Protein Eating Patterns and Weight Loss

• ClinicalTrials.gov Identifier: NCT03202069
• Recruitment Status: Completed
• First Posted: June 28, 2017
• Last Update Posted: November 2, 2023
• Sponsor: USDA Grand Forks Human Nutrition Research Center
• Collaborator: North Dakota Beef Commission
• Information provided by (Responsible Party): Shanon Casperson, USDA Grand Forks Human Nutrition Research Center

Tracking Information

• First Submitted Date: June 26, 2017
• First Posted Date: June 28, 2017
• Last Update Posted Date: November 2, 2023
• Actual Study Start Date: October 2, 2017
• Actual Primary Completion Date: April 14, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 26, 2019)

• Body Composition [ Time Frame: 8 and 16 weeks ]
  Determine the effects of two patterns of daily protein intake on changes in fat mass and fat-free mass during weight loss.
• Diet Adherence [ Time Frame: 16 weeks ]
  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.

• Original Primary Outcome Measures (submitted: June 26, 2017): Postprandial lipid oxidation rate [ Time Frame: 4 hours after meal consumption ]

Current Secondary Outcome Measures (submitted: March 26, 2019)

• Barriers to weight control [ Time Frame: 1 hour ]
  Nominal Group Technique results providing an exhaustive list of barriers to weight control in overweight and obese women
• Change in skeletal muscle protein breakdown [ Time Frame: 8 and 16 weeks ]
  The effect of consuming two patterns of daily protein intake on 3-Methylhistidine degradation, a biochemcial marker of skeletal muscle protein breakdown
• Circulating carotenoid levels [ Time Frame: 8 and 16 weeks ]
  The effect of consuming two patterns of protein intake during weight loss on circulating carotenoid levels.
• Relative reinforcing value (RRV) of food [ Time Frame: 8 and 16 weeks ]
  The effect of consuming two patterns of daily protein intake during weight loss on the RRV of energy-dense snack food
• Change in bone turnover [ Time Frame: 8 and 16 weeks ]
  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
• Plasma lipids [ Time Frame: 8 and 16 weeks ]
  The effect of consuming two patterns of daily protein intake during weight loss on lipid and triglyceride molecular speciation.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Obesity

Intervention

• Other: Even protein
  Intake of even protein 5 day rotating menu
• Other: Skewed protein
  Intake of skewed protein 5 day rotating menu

Study Arms

• Experimental: Even protein intake
  Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.
  Intervention: Other: Even protein
• 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.
  Intervention: Other: Skewed protein

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 2, 2023): 45
• Original Estimated Enrollment (submitted: June 26, 2017): 46
• Actual Study Completion Date: April 14, 2023
• Actual Primary Completion Date: April 14, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 44 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03202069
• Other Study ID Numbers: GFHNRC510
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Shanon Casperson, USDA Grand Forks Human Nutrition Research Center
• Original Responsible Party: Same as current
• Current Study Sponsor: USDA Grand Forks Human Nutrition Research Center
• Original Study Sponsor: Same as current
• Collaborators: North Dakota Beef Commission

Investigators

• Principal Investigator: Shanon Casperson, PhD; USDA Grand Forks Human Nutrition Research Center

• PRS Account: USDA Grand Forks Human Nutrition Research Center
• Verification Date: October 2023