Weight Loss + Exercise for Aging-related Inflammation

(ALIVE Trial)

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

Trial Summary

What is the purpose of this trial?

Over half of adults in this country are overweight. This increases risk for heart and blood pressure problems, cancer, stroke and arthritis. While it is difficult to lose large amounts of weight and keep it off, even small amounts of weight loss can improve health. Furthermore, fat is increasingly recognized as a source of substances that increase inflammation. It may be that some of the adverse consequences of being overweight are due to increased inflammation. We are asking you to volunteer for a research study in which you may lose a moderate amount of weight and increase your activity. It is important that you read and understand the information on this form. The purposes of these studies are to determine the influence(s) of age and body composition on the production of inflammatory chemicals by fat (adipose tissue), the mechanisms controlling this, and if a weight loss and aerobic exercise intervention results in a decrease in 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 data supports the effectiveness of the treatment Weight loss and aerobic exercise training for reducing aging-related inflammation?

Research shows that losing weight and exercising can lower inflammation, which is linked to many chronic diseases. Studies suggest that combining weight loss with exercise is more effective at reducing inflammation than weight loss alone. ^{1 2 3 4 5}

Is weight loss combined with exercise safe for reducing inflammation in humans?

Research shows that combining weight loss with exercise, including aerobic and resistance training, is generally safe and can reduce inflammation in various groups, such as obese men and postmenopausal women. These interventions have been associated with improvements in body composition and inflammatory markers without significant safety concerns. ^{6 7 8 9 10}

How does the treatment of weight loss and aerobic exercise training differ from other treatments for aging-related inflammation?

This treatment is unique because it combines dietary weight loss with aerobic exercise, which together are more effective at reducing inflammation than weight loss alone. Unlike some treatments that focus solely on medication, this approach uses lifestyle changes to target inflammation, potentially offering a more holistic and sustainable solution. ^{1 4 5 11 12}

Research Team

Jacob B Blumenthal, MD

Principal Investigator

Baltimore VA Medical Center, University of Maryland

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Behavioural treatments for chronic systemic inflammation: effects of dietary weight loss and exercise training. [2022]

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

Obesity and physical frailty in older adults: a scoping review of lifestyle intervention trials. [2022]

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

Independent and combined effects of physical activity and weight loss on inflammatory biomarkers in overweight and obese older adults. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Resistance exercise training-induced decrease in circulating inflammatory CD14+CD16+ monocyte percentage without weight loss in older adults. [2021]

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

Influence of Weight Reduction and Enhanced Protein Intake on Biomarkers of Inflammation in Older Adults with Obesity. [2020]

6. England pubmed.ncbi.nlm.nih.gov

The effect of exercise interventions on inflammatory biomarkers in healthy, physically inactive subjects: a systematic review. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

The effects of combined aerobic and resistance training on inflammatory markers in obese men. [2020]

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

Dietary Weight Loss, Exercise, and Inflammation in Older Adults with Overweight or Obesity and Cardiometabolic Disease. [2020]

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

A yearlong exercise intervention decreases CRP among obese postmenopausal women. [2021]

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

Effect of diet with and without exercise training on markers of inflammation and fat distribution in overweight women. [2022]

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

Effects of a caloric restriction weight loss diet and exercise on inflammatory biomarkers in overweight/obese postmenopausal women: a randomized controlled trial. [2021]

12. Denmark pubmed.ncbi.nlm.nih.gov

Combined aerobic and resistance training decreases inflammation markers in healthy men. [2022]