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The Effects of Protein Source on Appetite Control, Satiety, and Subsequent Food Intake: A Clinical Screening Study

The Effects of Protein Source on Appetite Control, Satiety, and Subsequent Food Intake: A Clinical Screening Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03595436
Enrollment
40
Registered
2018-07-23
Start date
2018-06-01
Completion date
2019-03-30
Last updated
2019-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appetitive Behavior

Brief 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, 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.

Interventions

DIETARY_SUPPLEMENTPea Protein-20g

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.

DIETARY_SUPPLEMENTPea Protein-30g

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.

DIETARY_SUPPLEMENTPea Protein-40g

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.

DIETARY_SUPPLEMENTWhey Protein-20g

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.

DIETARY_SUPPLEMENTCarbohydrate Control

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.

Sponsors

Purdue University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Double-blind, placebo-controlled

Intervention model description

tightly-controlled, randomized crossover design

Eligibility

Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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 * 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Perceived Hunger-30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 minA 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-30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 minA 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-30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 minA 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-30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 minA 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 Intake5 testing days across ~ 2 monthsThe 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.

Secondary

MeasureTime frameDescription
Perceived Breakfast Preload Palatability5 testing days across ~ 2 monthsA 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026