Aerobic Exercise Timing for Obesity

(TANDEM Trial)

Overseen By Shelby Panter, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Appetite suppressants, Antipsychotics, Beta blockers, others

Disqualifiers: Diabetes, Hypertension, Depression, others

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

Compensation: Varies

Number of Visits: 4

Duration: 5 days per condition

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the timing of aerobic exercise, such as running or cycling, affects metabolism when performed in the morning or evening, either before or after eating. The goal is to understand how different exercise schedules impact weight and health for individuals struggling with obesity. Participants will complete exercise sessions both on an empty stomach and after meals. Ideal participants are those who have been consistently active for over three months, exercising at least 100 minutes a week, and do not have any acute or chronic diseases. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on exercise timing and metabolism.

Will I have to stop taking my current medications?

The trial requires that you do not regularly use medications that significantly impact appetite, weight, energy metabolism, heart rate, or sleep. If you are on such medications, you may need to stop taking them to participate.

What prior data suggests that aerobic exercise is safe for obesity?

Research shows that aerobic exercise is generally safe for most people. Studies have found that regular aerobic activities can aid in weight loss, reduce waist size, and lower body fat. For instance, engaging in at least 150 minutes of aerobic exercise each week links to noticeable health benefits.

Aerobic exercise benefits heart and overall health. Active individuals face a lower risk of health problems compared to those who don't exercise regularly. No major safety concerns have been reported with aerobic exercise, making it a well-tolerated activity.

Overall, research supports the safety of aerobic exercise. It can be a beneficial part of a healthy lifestyle for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the timing of aerobic exercise and whether it's done in a fed or fasted state could influence obesity outcomes. Unlike standard obesity treatments that often focus on diet adjustments or medications, this approach examines the body's response to exercise at different times of the day and nutritional states. By understanding if and how these factors impact weight loss, this trial could unlock new, non-invasive strategies for managing obesity that are tailored to an individual's lifestyle and biological rhythms.

What evidence suggests that aerobic exercise timing is effective for obesity?

Research has shown that aerobic exercise can significantly aid in weight loss and body fat reduction. One study found that engaging in at least 150 minutes of aerobic exercise weekly led to noticeable reductions in waist size and body fat. Another study demonstrated that overweight and obese participants who regularly performed aerobic exercise lost an average of 4.1% of their body weight. Additionally, aerobic exercise can improve several heart disease risk factors, such as insulin resistance and high blood pressure. This trial will explore the effects of aerobic exercise timing, with participants engaging in morning or evening sessions, either in a fasted or fed state. These findings suggest that aerobic exercise, whether in the morning or evening, can effectively support weight loss and improve overall health in people with obesity. ^{2 6 7 8 9}

Who Is on the Research Team?

Seth Creasy, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults who are generally healthy but living with obesity. Participants should be interested in how aerobic exercise affects metabolism under different conditions, such as fasting or after eating.

Inclusion Criteria

No plans to relocate within the next 6 months

For Females: Not currently pregnant or lactating, not pregnant within the past 6 months, not planning to become pregnant in the next 6 months

Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures

Exclusion Criteria

Diabetes (fasting glucose >/=126 mg/dL or Hemoglobin A1C >/=6.5%) as measured during the screening visit

Nicotine use (past 6 months)

LDL cholesterol >200 mg/dL as measured on the screening visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in aerobic exercise under different conditions (fasted/fed, AM/PM) to study metabolic responses

5 days per condition

4 visits (in-person) for each condition

Follow-up

Participants are monitored for metabolic changes and energy expenditure after exercise sessions

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise

Trial Overview The TANDEM Study is testing the effects of aerobic exercise on metabolism when done at various times (morning vs evening) and states (fasting vs fed). It aims to understand how timing and nutrient intake influence metabolic responses.

How Is the Trial Designed?

Group I: TANDEM Exercise Experimental Treatment 4 Interventions

Participants in this arm will engage in morning aerobic exercise while in a fasted state, morning aerobic exercise while in a fed state, evening aerobic exercise while in a fasted state, and evening aerobic exercise while in a fed state in a randomly assigned order

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A systematic review of 88 studies involving 3964 adults with overweight or obesity found that all types of exercise training significantly improved maximal oxygen consumption (VO2max), with an average increase of 3.82 ml/min/kg.

Aerobic training was more effective than resistance training for improving VO2max, while high-intensity interval training (HIIT) showed slightly better results than aerobic training; however, resistance training is essential for enhancing muscle strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of different types of regular exercise on physical fitness in adults with overweight or obesity: Systematic review and meta-analyses. van Baak, MA., Pramono, A., Battista, F., et al.[2021]

This study will investigate the effects of linear periodized versus non-periodized combined training on health markers in obese adults aged 20-50, using a randomized controlled trial design over 16 weeks with 60-minute sessions, three times a week.

The research aims to assess various health-related outcomes, including body composition and cardiovascular fitness, to determine the optimal training approach for improving health in individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of linear periodized and non-periodized combined training in health markers and physical fitness of adults with obesity: Clinical trial protocol. Streb, AR., da Silva, RP., Leonel, LDS., et al.[2020]

Obese males with mild hypertension showed significantly lower exercise capacity, measured by VO2 and work rate, compared to control subjects, indicating a need for tailored exercise prescriptions.

A one-year follow-up study demonstrated that low-intensity aerobic exercise improved both body composition and resting blood pressure in obese individuals, regardless of hypertension status, suggesting that even moderate exercise can have beneficial health effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of exercise prescription for hypertensive obese men by ventilatory threshold. Miyatake, N., Nishikawa, H., Morishita, A., et al.[2019]

In a randomized controlled trial involving 31 morbidly obese participants, both aerobic training (AT) and resistance training (RT) significantly improved health-related fitness measures compared to a control group, including enhancements in walking distance, skin-fold thickness, and psychological factors like self-efficacy.

