal drink with 30 g egg white isolate protein to consume in the morning following an overnight fast.

Breakfast Preload Drink

Participants were given an isovolumetric (to the water), 160 kcal drink with 30 g egg white concentrate protein to consume in the morning following an overnight fast.

Breakfast Preload Drink

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • ages 18-35 years old
  • normal weight to overweight (BMI: 18.5-29.9 kg/m2)
  • no metabolic, psychological, or neurological diseases/conditions
  • weight stable (no weight loss/gain within the past 6 mo)
  • not currently on a weight loss or other special diet (in the past 6 mo)
  • not a vegetarian
  • not pregnant
  • non-smoker

You may not qualify if:

  • Unhealthy
  • ages \<18 or \>35 years old
  • underweight or obese (BMI: \<18.5 or \>29.9 kg/m2)
  • metabolic, psychological, or neurological diseases/conditions
  • not weight stable (weight loss/gain within the past 6 mo)
  • Currently on a weight loss or other special diet (in the past 6 mo)
  • A vegetarian; 8) pregnant; and 9) smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2017

First Posted

April 27, 2017

Study Start

June 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

May 19, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share