Appetitive BehaviorNCT03154606
The Effects of Protein Source on Appetite Control, Satiety, and Subsequent Food Intake
A study testing Micellar Casein (#1), Micellar Casein (#2) and Calcium Caseinate in people with Appetitive Behavior, run by Purdue University at 1 site in United States.
Trial summary
The investigators propose a randomized, tightly-controlled breakfast trial in normal to overweight adults that will test whether the consumption of various types of protein-rich meals, containing ~24g of protein, will differentially alter food intake and meal initiation through proposed appetite and satiety… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Micellar Casein (#1), Micellar Casein (#2) and Calcium Caseinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2017to 27 Jul 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females
- All ethnicities
- Age: 20-40y
- BMI/BMI Percentile: 18.5-29.9 kg/m2
- Consumes breakfast (>110 kcal prior to 10 am) at least 5 days/week for the past year
- Never smoked or used other tobacco products
Show all 10Show fewer
- Willing to consume the study breakfasts
- Generally healthy (as assessed by Medical History Questionnaire)
- Health conscious as determined by answering yes to 3 pre-screening health \& lifestyle questions
- Rating of ≥ 5 illustrating a minimum of "neither like nor dislike on a hedonic 9 pt taste test of all testing treatments
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 ≥4.5kg over the past 6 months
- Donated (or plan to donate) blood through the American Red Cross within the past 6 months (or future 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
- Clinically diagnosed with a sleeping disorder
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose a randomized, tightly-controlled breakfast trial in normal to overweight adults that will test whether the consumption of various types of protein-rich meals, containing ~24g of protein, will differentially alter food intake and meal initiation through proposed appetite and satiety mechanisms.
Aim 1: To examine whether the consumption of protein-rich meals that vary in protein quality (source) effect:
Read more
- postprandial feelings of hunger, fullness, desire to eat, prospective food consumption
- postprandial fluctuations in key appetite and satiety hormones
- eating initiation (i.e., motivation to eat (again))
- food cravings
Aim 2: To examine whether the consumption of protein-rich meals that vary in protein quality (source) effect:
- energy intake and food choice within the breakfast meal
- energy intake and food choice at the next eating occasion
- energy intake and food choice across the entire day
Read the detailed description
Experimental Design: For 3 consecutive days/pattern, the participants will consume the respective treatment, at home, between 7-9 am and refrain from eating or drinking anything other than water until 12:00pm. On day 3, the participants will consume a standardized dinner at home the night before testing. On day 4, the participants will report to the research facility between 6-8 am to complete each 5-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 questionnaires (and/or blood samples) will be completed. At time +0 min, the respective breakfast treatment will be provided. Immediately following the first swallow of the breakfast meal, the participants will be given a questionnaire assessing the palatability. The participants will consume the breakfast within 20 min. After breakfast, the participants will continue to complete the questionnaires (and/or blood samples) every 30 min throughout the 5-h postprandial period. Throughout the day, the participants will also indicate if/when they would like to eat again. Regardless of the participants' meal timing request, at +240min post-breakfast, the participants will be provided with an ad libitum lunch. 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 across the previous day. Lastly, on day 5 (at home), the participants will be provided with their respective breakfast along with additional carbohydrate and/or fat foods. Once the treatment breakfast is consumed, the participants can select and consume as much of the additional foods as they wish to consume within the breakfast time period (30 minutes).
- Conditions
- Appetitive Behavior
- Being tested
- Micellar Casein (#1), Micellar Casein (#2), Calcium Caseinate, Sodium Caseinate, Milk Protein Isolate
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micellar Casein (#1)Other
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from micellar casein. All ingredients are GRAS listed and approved.
Micellar Casein (#2)Other
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from micellar casein. All ingredients are GRAS listed and approved.
Calcium CaseinateOther
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from calcium casein. All ingredients are GRAS listed and approved.
Sodium CaseinateOther
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from sodium caseinate. All ingredients are GRAS listed and approved.
