Protein Intake Patterns for Obesity Management

Overseen By Shanon Casperson, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: USDA Grand Forks Human Nutrition Research Center

Must not be taking: Energy, appetite medications

Disqualifiers: Metabolic illness, Cancer, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether the timing of protein intake affects energy use and if a high-protein breakfast can reduce snack cravings. Participants will follow one of two eating plans: one with protein spread evenly across meals (even protein) and the other with most protein at dinner (skewed protein). The study seeks individuals with a BMI (a measure of body fat) below 25 or between 30 and 34.5, who maintain stable eating and activity habits, and are free from major illnesses. As an unphased trial, it offers a unique opportunity to contribute to understanding dietary impacts on energy use and cravings.

Will I have to stop taking my current medications?

The trial requires that you do not take medications known to affect energy expenditure and appetite.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that changing the timing of protein intake might aid in weight and fat loss. Studies have found that distributing protein evenly across breakfast, lunch, and dinner can support weight loss on certain diets.

However, consuming most protein at dinner does not significantly impact muscle or body changes compared to spreading it out. This suggests that protein timing might not be crucial for altering body shape.

Importantly, both methods of protein consumption—spreading it out or concentrating it at dinner—have been studied and are generally safe, with no serious side effects reported. Both approaches are usually well-tolerated by individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Protein Intake Patterns for Obesity Management trial because it explores how the timing and distribution of protein intake could impact weight management. Unlike typical obesity treatments that often rely on medication or calorie restriction, this trial focuses on dietary patterns. The "Even protein" approach offers a balanced 30 grams of protein at each meal, while the "Skewed protein" option provides most of the protein at dinner. This trial could reveal if protein distribution throughout the day influences weight loss differently, offering a new angle for managing obesity through diet.

What evidence suggests that this trial's treatments could be effective for obesity management?

This trial will compare two protein intake patterns for obesity management: an even protein distribution and a skewed protein distribution. Studies have shown that spreading protein intake evenly throughout the day can aid in weight and fat loss. Research indicates that consuming about 30 grams of protein at each meal helps maintain muscle and can lead to a greater reduction in body mass index (BMI) and belly fat. In contrast, consuming most protein at dinner, as in the skewed protein arm of this trial, does not significantly change body composition during weight loss. Evidence suggests that distributing protein evenly across meals may be more effective for managing obesity and improving body shape. ^{1 2 3 4 6}

Who Is on the Research Team?

Shanon Casperson, PhD

Principal Investigator

USDA Grand Forks Human Nutrition Research Center

Are You a Good Fit for This Trial?

This trial is for adults with a BMI < 25 or between 30-34.5, who are generally healthy and have not had significant weight changes recently. Women of childbearing age must use birth control and have regular cycles. Participants should eat normal amounts of protein and maintain consistent activity levels.

Inclusion Criteria

I can arrange my own travel to the Center.

BMI < 25 kg/m2

Able to understand and sign the informed consent

Exclusion Criteria

Have had more than a 10% change in body weight within the past 2 months

Are participating in a weight loss diet/exercise program

Currently or planning on becoming pregnant during the study timeline

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume either an even or skewed distribution of protein across meals to assess effects on energy metabolism and snacking behavior

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Even protein
• Skewed protein

Trial Overview The study investigates how the timing of protein intake affects energy metabolism and the desire to snack. It compares two patterns: even distribution of protein throughout the day versus a high-protein breakfast with less at other meals.

How Is the Trial Designed?

Group I: Skewed protein Experimental Treatment 1 Intervention

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 II: Even protein Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

USDA Grand Forks Human Nutrition Research Center

Lead Sponsor

Trials

60

Recruited

5,300+

Published Research Related to This Trial

A high-protein diet (1.2 g/kg body weight) during weight loss and maintenance helps sustain satiety and energy expenditure while preserving fat-free mass, which is crucial for long-term weight management.

The review indicates that adequate protein intake can improve body composition and blood pressure without causing kidney issues in healthy individuals, making it a safe and effective strategy for combating obesity and metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary protein - its role in satiety, energetics, weight loss and health. Westerterp-Plantenga, MS., Lemmens, SG., Westerterp, KR.[2022]

Higher-protein diets (1.2 to 1.6 g protein per kg of body weight per day) have been shown to lead to greater weight loss, fat mass loss, and preservation of lean mass compared to lower-protein diets, based on several meta-analyses of short-term studies.

While short-term studies consistently show benefits of higher protein intake, longer-term studies yield mixed results, primarily due to dietary compliance; those who adhered to higher-protein diets experienced significant improvements in body weight and cardiometabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of protein in weight loss and maintenance. Leidy, HJ., Clifton, PM., Astrup, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8883440/

Transition to a more even distribution of daily protein intake ... Our results show that mealtime distribution of protein intake throughout the day was associated with improved weight and fat loss under hypocaloric diet ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022316624000956

Daily Dietary Protein Distribution Does Not Influence ... Consuming 90 g/d may be more acceptable and easier for women to maintain over time, and a more even protein consumption pattern may support a more efficient and ...

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1388986/full

Impacts of protein quantity and distribution on body ... The researchers concluded that “a more even pattern of protein intake was associated with a greater decline in BMI and abdominal fat”. In a ...

4. jn.nutrition.org jn.nutrition.org/article/S0022-3166(24)00095-6/pdf

Daily Dietary Protein Distribution Does Not Influence Changes ... A balanced protein distribution of 25–30 g per meal improves 24-h muscle protein synthesis, which may promote FFM maintenance and greater ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7539343/

Clinical Evidence and Mechanisms of High-Protein Diet ... Participants in the protein group showed 50% less weight regain compared with control-group participants. Weight regain constituted FFM in the protein-group ...

6. stacks.cdc.gov stacks.cdc.gov/view/cdc/114974

Transition to a more even distribution of daily protein intake ... Conclusion: Our results show that mealtime distribution of protein intake throughout the day was associated with improved weight and fat loss under hypocaloric ...