Appetitive BehaviorNCT03595436
The Effects of Protein Source on Appetite Control, Satiety, and Subsequent Food Intake: A Clinical Screening Study
A study testing Pea Protein-20g, Pea Protein-30g and Pea Protein-40g in people with Appetitive Behavior, run by Purdue University at 1 site in United States.
Trial summary
Primary Objective: To examine whether the consumption of preloads varying in protein quality effect subsequent meal energy and macronutrient content Secondary Objectives: To examine whether the consumption of preloads varying in protein quality effect postprandial feelings of hunger, fullness, desire to eat… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Pea Protein-20g, Pea Protein-30g and Pea Protein-40g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 30 Mar 2019
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal weight (BMI: 18.0-24.5 kg/m2)
- No history of smoking
- No metabolic or hormonal conditions/diseases that influence metabolism, appetite, or food intake
- No past history of surgical interventions for the treatment of obesity
- No weight loss/gain (≥10 lb. in the past 6 months)
- No medication that would influence directly appetite or cognition
Show all 18Show fewer
- No change in any medications (over the past 3 months)
- Not currently/previously on a special diet such as Atkins/Ketogenic, high protein, vegan, vegetarian, etc.
- Habitually consumes breakfast (i.e., of at least 350 kcal on ≥ 5 days/wk prior to 9 am
- Habitually consumes lunch (i.e., of at least 350 kcal on ≥ 5 days/wk approximately 4 h after breakfast
- Not clinically diagnosed with an eating disorder such as anorexia, bulimia, night-eating syndrome
- Displays a score of <4 on the Three Factor Eating Habits Questionnaire (TFEQ)
- No allergies and/or aversions to the food/ingredients included within the study
- No history of drug or alcohol abuse (i.e., >14 drinks/week)
- Willing to maintain current activity dietary patterns throughout the study
- Willing to consume all study breakfast and lunch foods
- Generally healthy, as assessed from the medical history questionnaire
- Rating of ≥ 5 illustrating a minimum of "neither like nor dislike on a hedonic 9 pt taste test of the breakfast preloads
Who cannot join
- Clinically diagnosed with an eating disorder
- Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
- Currently or previously on a weight loss or other special diet (in the past 6 months)
- Gained/lost >10 lb. over the past 6 months
- Taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months)
- Not willing or able to complete all study testing procedures
Trial locations and contacts
1 site in 1 country.
About this study
Primary Objective: To examine whether the consumption of preloads varying in protein quality effect subsequent meal energy and macronutrient content
Secondary Objectives: To examine whether the consumption of preloads varying in protein quality effect postprandial feelings of hunger, fullness, desire to eat, prospective food consumption, and eating initiation.
Exploratory Objective: To examine whether the consumption of preloads varying in protein quality effect postprandial cognitive performance.
Read the detailed description
The investigators propose the following acute, randomized crossover study to compare 5, isocaloric yogurt-based preloads containing 20, 30, or 40 g pea protein; 20 g whey protein; and an isocaloric carbohydrate (control).
For 3 consecutive days/pattern, the participants will consume the respective treatment, at home, between 7-9 am, based on their habitual breakfast time. (These days are implemented to allow for the acclimation to the respective preload. Using this approach, the participant becomes familiar with the taste profile along with the practice of consuming a breakfast 'shake' so that the testing day more closely assimilates the habitual effects of the preload on appetite, satiety, and food intake.)
On day 4, the participants will report to the research facility 1 h prior to their habitual breakfast time to complete each 4-h 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 appetite/satiety and cognitive function questionnaires will be completed. At time 0 min, the respective preload will be provided. Immediately following the first swallow of the preload, the participants will be given a questionnaire assessing the palatability. The participants will consume the preload within 10 min. Afterwards, the participants will continue to complete the questionnaires every 30 min throughout the 4-h postprandial period. In addition to these questionnaires, participants will complete a cognitive function paradigm at -30 min, +90 min, and +180 minutes in order to assess memory, executive function, attention, and reaction time. Throughout the day, the participants will also indicate if/when they would like to eat again. Regardless of their meal timing request, at 4-h post-breakfast, lunch will be provided. The participants will be given 30 min to "consume as much or as little as they wish until comfortably full." Following these procedures, the participants will be allowed to leave the facility. There will be a 3-7 day washout period between testing days.
- Conditions
- Appetitive Behavior
- Being tested
- Pea Protein-20g, Pea Protein-30g, Pea Protein-40g, Whey Protein-20g, Carbohydrate Control
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pea Protein-20gDietary supplement
The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 20 g pea protein, 5 g mixed protein (from yogurt and peanut-butter), 40 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast.
Pea Protein-30gDietary supplement
The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 30 g pea protein, 5 g mixed protein (from yogurt and peanut-butter), 32 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast.
