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Protein Eating Patterns and Weight Loss

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03202069
Enrollment
45
Registered
2017-06-28
Start date
2017-10-02
Completion date
2023-04-14
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Protein, Weight Loss

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.

Interventions

Intake of even protein 5 day rotating menu

Intake of skewed protein 5 day rotating menu

Sponsors

North Dakota Beef Commission
CollaboratorUNKNOWN
USDA Grand Forks Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 44 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Body Composition8 and 16 weeksDetermine the effects of two patterns of daily protein intake on changes in fat mass and fat-free mass during weight loss.
Diet Adherence16 weeksDetermine 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

MeasureTime frameDescription
Circulating carotenoid levels8 and 16 weeksThe effect of consuming two patterns of protein intake during weight loss on circulating carotenoid levels.
Relative reinforcing value (RRV) of food8 and 16 weeksThe effect of consuming two patterns of daily protein intake during weight loss on the RRV of energy-dense snack food
Barriers to weight control1 hourNominal Group Technique results providing an exhaustive list of barriers to weight control in overweight and obese women
Plasma lipids8 and 16 weeksThe effect of consuming two patterns of daily protein intake during weight loss on lipid and triglyceride molecular speciation.
Change in bone turnover8 and 16 weeksThe 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
Change in skeletal muscle protein breakdown8 and 16 weeksThe effect of consuming two patterns of daily protein intake on 3-Methylhistidine degradation, a biochemcial marker of skeletal muscle protein breakdown

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026