Protein Eating Patterns and Weight Loss

Effect of Daily Protein Intake Patterns During Weight Loss on Dietary Adherence and Body Composition in Women

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Even protein; Other: Skewed protein

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Grand Forks, North Dakota, United States, 58203
      • USDA Grand Forks Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Even protein intake; Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.	Other: Even protein; Intake of even protein 5 day rotating menu
Experimental: Skewed protein intake; Menu to provide 90 g of protein per day in a skewed distribution of 10 g at breakfast, 15 g at lunch and 65 g at dinner.	Other: Skewed protein; Intake of skewed protein 5 day rotating menu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition	Determine the effects of two patterns of daily protein intake on changes in fat mass and fat-free mass during weight loss.	8 and 16 weeks
Diet Adherence	Determine the effects of two patterns of daily protein intake on weight loss diet adherence and putative mediators (satisfaction, satiety, hunger, and reinforcing value of energy dense foods) of adherence.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to weight control	Nominal Group Technique results providing an exhaustive list of barriers to weight control in overweight and obese women	1 hour
Change in skeletal muscle protein breakdown	The effect of consuming two patterns of daily protein intake on 3-Methylhistidine degradation, a biochemcial marker of skeletal muscle protein breakdown	8 and 16 weeks
Circulating carotenoid levels	The effect of consuming two patterns of protein intake during weight loss on circulating carotenoid levels.	8 and 16 weeks
Relative reinforcing value (RRV) of food	The effect of consuming two patterns of daily protein intake during weight loss on the RRV of energy-dense snack food	8 and 16 weeks
Change in bone turnover	The effect of consuming two patterns of daily protein intake during weight loss on osteocalcin, alkaline phosphatase, acid phosphatase, and collagen cross-link molecules -- biochemical markers of bone formation and resorption	8 and 16 weeks
Plasma lipids	The effect of consuming two patterns of daily protein intake during weight loss on lipid and triglyceride molecular speciation.	8 and 16 weeks

Collaborators and Investigators

• Sponsor: USDA Grand Forks Human Nutrition Research Center
• Collaborators: North Dakota Beef Commission
• Investigators: Principal Investigator: Shanon Casperson, PhD, USDA Grand Forks Human Nutrition Research Center

Publications and helpful links

Helpful Links

• Grand Forks Human Nutrition Research Center Current Nutrition Studies

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): April 14, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Weight Loss; Protein
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: GFHNRC510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No