ObesityNCT03132376
Effects of Consuming Protein Shakes, Varying in Protein Source, on Appetite, Satiety and Energy Intake
A study testing Water Preload Drink, Whey Protein Isolate Drink and Micellar Casein Protein Drink in people with Obesity, run by Purdue University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Water Preload Drink, Whey Protein Isolate Drink and Micellar Casein Protein Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 9Show fewer
- not a vegetarian
- not pregnant
- non-smoker
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Water Preload Drink, Whey Protein Isolate Drink, Micellar Casein Protein Drink, Egg White Isolate Protein Drink, Egg White Concentrate Protein Drink
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Micellar Casein Protein DrinkDietary supplement
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.
Egg White Isolate Protein DrinkDietary supplement
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.
Egg White Concentrate Protein DrinkDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Water Preload Drink; Dietary Supplement: Whey Protein Isolate Drink; Dietary Supplement: Micellar Casein Protein Drink; Dietary Supplement: Egg White Isolate Protein Drink; Dietary Supplement: Egg White Concentrate Protein Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 months
Secondary outcomes (1)
Daily Food Intake
The day following each testing day, a dietary recall was completed to determine daily energy and macronutrient content.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study startJun 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Leidy, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132376
- Sponsor's protocol ID
- MU2005830
- Status last verified
- May 2017
- First submitted
- 19 Apr 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Consuming Protein Shakes, Varying in Protein Source, on Appetite, Satiety and Energy Intake
- ClinicalTrials.gov ID
- NCT03132376
- Acronym / sponsor ID
- MU2005830
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breakfast Preload Drink | Experimental | Dietary Supplement: Water Preload Drink, Dietary Supplement: Whey Protein Isolate Drink, Dietary Supplement: Micellar Casein Protein Drink, Dietary Supplement: Egg White Isolate Protein Drink, Dietary Supplement: Egg White Concentrate Protein DrinkParticipants 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water Preload DrinkParticipants were given 275 ml (0 kcal) water to consume in the morning following an overnight fast. This served as the control drink. | Dietary supplement | Breakfast Preload Drink |
| Whey Protein Isolate DrinkParticipants were given an isovolumetric (to the water), 160 kcal drink with 30 g whey protein to consume in the morning following an overnight fast. | Dietary supplement | Breakfast Preload Drink |
| Micellar Casein Protein DrinkParticipants were given an isovolumetric (to the water), 160 kcal drink with 30 g micellar casein to consume in the morning following an overnight fast. | Dietary supplement | Breakfast Preload Drink |
| Egg White Isolate Protein DrinkParticipants 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. | Dietary supplement | Breakfast Preload Drink |
| Egg White Concentrate Protein DrinkParticipants 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. | Dietary supplement | Breakfast Preload Drink |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Daily Food Intake
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Water Preload Drink, Whey Protein Isolate Drink and Micellar Casein Protein Drink in people with Obesity, run by Purdue University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Hunger (time frame: 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.