ObesityNCT03202069
Protein Eating Patterns and Weight Loss
A study testing Even protein and Skewed protein in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Even protein and Skewed protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2017to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 28-45 kg/m2
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Effect of Daily Protein Intake Patterns During Weight Loss on Dietary Adherence and Body Composition in Women
The purpose of this study is to determine the effects of daily protein intake patterns on body composition and eating behaviors during weight loss.
Read the 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.
- Conditions
- Obesity
- Being tested
- Even protein, Skewed protein
- Keywords
- Protein, Weight Loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Even proteinOther
Intake of even protein 5 day rotating menu
Skewed proteinOther
Intake of skewed protein 5 day rotating menu
| Study group | Role | What they receive |
|---|---|---|
| Even protein intake | Experimental | Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal. Receives: Other: Even protein |
| Skewed protein intake | Experimental | 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. Receives: Other: Skewed protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Determine the effects of two patterns of daily protein intake on changes in fat mass and fat-free mass during weight loss.
Measured: 8 and 16 weeks
Diet Adherence
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.
Measured: 16 weeks
Secondary outcomes (6)
Barriers to weight control
Nominal Group Technique results providing an exhaustive list of barriers to weight control in overweight and obese women
Measured: 1 hour
Change in skeletal muscle protein breakdown
The effect of consuming two patterns of daily protein intake on 3-Methylhistidine degradation, a biochemcial marker of skeletal muscle protein breakdown
Measured: 8 and 16 weeks
Circulating carotenoid levels
The effect of consuming two patterns of protein intake during weight loss on circulating carotenoid levels.
Measured: 8 and 16 weeks
Relative reinforcing value (RRV) of food
The effect of consuming two patterns of daily protein intake during weight loss on the RRV of energy-dense snack food
Measured: 8 and 16 weeks
Change in bone turnover
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
Measured: 8 and 16 weeks
Plasma lipids
The effect of consuming two patterns of daily protein intake during weight loss on lipid and triglyceride molecular speciation.
Measured: 8 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start2 Oct 2017
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- North Dakota Beef Commission
- Responsible party
- Sponsor
- Investigators
- Shanon Casperson, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202069
- Sponsor's protocol ID
- GFHNRC510
- Status last verified
- Apr 2025
- First submitted
- 26 Jun 2017
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38365118
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Protein Intake Patterns During Weight Loss on Dietary Adherence and Body Composition in Women
- ClinicalTrials.gov ID
- NCT03202069
- Acronym / sponsor ID
- GFHNRC510
- Conditions
- Obesity
- Keywords
- Protein, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Collaborators
- North Dakota Beef Commission
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Even protein intake | Experimental | Other: Even proteinMenu to provide 90 g of protein per day in an even distribution of 30 g at each meal. |
| Skewed protein intake | Experimental | Other: Skewed proteinMenu 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. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 28-45 kg/m2
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Even proteinIntake of even protein 5 day rotating menu | Other | Even protein intake |
| Skewed proteinIntake of skewed protein 5 day rotating menu | Other | Skewed protein intake |
Primary outcome
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.
6 secondary outcomes
Barriers to weight control
Time frame: 1 hour
Change in skeletal muscle protein breakdown
Time frame: 8 and 16 weeks
Circulating carotenoid levels
Time frame: 8 and 16 weeks
Relative reinforcing value (RRV) of food
Time frame: 8 and 16 weeks
Change in bone turnover
Time frame: 8 and 16 weeks
Plasma lipids
Time frame: 8 and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Derived from this study: PubMed 38365118De 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.
- Grand Forks Human Nutrition Research Center Current Nutrition StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruitingPhase 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1/2
Investigating the Effects of 24 Hour LEAP2 Infusion in Individuals With Overweight and Obesity
Obesity & Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanon Casperson, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Even protein and Skewed protein in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: 8 and 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03202069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.