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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:
Aim 2: To examine whether the consumption of protein-rich meals that vary in protein quality (source) effect:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 12 testing days across ~6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather J Leidy, PhD | Purdue University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purdue University | West Lafayette | Indiana | 47907 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38697355 | Derived | 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. | |
| 37030593 | Derived | Braden 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. |
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tightly-controlled, randomized cross-over design
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Double-blind
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| 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 Caseinate | 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 calcium casein. All ingredients are GRAS listed and approved. |
|
| Sodium Caseinate | 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 sodium caseinate. All ingredients are GRAS listed and approved. |
|
| Milk Protein Isolate | 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 milk protein caseinate. All ingredients are GRAS listed and approved. |
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| Pure Protein Blend | 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 pure protein blend. All ingredients are GRAS listed and approved. |
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| Whey Protein Isolate | 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 whey protein blend. All ingredients are GRAS listed and approved. |
|
| Native Whey Protein Isolate | 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 Native Whey Protein Isolate. All ingredients are GRAS listed and approved. |
|
| Soy Protein | 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 soy protein. All ingredients are GRAS listed and approved. |
|
| Pea Protein | 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 pea protein. All ingredients are GRAS listed and approved. |
|
| Native Whey: Micellar Casein (50:50) blend | 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 native whey: micellar casein (50:50) blend. All ingredients are GRAS listed and approved. |
|
| Carbohydrate Control | 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 predominantly carbohydrates as a control. All ingredients are GRAS listed and approved. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 testing days across ~6 months |
| 31206096 | Derived | Douglas 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. |
| ID | Term |
|---|---|
| D001070 | Appetitive Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C484216 | calcium caseinate |
| D002364 | Caseins |
| D030262 | Soybean Proteins |
| D000078724 | Pea Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010750 | Phosphoproteins |
| D010940 | Plant Proteins |
| D014674 | Plant Proteins, Dietary |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |
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