Milk Protein IsolateOther
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from milk protein caseinate. All ingredients are GRAS listed and approved.
Pure Protein BlendOther
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from pure protein blend. All ingredients are GRAS listed and approved.
Whey Protein IsolateOther
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from whey protein blend. All ingredients are GRAS listed and approved.
Native Whey Protein IsolateOther
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from Native Whey Protein Isolate. All ingredients are GRAS listed and approved.
Soy ProteinOther
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from soy protein. All ingredients are GRAS listed and approved.
Pea ProteinOther
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from pea protein. All ingredients are GRAS listed and approved.
Native Whey: Micellar Casein (50:50) blendOther
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from native whey: micellar casein (50:50) blend. All ingredients are GRAS listed and approved.
Carbohydrate ControlOther
The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain predominantly carbohydrates as a control. All ingredients are GRAS listed and approved.
| Study group | Role | What they receive |
|---|---|---|
| HP-Beverage Breakfast | Experimental | The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will vary in protein source. All ingredients are GRAS listed and approved. All participants will complete all 12 interventions. Receives: Other: Micellar Casein (#1); Other: Micellar Casein (#2); Other: Calcium Caseinate; Other: Sodium Caseinate; Other: Milk Protein Isolate; Other: Pure Protein Blend; Other: Whey Protein Isolate; Other: Native Whey Protein Isolate; Other: Soy Protein; Other: Pea Protein; Other: Native Whey: Micellar Casein (50:50) blend |
| Carbohydrate Control | Active comparator | The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will primarily as carbohydrates as a control. All ingredients are GRAS listed and approved. All participants will complete all 12 interventions. Receives: Other: Carbohydrate Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite Sensations of Hunger
Questionnaires assessing the appetitive sensations of hunger will be completed at specific times throughout each of the the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Appetite Sensations of Fullness
Questionnaires assessing the appetitive sensations of fullness will be completed at specific times throughout each of the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Appetite Sensations of Desire to Eat
Questionnaires assessing the appetitive sensations of desire to eat will be completed at specific times throughout each of the the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Appetite Sensations of Prospective Food Consumption
Questionnaires assessing the appetitive sensations of prospective food consumption will be completed at specific times throughout each of the the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Secondary outcomes (14)
Perceived Food Cravings: Sweet
Questionnaires assessing the food cravings will be completed at specific times throughout each of the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Perceived Food Cravings: Salty
Questionnaires assessing the food cravings will be completed at specific times throughout each of the the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Perceived Food Cravings: Savory-fat
Questionnaires assessing the food cravings will be completed at specific times throughout each of the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Perceived Food Cravings: Meat
Questionnaires assessing the food cravings will be completed at specific times throughout the each of the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Perceived Breakfast Palatability
Questionnaires assessing the breakfast palatability will be completed at specific times throughout each of the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Perceived Energy: Sleepiness
Questionnaires assessing perceived sleepiness will be completed at specific times throughout each of the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Perceived Energy: Energy
Questionnaires assessing perceived energy will be completed at specific times throughout each of the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Perceived Energy: Alertness
Questionnaires assessing perceived alertness will be completed at specific times throughout each of the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Measured: 12 testing days across ~6 months
Food Cravings Inventory
Participants will fill out a Food Cravings Inventory (FCI) at 4-h post-breakfast on each testing day. The FCI is a reliable and valid self-report measure of general and specific food cravings including cravings for high fat foods, carbohydrates/starches, sweets, and fast food. The FCI defines a craving as an intense desire to consume a particular food (or food type) that is difficult to resist.
Measured: 12 testing days across ~6 months
Hormonal Response to Interventions: Plasma Ghrelin
Ten blood samples (4 ml/sample) will be collected throughout each of the the 4-h testing days. The samples will be collected in EDTA test tubes containing pefabloc SC and DPP-IV to reduce protein degradation. Within 10-min of collection, the samples will be centrifuged, and the plasma will be stored at -80°C for future analysis.
Measured: 12 testing days across ~6 months
Hormonal Response to Interventions: Plasma PYY
Ten blood samples (4 ml/sample) will be collected throughout each of the 4-h testing days. The samples will be collected in EDTA test tubes containing pefabloc SC and DPP-IV to reduce protein degradation. Within 10-min of collection, the samples will be centrifuged, and the plasma will be stored at -80°C for future analysis.
Measured: 12 testing days across ~6 months
Hormonal Response to Interventions: Plasma GLP-1
Ten blood samples (4 ml/sample) will be collected throughout each of the the 4-h testing days. The samples will be collected in EDTA test tubes containing pefabloc SC and DPP-IV to reduce protein degradation. Within 10-min of collection, the samples will be centrifuged, and the plasma will be stored at -80°C for future analysis.
Measured: 12 testing days across ~6 months
24-h Energy Intake Dietary Recalls
To assess the participant's total energy content, macronutrient content, macronutrient consumption, and meal patterning, all subjects will complete a dietary recall following each testing day. The study staff will contact the participant the day after each of the testing days and ask questions related to the quantity, type, brand, preparation, and timing of food consumed following the testing day. Total energy content and macronutrient composition will be calculated using nutrition software.
Measured: 12 testing days across ~6 months
Ad Libitum Breakfast
Free-living energy intake at breakfast will be assessed on day 5, of each testing period, through a meal-specific food packout . The participants will first consume the respective breakfast treatment. Additionally, the participants will be provided with an excess of macronutrient-specific foods to consume, ad libitum for the breakfast time period (30 minutes), after the required, respective breakfast treatment. All food items will be initially weighed and recorded. The participants will be instructed to return all uneaten foods as well as all wrappers and containers from consumed food. Any partially eaten, returned items will be weighed accordingly. Breakfast meal energy and macronutrient content will be assessed from these packouts.
Measured: 12 testing days across ~6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start21 Mar 2017
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 cross-over design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 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 J Leidy, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154606
- Sponsor's protocol ID
- 1701018659
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2017
- Last updated
- 2 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Griffith CA, Leidy HJ, Gwin JA. Indices of Sleep Health Are Associated With Timing and Duration of Eating in Young Adults. J Acad Nutr Diet. 2024 Aug;124(8):1051-1057. doi: 10.1016/j.jand.2024.04.016. Epub 2024 Apr 30.
PubMed 38697355Braden ML, Gwin JA, Leidy HJ. Protein Source Influences Acute Appetite and Satiety but Not Subsequent Food Intake in Healthy Adults. J Nutr. 2023 Jun;153(6):1825-1833. doi: 10.1016/j.tjnut.2023.04.001. Epub 2023 Apr 6.
PubMed 37030593Douglas SM, Leidy HJ. Novel Methodological Considerations Regarding the Use of Visual Analog Scale (VAS) Appetite Questionnaires in Tightly Controlled Feeding Trials. Curr Dev Nutr. 2019 May 2;3(6):nzz061. doi: 10.1093/cdn/nzz061. eCollection 2019 Jun.
PubMed 31206096
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
- ClinicalTrials.gov ID
- NCT03154606
- Acronym / sponsor ID
- 1701018659
- Conditions
- Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 16 May 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.
The investigators propose a randomized, tightly-controlled breakfast trial in normal to overweight adults that will test whether the consumption of various types of protein-rich meals, containing ~24g of protein, will differentially alter food intake and meal initiation through proposed appetite and satiety mechanisms.
