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

NCT03595436 | Completed

• 1 other identifier: 1711019935
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetitive Behavior

Outcome Measures

Primary Outcomes (5)

• Perceived Hunger

  A 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.

  -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min

• Perceived Fullness

  A 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.

  -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min

• Perceived Desire to Eat

  A 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.

  -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min

• Perceived Prospective Food Consumption

  A 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.

  -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min

• Lunch Energy Intake

  The 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.

  5 testing days across ~ 2 months

Secondary Outcomes (1)

• Perceived Breakfast Preload Palatability

  5 testing days across ~ 2 months

Study Arms (3)

Pea Protein Breakfast Preload

EXPERIMENTAL

The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preloads will be standardized to \~325 kcal. The preloads will include the same fat content but will vary in protein and carbohydrate amounts. All ingredients are GRAS listed and approved.

Dietary Supplement: Pea Protein-20g; Dietary Supplement: Pea Protein-30g; Dietary Supplement: Pea Protein-40g

Carbohydrate Control Breakfast Preload

PLACEBO COMPARATOR

The study participants will be provided with a control breakfast preload to consume. The energy content of the breakfast preload will be standardized to \~325 kcal. The preload will include the same fat content (as the Experimental Preloads) but will vary in protein and carbohydrate amounts. All ingredients are GRAS listed and approved.

Dietary Supplement: Carbohydrate Control

Whey Protein

ACTIVE COMPARATOR

The study participants will be provided with an active control breakfast preload to consume. The energy content of the breakfast preload will be standardized to \~325 kcal. The preload will include the same fat content (as the Experimental Preloads) but will vary in protein amount and type and carbohydrate amount. All ingredients are GRAS listed and approved.

Dietary Supplement: Whey Protein-20g

Interventions

Pea Protein-20g DIETARY_SUPPLEMENT

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.

Pea Protein Breakfast Preload

Pea Protein-30g DIETARY_SUPPLEMENT

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.

Pea Protein Breakfast Preload

Pea Protein-40g DIETARY_SUPPLEMENT

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.

Pea Protein Breakfast Preload

Whey Protein-20g DIETARY_SUPPLEMENT

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.

Whey Protein

Carbohydrate Control DIETARY_SUPPLEMENT

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.

Carbohydrate Control Breakfast Preload

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 \>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

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Heather Leidy, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo-controlled
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: tightly-controlled, randomized crossover design

Study Record Dates

• First Submitted: June 30, 2018
• First Posted: July 23, 2018
• Study Start: June 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: May 2, 2019

Record last verified: 2019-04

Locations

US (1)