RT showed additional benefits over the control group in reducing BMI and waist circumference, indicating that while both exercise types are effective, resistance training may offer extra advantages in certain anthropometric measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of 12 weeks supervised exercise in obesity management. Herring, LY., Wagstaff, C., Scott, A.[2015]

In a study of 21 obese middle-aged and older men, 9 months of aerobic exercise (AEX) followed by weight loss (WL) significantly improved cardiac risk factors, including a reduction in glucose and insulin responses during glucose tolerance tests, compared to AEX alone.

The combination of AEX and WL also led to favorable changes in lipid profiles, including a 17% decrease in triglycerides and an 8% reduction in LDL cholesterol, highlighting the importance of both exercise and weight loss for better heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential effects of aerobic exercise training and weight loss on risk factors for coronary disease in healthy, obese middle-aged and older men. Katzel, LI., Bleecker, ER., Rogus, EM., et al.[2019]

To effectively prevent weight gain and regain after weight loss, adults should engage in more than 150 minutes, ideally 300 minutes, of moderate-intensity aerobic activity each week.

For significant weight and fat loss, a minimum of 300 to 420 minutes of moderate-intensity aerobic exercise per week is necessary, while the amount needed to reduce central fat may be less than that required for overall weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in the management of obesity in adults: A position statement from Exercise and Sport Science Australia. Johnson, NA., Sultana, RN., Brown, WJ., et al.[2021]

A systematic review of 20 randomized controlled trials involving 2,062 women with obesity found that any form of exercise significantly improved cardiorespiratory fitness and body composition compared to no exercise, although the improvements were modest.

Aerobic exercise, particularly at moderate to vigorous intensity, was the most effective for enhancing fitness and reducing body weight, while low-load resistance training showed the greatest reduction in body fat.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of training modes on fitness and body composition in women with obesity: A systematic review and meta-analysis. Davis, ME., Blake, C., Perrotta, C., et al.[2022]

In a study of 27 inactive men with obesity over 12 weeks, resistance exercise (RE) significantly reduced fat mass by 4.39% and increased lean mass by 2.12%, while also improving muscle strength and cardiorespiratory capacity without changing overall body weight.

Aerobic exercise (AE) also decreased fat mass by 5.91% and improved cardiorespiratory capacity by 19.07%, but did not affect lean mass or muscle strength, suggesting that RE may be more effective for building muscle and strength in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influences of Resistance versus Aerobic Exercise on Physiological and Physical Fitness Changes in Previously Inactive Men with Obesity: A Prospective, Single-Blinded Randomized Controlled Trial. Kim, B., Kim, S.[2022]

The study successfully randomized 33 adults with overweight and obesity to either morning or evening aerobic exercise, achieving a high retention rate of 94% and adherence of over 90% to the exercise program.

Both morning and evening exercise groups showed changes in total daily energy expenditure (TDEE), with the morning group increasing TDEE more significantly, suggesting that the timing of exercise may influence energy balance and weight management, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Morning and Evening Exercise on Energy Balance: A Pilot Study. Creasy, SA., Wayland, L., Panter, SL., et al.[2022]

Regular aerobic exercise for more than 24 weeks can lead to small improvements in vascular function, specifically flow-mediated dilation (FMD), in obese and overweight older adults, with a moderate effect seen when exercising more than three times a week.

The study, which analyzed data from 26 studies involving 1418 participants, found that while aerobic exercise reduced pulse wave velocity (PWV) slightly, it had no significant effect on the augmentation index (Aix), suggesting that consistent aerobic activity is beneficial for vascular health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of regular aerobic exercise on vascular function in overweight or obese older adults: A systematic review and meta-analysis. Li, P., Liu, Z., Wan, K., et al.[2023]

A study involving 112 adults with obesity identified key themes of 'readiness' for performing aerobic exercises, highlighting the importance of physical and mental states such as feeling rested and in a positive mood for both low-demand and high-demand bouts.

For high-demand bouts, additional factors like physical fitness, proper hydration, and enhanced motivation were crucial, suggesting that a readiness checklist could help optimize exercise prescriptions for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Readiness to Perform Aerobic Activity in Adults With Obesity: A Thematic Analysis of Online Surveys. Strohacker, K., Zakrajsek, RA., Schaltegger, ET., et al.[2020]

In a study involving 17.9-year-old male patients with obesity, a novel interval training method targeting respiratory muscles (RMIT) combined with a body weight reduction program led to significant improvements in exercise tolerance and reduced perceived effort during heavy-intensity cycling.

RMIT not only decreased the cardiorespiratory burden but also increased peak pulmonary oxygen uptake and time to exhaustion, demonstrating its efficacy in enhancing the integrative response to exercise in young patients with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory Muscle Interval Training Improves Exercise Capacity in Obese Adolescents during a 3-Week In-Hospital Multidisciplinary Body Weight Reduction Program. Salvadego, D., Tringali, G., De Micheli, R., et al.[2023]

Citations

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

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.121.008243

Comparative Efficacy of 5 Exercise Types on ... Interval training, although intense, appears to be an effective and time-efficient exercise mode for individuals with overweight and obesity to ...

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Physical activity People who are insufficiently active have a 20% to 30% increased risk of death compared to people who are sufficiently active. Regular physical ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39724371/

Aerobic Exercise and Weight Loss in Adults Engaging in 30 minutes of aerobic exercise per week was associated with modest reductions in body weight, waist circumference, and body fat measures among ...

9. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.125.325526

Epidemiology and Cardiovascular Benefits of Physical ... In this review, we focus on the beneficial effects of routine physical activity (PA) on the cardiovascular system, the different ways we can achieve and ...