75 Participants NeededMy employer runs this trial

Protein Rich Foods for Obesity

Recruiting at 1 trial location
HL
Overseen ByHeather Leidy, PhD, FASN
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Texas at Austin
Must be taking: GLP-1
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the impact of adding protein-rich foods on middle-aged women with obesity who are starting or have recently started GLP-1 medications, which help control blood sugar and appetite. One group of participants will continue their medication as usual, while another group will also consume protein-rich foods daily for 12 weeks. The study will measure changes in body composition, eating habits, health, and well-being. Women diagnosed with obesity and new to GLP-1 medication use might be suitable candidates. As an unphased trial, this study provides a unique opportunity to understand how dietary changes can enhance medication effects.

Will I have to stop taking my current medications?

You can continue taking your GLP-1 medication during the study. The trial does not specify if you need to stop any other medications.

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

Research has shown that high-protein diets are generally safe for most people. Studies have found that these diets typically don't cause health problems in healthy individuals. For instance, one study found that people on high-protein diets lost weight and improved their health without major side effects.

However, consuming a lot of protein can sometimes affect how the body manages blood sugar. This risk increases with very high protein intake, but it usually concerns diets with much more protein than typically recommended.

Overall, high-protein diets are well-tolerated and can aid in weight management. For those with health concerns, consulting a healthcare provider before making significant dietary changes is advisable.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for obesity, which often involve medications like GLP-1 receptor agonists, the investigational approach using protein-rich foods is unique because it combines dietary intervention with existing medication. The addition of protein-rich pork foods aims to provide high-quality protein intake, which can help enhance satiety, potentially leading to better weight management when combined with GLP-1 medications. Researchers are excited about this approach because it could offer a more holistic and sustainable method for managing obesity by integrating dietary habits with traditional pharmacological treatments.

What evidence suggests that protein-rich foods might be an effective treatment for obesity?

Studies have shown that high-protein diets can aid in weight loss and reduce body fat. In one study, participants lost about 3.7 kg (around 8 pounds) of body weight and 3.3 kg (about 7 pounds) of fat over six months. Another study found that high-protein diets might improve signs of metabolic syndrome, a group of conditions that increase the risk of heart disease and diabetes. Some evidence also suggests that consuming more protein can enhance weight control and might lead to losing an extra 5% of body weight compared to regular diets. In this trial, participants in the GLP-1 + Protein group will receive a dietary intervention with protein-rich foods, while those in the GLP-1 Only group will not. Although short-term results appear promising, experts hold differing views on the long-term benefits.16789

Are You a Good Fit for This Trial?

This trial is for women aged 30-60 who are overweight or obese (BMI over 25) and have started taking a GLP-1 medication within the last month. Participants must be generally healthy, willing to keep their current activity level, and able to follow study instructions.

Inclusion Criteria

I have taken GLP-1 medication prescribed by my doctor in the past 4 weeks.
* Willing and able to maintain current inactivity patterns throughout the study
* Willing and able to follow all study procedures
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will undergo a 12-week dietary protein intervention while continuing GLP-1 medication

12 weeks
Baseline and post-study assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Protein Rich Foods

Trial Overview

The study tests if eating more protein-rich foods while using GLP-1 medications helps with body composition, eating habits, health, and well-being in middle-aged women with excess weight. The intervention lasts for 12 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: GLP-1 + ProteinExperimental Treatment1 Intervention
Group II: GLP-1 Only (no dietary intervention)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials
387
Recruited
86,100+

National Pork Board

Collaborator

Trials
6
Recruited
390+

Citations

Clinical Evidence and Mechanisms of High-Protein Diet ... - PMC

After 6 months, participants in the high-protein group significantly lost BW (–3.7 kg; 95% CI, –6.2 to –1.3 kg) and fat mass (–3.3 kg; 95% CI, –5.5 to –1.1 kg) ...

Effect of a High-Protein Diet versus Standard ... - PMC - NIH

Some studies have shown that protein-enriched diets can lead to greater weight loss and improvements in biomarkers of metabolic syndrome (MeS) than standard ...

Protein Source Determines the Effectiveness of High ...

Conclusions: The source of dietary protein in HPDs significantly influences metabolic outcomes in obese rats, impacting adipocyte and pancreatic islet size, ...

Long-term effects of a high-protein weight-loss diet

A reported higher protein intake appears to confer some weight-loss benefit. Cardiovascular disease risk factors, biomarkers of disease, and serum vitamins and ...

High dietary protein intake is associated with an increased ...

High dietary protein diets are widely used to manage overweight and obesity. However, there is a lack of consensus about their long-term efficacy and safety.

Dietary Protein and Energy Balance in Relation to Obesity and ...

An additional increase of protein intake does not induce a larger loss of body weight, but can be effective to maintain a larger amount of fat-free mass.

Long-term risk of overweight/obesity according to the ...

An adequate quality of protein intake is important for body weight management and for preventing overweight/obesity. However, beyond the source of protein, ...

High-protein diets: Are they safe?

Diets high in protein aren't known to cause medical problems in healthy people. But there are a wide range of these types of diets.

Safety and efficacy of high-protein diets for weight loss

HP diets provide a potential benefit of improved compliance during WL attempts. HP diets increase WL at 12 months by about 3 kg compared with a ...