Protein Eating Patterns and Weight Loss

NCT ID: NCT03202069

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2023-04-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Even protein intake

Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.

Group Type EXPERIMENTAL

Even protein

Intervention Type OTHER

Intake of even protein 5 day rotating menu

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.

Group Type EXPERIMENTAL

Skewed protein

Intervention Type OTHER

Intake of skewed protein 5 day rotating menu

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Even protein

Intake of even protein 5 day rotating menu

Intervention Type OTHER

Skewed protein

Intake of skewed protein 5 day rotating menu

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

North Dakota Beef Commission

UNKNOWN

Sponsor Role collaborator

USDA Grand Forks Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shanon Casperson, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Grand Forks Human Nutrition Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

De Leon A, Roemmich JN, Casperson SL. Daily Dietary Protein Distribution Does Not Influence Changes in Body Composition During Weight Loss in Women of Reproductive Years with Overweight or Obesity: A Randomized Controlled Trial. J Nutr. 2024 Apr;154(4):1347-1355. doi: 10.1016/j.tjnut.2024.02.009. Epub 2024 Feb 15.

Reference Type DERIVED
PMID: 38365118 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/

Grand Forks Human Nutrition Research Center Current Nutrition Studies

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GFHNRC510

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Protein Intake & Insulin Action
NCT02004002 COMPLETED NA