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OpenTrials
Completed

NCT Number: NCT03202069

Protein Eating Patterns and Weight Loss

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

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Key information

Age range

20 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Even protein

Other

Intake of even protein 5 day rotating menu

Skewed protein

Other

Intake of skewed protein 5 day rotating menu

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Collaborators

  • North Dakota Beef Commission

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2017
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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