Clinical trial NCT03154606: The Effects of Protein Source on Appetite Control, Satiety, and Subsequent Food Intake
Official title: The Effects of Protein Source on Appetite Control, Satiety, and Subsequent Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: tightly-controlled, randomized cross-over design
Primary purpose: PREVENTION

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. postprandial feelings of hunger, fullness, desire to eat, prospective food consumption
2. postprandial fluctuations in key appetite and satiety hormones
3. eating initiation (i.e., motivation to eat (again))
4. food cravings

Aim 2: To examine whether the consumption of protein-rich meals that vary in protein quality (source) effect:

1. energy intake and food choice within the breakfast meal
2. energy intake and food choice at the next eating occasion
3. 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).

Eligibility criteria: Inclusion Criteria:

* 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

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 ≥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

Primary outcomes:
measure: Appetite Sensations of Hunger
timeFrame: 12 testing days across ~6 months
measure: Appetite Sensations of Fullness
timeFrame: 12 testing days across ~6 months
measure: Appetite Sensations of Desire to Eat
timeFrame: 12 testing days across ~6 months
measure: Appetite Sensations of Prospective Food Consumption
timeFrame: 12 testing days across ~6 months
Secondary outcomes:
measure: Perceived Food Cravings: Sweet
timeFrame: 12 testing days across ~6 months
measure: Perceived Food Cravings: Salty
timeFrame: 12 testing days across ~6 months
measure: Perceived Food Cravings: Savory-fat
timeFrame: 12 testing days across ~6 months
measure: Perceived Food Cravings: Meat
timeFrame: 12 testing days across ~6 months
measure: Perceived Breakfast Palatability
timeFrame: 12 testing days across ~6 months
measure: Perceived Energy: Sleepiness
timeFrame: 12 testing days across ~6 months
measure: Perceived Energy: Energy
timeFrame: 12 testing days across ~6 months
measure: Perceived Energy: Alertness
timeFrame: 12 testing days across ~6 months
measure: Food Cravings Inventory
timeFrame: 12 testing days across ~6 months
measure: Hormonal Response to Interventions: Plasma Ghrelin
timeFrame: 12 testing days across ~6 months
measure: Hormonal Response to Interventions: Plasma PYY
timeFrame: 12 testing days across ~6 months
measure: Hormonal Response to Interventions: Plasma GLP-1
timeFrame: 12 testing days across ~6 months
measure: 24-h Energy Intake Dietary Recalls
timeFrame: 12 testing days across ~6 months
measure: Ad Libitum Breakfast
timeFrame: 12 testing days across ~6 months
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Heather J Leidy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.