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Protein Eating Patterns and Weight Loss

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Other: Even protein Other: Skewed protein Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Daily Protein Intake Patterns During Weight Loss on Dietary Adherence and Body Composition in Women
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : April 14, 2023
Actual Study Completion Date : April 14, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202069


Locations
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United States, North Dakota
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58203
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
North Dakota Beef Commission
Investigators
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Principal Investigator: Shanon Casperson, PhD USDA Grand Forks Human Nutrition Research Center
  Study Documents (Full-Text)

Documents provided by Shanon Casperson, USDA Grand Forks Human Nutrition Research Center:
Informed Consent Form  [PDF] January 27, 2023

More Information
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Responsible Party: Shanon Casperson, PhD, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT03202069    
Other Study ID Numbers: GFHNRC510
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: November 2, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanon Casperson, USDA Grand Forks Human Nutrition Research Center:
Protein
Weight Loss
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight