The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults

NCT03031132 | Suspended DMC

• 1 other identifier: 2005823 HS
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of breakfast skipping (SKIP) vs. the consumption of a high protein solid (HP-S) breakfast vs. the consumption of a high protein beverage (HP-B) breakfast on daily appetite control, food cravings, food intake, and sleep quality in young adults.

Conditions

Appetite and General Nutritional Disorders

Keywords

Protein-rich breakfast; Breakfast Skipping; Young Adults; Breakfast; Food form; fMRI; Ghrelin; PYY; Sleep

Outcome Measures

Primary Outcomes (5)

• Hunger

  Questionnaires, assessing appetite sensations of hunger will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."

  4 weeks

• Fullness

  Questionnaires, assessing appetite sensations of fullness will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."

  4 weeks

• Prospective Food Consumption

  Questionnaires, assessing appetite sensations of prospective food consumption will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."

  4 weeks

• Motivation to Eat

  Questionnaires, assessing appetite sensations of motivation to eat will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."

  4 weeks

• Hedonic Ratings (pleasure)

  Questionnaires, assessing appetite sensations of hedonic pleasure will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."

  4 weeks

Secondary Outcomes (14)

• Objective Sleep Status - Total Sleep Time

  4 weeks

• Objective Sleep Quality

  4 weeks

• Objective Sleep Efficiency

  4 weeks

• Objective Sleep and Circadian Patterns - Salivary Cortisol

  4 weeks

• Objective Sleep and Circadian Patterns - Salivary Melatonin

  4 weeks

Study Arms (3)

HP-Beverage Breakfast

EXPERIMENTAL

For 7 days, the participants will consume high protein beverage breakfast meals each morning. These meals will consist of shakes and will be 350 kcal. The macronutrient composition of these meals will contain 30 g of dietary protein, 35g CHO, and 10g fat. The HP-S and HP-B meals will be matched for energy density, sugar content, macronutrient content and types of proteins.

Behavioral: HP-Beverage Breakfast

HP-Solid Breakfast

EXPERIMENTAL

For 7 days, the participants will consume high protein solid breakfast meals each morning. These meals will consist of traditional solid breakfast meals and will include commonly consumed breakfast foods (e.g., burritos, waffles, etc.) and will be 350 kcal. The macronutrient composition of these meals will contain 30 g of dietary protein, 35 g CHO, and 10 g fat. The HP-S and HP-B meals will be matched for energy density, sugar content, macronutrient content and types of proteins.

Behavioral: HP-Solid Breakfast

Breakfast Skipping

EXPERIMENTAL

For 7 days, the participants will skip the morning meal. No food or calorie-containing beverages will be consumed before 12pm on acclimation days and no food consumed until \~5h post habitual breakfast time on testing day 7.

Behavioral: Breakfast Skipping

Interventions

HP-Beverage Breakfast BEHAVIORAL

Participants will consume high protein beverage (shake) breakfast meals each morning.

HP-Beverage Breakfast

HP-Solid Breakfast BEHAVIORAL

Participants will consume high protein solid (traditional food items) breakfast meals each morning.

HP-Solid Breakfast

Breakfast Skipping BEHAVIORAL

Participants will skip breakfast each morning.

Breakfast Skipping

Eligibility Criteria

• Age: 20 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 20-32y
• BMI 22-30kg/m2
• non-smoker, non-user of tobacco products
• generally healthy (as assessed by Medical History Questionnaire)
• right-handed (fMRI requirement)
• not pregnant or lactating in the past 6 months
• not clinically diagnosed with and eating disorder
• no metabolic, hormonal, and/or neural conditions/diseases/medications that influence metabolism or food intake
• no known bleeding disorders
• not currently or previously (In the past 6 months) on a weight loss or other special diet
• no weight loss/gain (\>10lbs) in the past 6 months
• normal cognitive restraint, as assessed by a score of \<4 on the Three Factors Eating Habits Questionnaire (TFEQ)
• rating of ≥ 5 illustrating a minimum of "neither like nor dislike" on a 9-point hedonic scale rating for the study breakfasts
• not clinically diagnosed with obstructive sleep apnea or insomnia and does not participate in shiftwork

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

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MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Heather J Leidy, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 25, 2017
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)