Aim 1: To examine whether the consumption of protein-rich meals that vary in protein quality (source) effect:
- postprandial feelings of hunger, fullness, desire to eat, prospective food consumption
- postprandial fluctuations in key appetite and satiety hormones
- eating initiation (i.e., motivation to eat (again))
- food cravings
Aim 2: To examine whether the consumption of protein-rich meals that vary in protein quality (source) effect:
- energy intake and food choice within the breakfast meal
- energy intake and food choice at the next eating occasion
- energy intake and food choice across the entire day
Detailed description
Experimental Design: For 3 consecutive days/pattern, the participants will consume the respective treatment, at home, between 7-9 am and refrain from eating or drinking anything other than water until 12:00pm. On day 3, the participants will consume a standardized dinner at home the night before testing. On day 4, the participants will report to the research facility between 6-8 am to complete each 5-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 questionnaires (and/or blood samples) will be completed. At time +0 min, the respective breakfast treatment will be provided. Immediately following the first swallow of the breakfast meal, the participants will be given a questionnaire assessing the palatability. The participants will consume the breakfast within 20 min. After breakfast, the participants will continue to complete the questionnaires (and/or blood samples) every 30 min throughout the 5-h postprandial period. Throughout the day, the participants will also indicate if/when they would like to eat again. Regardless of the participants' meal timing request, at +240min post-breakfast, the participants will be provided with an ad libitum lunch. 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 across the previous day. Lastly, on day 5 (at home), the participants will be provided with their respective breakfast along with additional carbohydrate and/or fat foods. Once the treatment breakfast is consumed, the participants can select and consume as much of the additional foods as they wish to consume within the breakfast time period (30 minutes).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- tightly-controlled, randomized cross-over design
| Arm | Type | Receives |
|---|---|---|
| HP-Beverage Breakfast | Experimental | Other: Micellar Casein (#1), Other: Micellar Casein (#2), Other: Calcium Caseinate, Other: Sodium Caseinate, Other: Milk Protein Isolate, Other: Pure Protein Blend, Other: Whey Protein Isolate, Other: Native Whey Protein Isolate, Other: Soy Protein, Other: Pea Protein, Other: Native Whey: Micellar Casein (50:50) blendThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will vary in protein source. All ingredients are GRAS listed and approved. All participants will complete all 12 interventions. |
| Carbohydrate Control | Active comparator | Other: Carbohydrate ControlThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will primarily as carbohydrates as a control. All ingredients are GRAS listed and approved. All participants will complete all 12 interventions. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males and females
- All ethnicities
- Age: 20-40y
- BMI/BMI Percentile: 18.5-29.9 kg/m2
- Consumes breakfast (>110 kcal prior to 10 am) at least 5 days/week for the past year
Key exclusion criteria (8 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 ≥4.5kg over the past 6 months
- Donated (or plan to donate) blood through the American Red Cross within the past 6 months (or future 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 |
|---|---|---|
| Micellar Casein (#1)The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from micellar casein. All ingredients are GRAS listed and approved. | Other | HP-Beverage Breakfast |
| Micellar Casein (#2)The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from micellar casein. All ingredients are GRAS listed and approved. | Other | HP-Beverage Breakfast |
| Calcium CaseinateThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from calcium casein. All ingredients are GRAS listed and approved. | Other | HP-Beverage Breakfast |
| Sodium CaseinateThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from sodium caseinate. All ingredients are GRAS listed and approved. | Other | HP-Beverage Breakfast |
| Milk Protein IsolateThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from milk protein caseinate. All ingredients are GRAS listed and approved. | Other | HP-Beverage Breakfast |
| Pure Protein BlendThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from pure protein blend. All ingredients are GRAS listed and approved. | Other | HP-Beverage Breakfast |
| Whey Protein IsolateThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from whey protein blend. All ingredients are GRAS listed and approved. | Other | HP-Beverage Breakfast |
| Native Whey Protein IsolateThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from Native Whey Protein Isolate. All ingredients are GRAS listed and approved. | Other | HP-Beverage Breakfast |
| Soy ProteinThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from soy protein. All ingredients are GRAS listed and approved. | Other | HP-Beverage Breakfast |
| Pea ProteinThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from pea protein. All ingredients are GRAS listed and approved. | Other | HP-Beverage Breakfast |
| Native Whey: Micellar Casein (50:50) blendThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from native whey: micellar casein (50:50) blend. All ingredients are GRAS listed and approved. | Other | HP-Beverage Breakfast |
| Carbohydrate ControlThe study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain predominantly carbohydrates as a control. All ingredients are GRAS listed and approved. | Other | Carbohydrate Control |
Primary outcome
Appetite Sensations of Hunger
Time frame: 12 testing days across ~6 months
Questionnaires assessing the appetitive sensations of hunger will be completed at specific times throughout each of the the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Appetite Sensations of Fullness
Time frame: 12 testing days across ~6 months
Questionnaires assessing the appetitive sensations of fullness will be completed at specific times throughout each of the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Appetite Sensations of Desire to Eat
Time frame: 12 testing days across ~6 months
Questionnaires assessing the appetitive sensations of desire to eat will be completed at specific times throughout each of the the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
Appetite Sensations of Prospective Food Consumption
Time frame: 12 testing days across ~6 months
Questionnaires assessing the appetitive sensations of prospective food consumption will be completed at specific times throughout each of the the 4-h testing days. The questionnaires contain 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." A summation (area under the curve) will be calculated.
14 secondary outcomes
Perceived Food Cravings: Sweet
Time frame: 12 testing days across ~6 months
Perceived Food Cravings: Salty
Time frame: 12 testing days across ~6 months
Perceived Food Cravings: Savory-fat
Time frame: 12 testing days across ~6 months
Perceived Food Cravings: Meat
Time frame: 12 testing days across ~6 months
Perceived Breakfast Palatability
Time frame: 12 testing days across ~6 months
Perceived Energy: Sleepiness
Time frame: 12 testing days across ~6 months
Perceived Energy: Energy
Time frame: 12 testing days across ~6 months
Perceived Energy: Alertness
Time frame: 12 testing days across ~6 months
Food Cravings Inventory
Time frame: 12 testing days across ~6 months
Hormonal Response to Interventions: Plasma Ghrelin
Time frame: 12 testing days across ~6 months
Hormonal Response to Interventions: Plasma PYY
Time frame: 12 testing days across ~6 months
Hormonal Response to Interventions: Plasma GLP-1
Time frame: 12 testing days across ~6 months
24-h Energy Intake Dietary Recalls
Time frame: 12 testing days across ~6 months
Ad Libitum Breakfast
Time frame: 12 testing days across ~6 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.
- Derived from this study: PubMed 38697355Griffith CA, Leidy HJ, Gwin JA. Indices of Sleep Health Are Associated With Timing and Duration of Eating in Young Adults. J Acad Nutr Diet. 2024 Aug;124(8):1051-1057. doi: 10.1016/j.jand.2024.04.016. Epub 2024 Apr 30.
- Derived from this study: PubMed 37030593Braden ML, Gwin JA, Leidy HJ. Protein Source Influences Acute Appetite and Satiety but Not Subsequent Food Intake in Healthy Adults. J Nutr. 2023 Jun;153(6):1825-1833. doi: 10.1016/j.tjnut.2023.04.001. Epub 2023 Apr 6.
- Derived from this study: PubMed 31206096Douglas SM, Leidy HJ. Novel Methodological Considerations Regarding the Use of Visual Analog Scale (VAS) Appetite Questionnaires in Tightly Controlled Feeding Trials. Curr Dev Nutr. 2019 May 2;3(6):nzz061. doi: 10.1093/cdn/nzz061. eCollection 2019 Jun.
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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 J Leidy, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micellar Casein (#1), Micellar Casein (#2) and Calcium Caseinate 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 10 inclusion and 8 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. 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?
Appetite Sensations of Hunger (time frame: 12 testing days across ~6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03154606, which also lists 3 linked publications.
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.