Pea Protein-40gDietary supplement
The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 40 g pea protein, 5 g mixed protein (from yogurt and peanut-butter), 24 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast.
Whey Protein-20gDietary supplement
The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 20 g whey protein, 5 g mixed protein (from yogurt and peanut-butter), 40 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast.
Carbohydrate ControlDietary supplement
The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 5 g mixed protein (from yogurt and peanut-butter), 59 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Pea Protein Breakfast Preload | Experimental | The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preloads will be standardized to ~325 kcal. The preloads will include the same fat content but will vary in protein and carbohydrate amounts. All ingredients are GRAS listed and approved. Receives: Dietary Supplement: Pea Protein-20g; Dietary Supplement: Pea Protein-30g; Dietary Supplement: Pea Protein-40g |
| Carbohydrate Control Breakfast Preload | Placebo comparator | The study participants will be provided with a control breakfast preload to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. The preload will include the same fat content (as the Experimental Preloads) but will vary in protein and carbohydrate amounts. All ingredients are GRAS listed and approved. Receives: Dietary Supplement: Carbohydrate Control |
| Whey Protein | Active comparator | The study participants will be provided with an active control breakfast preload to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. The preload will include the same fat content (as the Experimental Preloads) but will vary in protein amount and type and carbohydrate amount. All ingredients are GRAS listed and approved. Receives: Dietary Supplement: Whey Protein-20g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Hunger
A questionnaire assessing perceived hunger will be completed at specific times throughout each of the the 4-h testing days. The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The range is 0 mm (min hunger) and 100 is max (hunger). A summation (area under the curve) will be calculated.
Measured: -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min
Perceived Fullness
A questionnaire assessing perceived fullness will be completed at specific times throughout each of the the 4-h testing days. The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The range is 0 mm (min) to 100 (max). A summation (area under the curve) will be calculated.
Measured: -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min
Perceived Desire to Eat
A questionnaire assessing perceived desire to eat will be completed at specific times throughout each of the the 4-h testing days. The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The range is 0 mm (min) to 100 (max). A summation (area under the curve) will be calculated.
Measured: -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min
Perceived Prospective Food Consumption
A questionnaire assessing how much could be consumed will be completed at specific times throughout each of the the 4-h testing days. The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The range is 0 mm (min) to 100 (max). A summation (area under the curve) will be calculated.
Measured: -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min
Lunch Energy Intake
The participants will be provided with an ad libitum pizza lunch to consume ad libitum. The amount of pizza provided (in grams) will be weight prior to consumption and any remains will be re-weighted after consumption. Energy consumed will be calculated.
Measured: 5 testing days across ~ 2 months
Secondary outcomes (1)
Perceived Breakfast Preload Palatability
A questionnaire assessing how much the breakfast is liked will be completed after the breakfast is meal is started for each of the the 4-h testing days. The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The range is 0 mm (min) to 100 (max).
Measured: 5 testing days across ~ 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Jun 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- tightly-controlled, randomized crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Leidy, Purdue University
- Investigators
- Heather Leidy, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595436
- Sponsor's protocol ID
- 1711019935
- Status last verified
- Apr 2019
- First submitted
- 30 Jun 2018
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Protein Source on Appetite Control, Satiety, and Subsequent Food Intake: A Clinical Screening Study
- ClinicalTrials.gov ID
- NCT03595436
- Acronym / sponsor ID
- 1711019935
- Conditions
- Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 23 Jul 2018 (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.
Primary Objective: To examine whether the consumption of preloads varying in protein quality effect subsequent meal energy and macronutrient content
Secondary Objectives: To examine whether the consumption of preloads varying in protein quality effect postprandial feelings of hunger, fullness, desire to eat, prospective food consumption, and eating initiation.
Exploratory Objective: To examine whether the consumption of preloads varying in protein quality effect postprandial cognitive performance.
Detailed description
The investigators propose the following acute, randomized crossover study to compare 5, isocaloric yogurt-based preloads containing 20, 30, or 40 g pea protein; 20 g whey protein; and an isocaloric carbohydrate (control).
For 3 consecutive days/pattern, the participants will consume the respective treatment, at home, between 7-9 am, based on their habitual breakfast time. (These days are implemented to allow for the acclimation to the respective preload. Using this approach, the participant becomes familiar with the taste profile along with the practice of consuming a breakfast 'shake' so that the testing day more closely assimilates the habitual effects of the preload on appetite, satiety, and food intake.)
