Clinical trial NCT02795442: Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack
Official title: Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2016-06-10
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if when one eats protein can change how the body uses food for energy. Researchers will also test if eating a high protein breakfast can change one's craving for snack foods.

Detailed description: The purpose of this study is to determine if consuming 30 g of high-quality protein at each meal can increase fat utilization and shift between-meal snack choices. While the benefits of high-protein diets are well known, little is known about the optimal amount of protein that should be eaten at each meal. Most Americans eat little protein at breakfast and lunch and most of their protein at the evening meal. Current guidelines for protein are based on body weight; however, recent evidence indicates that absolute amounts of protein at each meal are needed to maintain metabolically active fat-free mass. This suggests that a more even protein consumption pattern across daily meals may positively influence energy metabolism. In addition, recent evidence indicates that protein may reduce activity in the food reward areas of the brain. This suggests that protein may influence between-meal snacking by decreasing the relative reinforcing value (RRV) of highly rewarding snack foods. The RRV of a food is an empirical measure of its motivating value and energy-dense foods are highly reinforcing, especially for obese individuals. This study will be the first to investigate the role of the daily distribution of protein intake on energy metabolism and modifying snacking behavior.

Eligibility criteria: Inclusion Criteria:

* BMI \< 25 kg/m2
* BMI ≥ 30 kg/m2 but \< 34.5 kg/m2
* able to understand and sign the informed consent
* able to provide own transportation to the Center
* free of any major illness/disease
* usual protein intake within the acceptable macronutrient distribution range (10 to 30%)
* constant habitual activity patterns within the last 3 months
* females of childbearing age must be on birth control for a minimum of 3 months prior to study start and have regular menstrual cycles

Exclusion Criteria:

* unable or unwilling to consume animal products
* have had more than a 10% change in body weight within the past 2 months
* are participating in a weight loss diet/exercise program
* are consuming a specialized diet
* currently or planning on becoming pregnant during the study timeline
* lactating
* have a metabolic illness/disease
* have uncontrolled hypertension
* have ever had cancer
* have an infectious disease
* suffer from alcohol or drug abuse
* use tobacco and e-cigarette products on a regular basis
* have the presence of acute illness
* taking medications known to affect energy expenditure and appetite

Primary outcomes:
measure: Fat, carbohydrate, and protein utilization
timeFrame: 4 hours after meal consumption
measure: Relative reinforcing value (RRV) of energy-dense snack foods
timeFrame: 2 hours after breakfast consumption
Secondary outcomes:
measure: Peripheral neurotransmitter metabolites
timeFrame: 2 hours
measure: Psychoactive Effect Questionnaire
timeFrame: 2 hours
measure: Satiety visual analog scales
timeFrame: 4 hours after meal consumption
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Shanon Casperson, PhD
role: PRINCIPAL_INVESTIGATOR
References: