- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03132376
Effects of Consuming Protein Shakes, Varying in Protein Source, on Appetite, Satiety and Energy Intake
Study Overview
Status
Conditions
Detailed Description
the following acute, randomized crossover study will be completed in 12 healthy adults (age 18-35y; BMI: 18-29.9 kg/m2) to compare 135 kcal protein beverages consumed at breakfast containing 30 g of protein from whey isolate (WY), casein (CS), egg white isolate (EWI), egg white protein concentrate (EWP), or a 0 kcal water beverage - which serves as the control (CON). Note: the W beverage will be consumed on 2 different days; these days only differ by the postprandial outcomes completed (see below).
The participants will report to the research facility between 7 - 9 am to complete each 4-h testing day. Prior to testing, the participants will be provided with a standardized dinner to consume, at home, between 5-7 pm the night before each testing day. Upon arrival to the facility, each participant will become familiarized with the testing day procedures. At time -15 min, a baseline set of computerized questionnaires will be completed. At time 0 min, one of the breakfast beverages will be provided. Immediately following the first swallow of the breakfast shakes, the participants will be given a questionnaire assessing the palatability of each shake. The participants will consume the beverage within 20 min. For 5 of the 6 days, a set of questionnaires will be completed every 30 min throughout the 4-h postprandial period. For one of the W days, no questionnaires will be completed. After the 4-h, the participants will be given an ad libitum pasta meal to assess energy intake. For the lunch meal, the participants will be given 30 min to "consume as much or as little as possible until comfortably full." Following these procedures, the participants will be allowed to leave the facility. The next day, a dietary recall will be performed to assess daily energy intake following the consumption of the previous day's breakfast beverage.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Breakfast Preload Drink
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 |
Participants were given 275 ml (0 kcal) water to consume in the morning following an overnight fast.
This served as the control drink.
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.
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Hunger
Time Frame: 2 months
|
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
Time Frame: 2 months
|
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
Time Frame: 2 months
|
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
Time Frame: 2 months
|
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
Time Frame: 2 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily Food Intake
Time Frame: 2 months
|
The day following each testing day, a dietary recall was completed to determine daily energy and macronutrient content.
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MU2005830
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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