NCT03154606

Brief 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 mechanisms. Aim 1: To examine whether the consumption of protein-rich meals that vary in protein quality (source) effect:

  1. 1.postprandial feelings of hunger, fullness, desire to eat, prospective food consumption
  2. 2.postprandial fluctuations in key appetite and satiety hormones
  3. 3.eating initiation (i.e., motivation to eat (again))
  4. 4.food cravings
  5. 5.energy intake and food choice within the breakfast meal
  6. 6.energy intake and food choice at the next eating occasion
  7. 7.energy intake and food choice across the entire day

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2018

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

April 19, 2017

Last Update Submit

April 30, 2019

Conditions

Appetitive Behavior

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (14)

  • Perceived Food Cravings: Sweet

    12 testing days across ~6 months

  • Perceived Food Cravings: Salty

    12 testing days across ~6 months

  • Perceived Food Cravings: Savory-fat

    12 testing days across ~6 months

  • Perceived Food Cravings: Meat

    12 testing days across ~6 months

  • Perceived Breakfast Palatability

    12 testing days across ~6 months

  • +9 more secondary outcomes

Study Arms (2)

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.

Other: Micellar Casein (#1)Other: Micellar Casein (#2)Other: Calcium CaseinateOther: Sodium CaseinateOther: Milk Protein IsolateOther: Pure Protein BlendOther: Whey Protein IsolateOther: Native Whey Protein IsolateOther: Soy ProteinOther: Pea ProteinOther: 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.

Other: Carbohydrate Control

Interventions

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.

HP-Beverage Breakfast
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.

HP-Beverage Breakfast
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.

HP-Beverage Breakfast
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.

HP-Beverage Breakfast
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.

HP-Beverage Breakfast
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.

HP-Beverage Breakfast
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.

HP-Beverage Breakfast
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.

HP-Beverage Breakfast
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.

HP-Beverage Breakfast
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.

HP-Beverage Breakfast
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.

HP-Beverage Breakfast
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.

Carbohydrate Control

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (3)

  • 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.

    PMID: 38697355DERIVED

  • 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.

    PMID: 37030593DERIVED

  • 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.

    PMID: 31206096DERIVED

MeSH Terms

Conditions

Appetitive Behavior

Interventions

calcium caseinateCaseinsSoybean ProteinsPea Proteins

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPhosphoproteinsPlant ProteinsPlant Proteins, DietaryFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Officials

  • Heather J Leidy, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: tightly-controlled, randomized cross-over design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2017

First Posted

May 16, 2017

Study Start

March 21, 2017

Primary Completion

July 27, 2018

Study Completion

July 27, 2018

Last Updated

May 2, 2019

Record last verified: 2019-04

Locations

US(1)