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

26 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if when one eats protein can change how the body uses food for energy. Researchers will also test if eating a high protein breakfast can change one's craving for snack foods.

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.

What data supports the effectiveness of the treatment Even protein, Skewed protein for obesity management?

Research suggests that increasing protein intake can help preserve muscle mass and improve function during weight loss, especially in older adults. A study found that consuming about 30 grams of high-quality protein per meal may lead to better outcomes in terms of muscle mass and physical function compared to traditional weight loss methods. ^{1 2 3 4 5}

Is protein intake safe for humans in managing obesity?

Higher-protein diets have been shown to be generally safe and can help with weight management, reducing fat mass, and improving heart health factors like blood pressure and triglycerides. However, long-term effects are less clear, and sticking to the diet is important for seeing benefits. ^{2 6 7 8 9}

How does the treatment 'Protein Intake Patterns for Obesity Management' differ from other treatments for obesity?

This treatment focuses on adjusting protein intake patterns to manage obesity, which is unique because it leverages the 'protein leverage hypothesis'. This hypothesis suggests that a higher protein intake can help control appetite and energy intake, potentially leading to better weight management compared to traditional low-calorie or low-fat diets. ^{6 7 9 10 11}

Research Team

Shanon Casperson, PhD

Principal Investigator

USDA Grand Forks Human Nutrition Research Center

Eligibility Criteria

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

I am on medication that affects my energy levels or appetite.

I do not eat or use animal products.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Meal-based enhancement of protein quality and quantity during weight loss in obese older adults with mobility limitations: rationale and design for the MEASUR-UP trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Interactions of dietary protein and adiposity measures in relation to subsequent changes in body weight and waist circumference. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Lower protein in infant formula is associated with lower weight up to age 2 y: a randomized clinical trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Higher protein intake preserves lean mass and satiety with weight loss in pre-obese and obese women. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

[High-protein diets and obesity]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Early protein intake and later obesity risk: which protein sources at which time points throughout infancy and childhood are important for body mass index and body fat percentage at 7 y of age? [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The role of protein in weight loss and maintenance. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The potential impact of animal protein intake on global and abdominal obesity: evidence from the Observation of Cardiovascular Risk Factors in Luxembourg (ORISCAV-LUX) study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Longitudinal association between animal and vegetable protein intake and obesity among men in the United States: the Chicago Western Electric Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Testing protein leverage in lean humans: a randomised controlled experimental study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Dietary protein - its role in satiety, energetics, weight loss and health. [2022]