On day 4, the participants will report to the research facility 1 h prior to their habitual breakfast time to complete each 4-h 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 appetite/satiety and cognitive function questionnaires will be completed. At time 0 min, the respective preload will be provided. Immediately following the first swallow of the preload, the participants will be given a questionnaire assessing the palatability. The participants will consume the preload within 10 min. Afterwards, the participants will continue to complete the questionnaires every 30 min throughout the 4-h postprandial period. In addition to these questionnaires, participants will complete a cognitive function paradigm at -30 min, +90 min, and +180 minutes in order to assess memory, executive function, attention, and reaction time. Throughout the day, the participants will also indicate if/when they would like to eat again. Regardless of their meal timing request, at 4-h post-breakfast, lunch will be provided. The participants will be given 30 min to "consume as much or as little as they wish until comfortably full." Following these procedures, the participants will be allowed to leave the facility. There will be a 3-7 day washout period between testing days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- tightly-controlled, randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Pea Protein Breakfast Preload | Experimental | Dietary Supplement: Pea Protein-20g, Dietary Supplement: Pea Protein-30g, Dietary Supplement: Pea Protein-40gThe study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preloads will be standardized to ~325 kcal. The preloads will include the same fat content but will vary in protein and carbohydrate amounts. All ingredients are GRAS listed and approved. |
| Carbohydrate Control Breakfast Preload | Placebo comparator | Dietary Supplement: Carbohydrate ControlThe study participants will be provided with a control breakfast preload to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. The preload will include the same fat content (as the Experimental Preloads) but will vary in protein and carbohydrate amounts. All ingredients are GRAS listed and approved. |
| Whey Protein | Active comparator | Dietary Supplement: Whey Protein-20gThe study participants will be provided with an active control breakfast preload to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. The preload will include the same fat content (as the Experimental Preloads) but will vary in protein amount and type and carbohydrate amount. All ingredients are GRAS listed and approved. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Normal weight (BMI: 18.0-24.5 kg/m2)
- No history of smoking
- No metabolic or hormonal conditions/diseases that influence metabolism, appetite, or food intake
- No past history of surgical interventions for the treatment of obesity
- No weight loss/gain (≥10 lb. in the past 6 months)
Key exclusion criteria (6 listed)
- Clinically diagnosed with an eating disorder
- Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
- Currently or previously on a weight loss or other special diet (in the past 6 months)
- Gained/lost >10 lb. over the past 6 months
- Taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months)
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 |
|---|---|---|
| Pea Protein-20gThe study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 20 g pea protein, 5 g mixed protein (from yogurt and peanut-butter), 40 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast. | Dietary supplement | Pea Protein Breakfast Preload |
| Pea Protein-30gThe study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 30 g pea protein, 5 g mixed protein (from yogurt and peanut-butter), 32 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast. | Dietary supplement | Pea Protein Breakfast Preload |
| Pea Protein-40gThe study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 40 g pea protein, 5 g mixed protein (from yogurt and peanut-butter), 24 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast. | Dietary supplement | Pea Protein Breakfast Preload |
| Whey Protein-20gThe study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 20 g whey protein, 5 g mixed protein (from yogurt and peanut-butter), 40 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast. | Dietary supplement | Whey Protein |
| Carbohydrate ControlThe study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 5 g mixed protein (from yogurt and peanut-butter), 59 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast. | Dietary supplement | Carbohydrate Control Breakfast Preload |
Primary outcome
Perceived Hunger
Time frame: -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min
A questionnaire assessing perceived hunger will be completed at specific times throughout each of the the 4-h testing days. The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The range is 0 mm (min hunger) and 100 is max (hunger). A summation (area under the curve) will be calculated.
Perceived Fullness
Time frame: -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min
A questionnaire assessing perceived fullness will be completed at specific times throughout each of the the 4-h testing days. The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The range is 0 mm (min) to 100 (max). A summation (area under the curve) will be calculated.
Perceived Desire to Eat
Time frame: -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min
A questionnaire assessing perceived desire to eat will be completed at specific times throughout each of the the 4-h testing days. The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The range is 0 mm (min) to 100 (max). A summation (area under the curve) will be calculated.
Perceived Prospective Food Consumption
Time frame: -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min
A questionnaire assessing how much could be consumed will be completed at specific times throughout each of the the 4-h testing days. The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The range is 0 mm (min) to 100 (max). A summation (area under the curve) will be calculated.
Lunch Energy Intake
Time frame: 5 testing days across ~ 2 months
The participants will be provided with an ad libitum pizza lunch to consume ad libitum. The amount of pizza provided (in grams) will be weight prior to consumption and any remains will be re-weighted after consumption. Energy consumed will be calculated.
1 secondary outcome
Perceived Breakfast Preload Palatability
Time frame: 5 testing days across ~ 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 2 May 2019.
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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.
Heather Leidy, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pea Protein-20g, Pea Protein-30g and Pea Protein-40g in people with Appetitive Behavior, run by Purdue University at 1 site in United States.
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 18 inclusion and 6 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 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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: -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min). 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 2 May 2019.