Clinical trial NCT03202069: Protein Eating Patterns and Weight Loss
Official title: Effect of Daily Protein Intake Patterns During Weight Loss on Dietary Adherence and Body Composition in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Protein
Weight Loss
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: North Dakota Beef Commission
First posted: 2017-06-28
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the effects of daily protein intake patterns on body composition and eating behaviors during weight loss.

Detailed description: The reinforcing value of food varies greatly among individuals, but is strongest for those who are overweight or obese. Reducing energy intake, which is necessary for overweight and obese individuals to achieve a healthier body weight, increases the reinforcing value of food - especially for energy-dense snack foods. Food is a powerful reinforcer and is associated with energy intake; making it a primary contributing factor to an individual's weight loss struggle. Developing a way to decrease or limit the increase in food reinforcement during energy deficits would have important clinical impact. High-protein diets are known to be efficacious for weight loss and recently have been shown to decrease stimulation of the reward areas of the brain that stimulate reward-driven eating behavior. Nonetheless, sustaining a high-protein diet can be difficult, especially for women. Consuming a modest amount of protein at each meal may be better tolerated. However, we do not know whether this pattern of protein intake can assist women in staying "on track" with weight loss goals. This study will help begin to elucidate the connections between the daily pattern of protein intake on diet adherence, alterations in food reinforcement, and favorable body composition changes during weight loss.

Eligibility criteria: Inclusion Criteria:

* BMI 28-45 kg/m2

Exclusion Criteria:

* unable or unwilling to consume animal products
* unable or unwilling to attend treatment group meetings
* had more than a 10% change in body weight in the 2 months prior to study start date
* consuming a specialized diet
* have a history of and eating or gastrointestinal disorder
* currently or planning on becoming pregnant during the study timeline
* lactating
* have an uncontrolled metabolic illness/disease (fasting glucose \>125 mg/dL)
* have uncontrolled hypertension (\>160/99 mm Hg)
* have cancer or in short-term remission (less than 3 years)
* have an infectious disease
* suffer from alcohol or drug abuse
* use tobacco and/or e-cigarette products on a regular basis
* taking medications known to affect energy expenditure and appetite

Primary outcomes:
measure: Body Composition
timeFrame: 8 and 16 weeks
measure: Diet Adherence
timeFrame: 16 weeks
Secondary outcomes:
measure: Barriers to weight control
timeFrame: 1 hour
measure: Change in skeletal muscle protein breakdown
timeFrame: 8 and 16 weeks
measure: Circulating carotenoid levels
timeFrame: 8 and 16 weeks
measure: Relative reinforcing value (RRV) of food
timeFrame: 8 and 16 weeks
measure: Change in bone turnover
timeFrame: 8 and 16 weeks
measure: Plasma lipids
timeFrame: 8 and 16 weeks
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: