Weight Loss + Exercise for Aging-related Inflammation

(ALIVE Trial)

Recruiting in Baltimore (>99 mi)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, College Park

Must not be taking: Lipitor, Crestor, Beta blockers, others

Disqualifiers: Diabetes, Hypertension, Hyperlipidemia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how weight loss and aerobic exercise training can reduce inflammation caused by excess body fat. Researchers seek to understand how age and body composition affect the production of inflammatory chemicals in the body. Participants will follow a specific diet and exercise plan to determine if these changes can lower inflammation levels. This trial may suit individuals who are overweight and have a stable medical regimen, particularly those who have struggled with maintaining weight loss. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research on lifestyle changes and inflammation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require a stable medical regimen for at least 30 days. Some medications affecting glucose, lipid, or cytokine levels are excluded, so you may need to discuss your specific medications with the study team.

What prior data suggests that this weight loss and aerobic exercise training is safe?

Research has shown that losing weight and engaging in aerobic exercise are generally safe for most people. These activities can help reduce inflammation in the body. For instance, one study found that aerobic exercise significantly lowered levels of C-reactive protein (CRP), a substance in the blood that signals inflammation. Another study found that regular aerobic exercise improved inflammation levels in older adults.

While exercise and dietary changes can be beneficial, they should be approached carefully. Serious problems from exercising or dieting are rare when done correctly. However, consulting a healthcare professional before starting any new exercise or diet plan is always wise, especially if existing health issues are present. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of weight loss and aerobic exercise for reducing aging-related inflammation because it tackles the issue through lifestyle modification, rather than medication. Unlike standard treatments that often rely on anti-inflammatory drugs, this approach focuses on a hypocaloric diet paired with regular aerobic exercise, which can naturally lower inflammation levels. This method not only targets the inflammation but also promotes overall health benefits, making it a holistic approach to managing inflammation related to aging.

What evidence suggests that weight loss and aerobic exercise training might be an effective treatment for aging-related inflammation?

Research has shown that regular aerobic exercise and weight loss can reduce inflammation in older adults. In this trial, participants will follow a lifestyle modification program combining a hypocaloric diet with aerobic exercise training. Studies have found that regular aerobic exercise can lower levels of certain chemicals, such as CRP and TNF-α, which are linked to inflammation. Exercising for at least 150 minutes a week can also reduce waist size and body fat. Additionally, consuming fewer calories can decrease age-related inflammation. These changes may mitigate the negative effects of being overweight, especially as people age. ^{2 4 6 7 8}

Who Is on the Research Team?

Jacob B Blumenthal, MD

Principal Investigator

Baltimore VA Medical Center, University of Maryland

Are You a Good Fit for This Trial?

This study is for veterans who are overweight with a waist size of 80-120cm for men or 70-110cm for women, have a stable medical regimen, and BMI between 20-40. Women over 50 must be postmenopausal. Participants should not smoke, have certain chronic diseases, uncontrolled hypertension, recent significant weight changes, or use medications affecting metabolism.

Inclusion Criteria

I am a woman over 50, postmenopausal for 1+ year, and not on hormone therapy.

Waist 80-120cm (men), 70-110cm (women)

BMI 20-40 kg/m2

Exclusion Criteria

I need more than 3 medications or beta blockers to manage my high blood pressure.

My weight has changed by more than 5kg in the last 3 months.

I have a long-term liver, kidney, or blood disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a weight loss and aerobic exercise intervention to study its effects on inflammation and metabolic profiles

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for changes in inflammatory markers and metabolic profiles after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Weight loss and aerobic exercise training

Trial Overview The trial aims to see if losing some weight and doing more aerobic exercise can reduce inflammation in the body. It's looking at how age and body fat affect the production of inflammatory chemicals and whether these lifestyle changes can improve health outcomes related to being overweight.

How Is the Trial Designed?

Group I: Lifestyle Modification Experimental Treatment 1 Intervention

Combined hypocaloric diet and aerobic exercise training

Who Is Running the Clinical Trial?

University of Maryland, College Park

Lead Sponsor

Trials

163

Recruited

46,800+

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12335091/

Impact of aerobic exercise on chronic inflammation in older ... This review demonstrates that aerobic exercise training significantly improves inflammatory markers in older adults, reducing CRP, TNF-α, and IL ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828487

Aerobic Exercise and Weight Loss in Adults: A Systematic ... Aerobic exercise at least 150 minutes per week was associated with clinically important reductions in waist circumference and measures of body fat.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0531556525000762

Balancing benefits and risks of aerobic exercise for aging ... After 16 weeks of exercise, the aged mice showed a produces consumptive weight loss, an increase inflammation level in adipose tissue, and a ...

4. nature.com nature.com/articles/s41598-025-11076-w

Effects of resistance training and aerobic ... This study investigated the effectiveness of a resistance and aerobic training model among 71 middle-aged participants aged 30–60 (mean age ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3320801/

Exercise, Inflammation and Aging - PMC - PubMed Central - NIH In short, reductions in caloric intake resulting in weight loss may provide one mechanism to dampen age-related inflammation [21]. Other research has focused on ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6941888/

Dietary Weight Loss, Exercise, and Inflammation in Older ... Weight loss is known to reduce biomarkers of inflammation. Evidence suggests that aerobic exercise and resistance exercise reduce inflammation, but for aerobic ...

7. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2019.00098/full

Effect of Aerobic Exercise on Inflammatory Markers ... The pooled results showed that aerobic exercise significantly reduced inflammatory markers (C-reactive protein (CRP): SMD = 0.53, 95% CI 0.26– ...

8. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-025-01279-z

Impact of aerobic exercise on chronic inflammation in older ... The results indicate that regular aerobic exercise training significantly improves many inflammatory factors in older adults, including CRP, TNF ...