Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07487090

Fasted vs. Fed State Exercise

Although many medications exist for both heart disease and obesity, cost, lack of access for all people, side effects and the desire for a more natural solution have left many people seeking lifestyle treatments such as exercise. Scientists know that exercise is highly beneficial for heart health. When exercise also produces weight loss, these benefits are much improved. Although using exercise to treat or prevent heart disease / obesity is recommended, not all people respond well. Some see significant weight loss and health improvements while others see little changes. For these reasons, new strategies surrounding the use and design of an exercise program are needed. One such strategy could be performing aerobic exercise before breakfast (fasted exercise). When exercising fasted, food/energy stores are low, and one relies on stored body fat for energy. This may help heart health and weight loss. This has never been tested in a program long enough to see such changes. This study will, for the first time, assess the effects of a 16-week aerobic exercise program performed fasted compared to after eating. Outcomes will include blood fats, blood pressure, fat-burning abilities and weight loss.

Starting an exercise program can also make people to eat more. This limits the success of exercise. The study will also evaluate ways fasted exercise could change eating, as it possible that fasted exercise could also cause people to eat more, which would limit weight loss and health improvements.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

This study will be the first to evaluate a long-term (16-week) aerobic exercise intervention performed in the fasted state (compared to fed state) at a guidelines-based dose. Primary outcomes for Aim 1 will include changes in fat & fat-free mass (DXA), energy compensation, blood pressure & lipids, aerobic fitness, and substrate oxidation (respiratory quotient, RQ) at rest and during activity.

It is also important to understand sources of response variability to an exercise program. Individuals tend to compensate for the energy they expend during exercise, primarily by increasing energy intake (EI). Such compensatory eating behaviors likely stem from a series of evolutionarily conserved responses, ensuring energy is available for vital organ function and reproduction when faced with an energy deficit. This proposal will be the first to evaluate how fasted exercise training influences (Aim 2 outcomes): physiological hunger (hormonal responses to a standardized meal) and behavioral constructs shown to influence EI and weight status (food reinforcement and attentional bias towards food cues). The overall hypothesis is that fasted state exercise will result in greater energy compensation, attenuating weight loss compared to an identical dose of exercise performed in the post-prandial state. This study will further hypothesize an attenuated weight loss with fasted exercise training will negate beneficial cardiovascular adaptations stemming from improvements in oxidative metabolism commonly associated with fasted exercise. Adults (aged 18-59 years, BMI: 25-45 kg/m2) will be randomized to a 16-week supervised aerobic exercise intervention (progressing to a guidelines-based dose of 1600 kcal/wk). Exercise sessions will be performed between 0500h and 1100h, 4 days per week in either the fasted state (FAST, 8-12 hour fast) or post-prandially (FED, within 3 hours of eating at least 300 kcal).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-59
  • BMI 25-45
  • Healthy enough to exercise

Exclusion criteria

  • Taking medications or supplements that are known to influence energy expenditure,
  • Currently exercising more than once per week
  • Currently dieting for weight loss
  • Currently taking weight loss drugs
  • Have had a previous weight loss surgery
  • Currently diagnosed with Diabetes
  • Currently diagnosed with heart disease (Heart failure, uncontrolled hypertension, uncontrolled hypercholesterolemia, Coronary heart disease)

Treatment and study plan

16 week exercise intervention

Behavioral

Both groups will receive a 16-week supervised aerobic exercise program progressing to 1,600 kcal of EE per wk (4 sessions/week) at moderate intensity (40-50% heart rate reserve, HRR).

Primary outcomes

  1. body composition

    Time frame: Baseline (week 0) and post-intervention (week 25)

    kg of fat free and fat mass via DXA

Secondary outcomes

  1. Total and acylated ghrelin

    Time frame: Baseline (week 0) and post-intervention (week 25)

    Total and acylated ghrelin (pg/mL in plasma) will be assessed in the fasted state and response to a test meal via blood sampling at 0 minutes (pre meal), 15, 30, 45, 60, 90, and 120 minutes post-meal.

  2. GLP-1

    Time frame: Baseline (week 0) and post-intervention (week 25)

    Glucagon-like peptide 1 (GLP-1, Pmol/L in plasma) will be assessed in the fasted state and response to a test meal via blood sampling at 0 minutes (pre meal), 15, 30, 45, 60, 90, and 120 minutes post-meal.

  3. PYY

    Time frame: Baseline (week 0) and post-intervention (week 25)

    Peptide YY (PYY, pmol/L plasma) will be assessed in the fasted state and response to a test meal via blood sampling at 0 minutes (pre meal), 15, 30, 45, 60, 90, and 120 minutes post-meal.

  4. Leptin

    Time frame: Baseline (week 0) and post-intervention (week 25)

    Leptin (ng/mL in plasma) will be assessed in the fasted state and response to a test meal via blood sampling at 0 minutes (pre meal), 15, 30, 45, 60, 90, and 120 minutes post-meal.

  5. Food reinforcement

    Time frame: Baseline (week 0) and post-intervention (week 25)

    amount of work one is willing to do for a snack food

  6. Attentional bias for food cues

    Time frame: Baseline (week 0) and post-intervention (week 25)

    percentage of time fixated on food cues during a dot-probe task, assessed by eye tracking

  7. Skeletal muscle efficiency

    Time frame: Baseline (week 0) and post-intervention (week 25)

    kcal expended per kg per watt during a graded cycle ergometer test

  8. walking ecconomy

    Time frame: Baseline (week 0) and post-intervention (week 25)

    Gross energetic cost of movement (J/kg/m) will be assessed during a graded walking test with indirect calorimetry.

  9. resting metabolic rate

    Time frame: Baseline (week 0) and post-intervention (week 25)

    Resting metabolic rate assessed via indirect calorimetry

  10. muscle strength

    Time frame: Baseline (week 0) and post-intervention (week 25)

    Peak torque and work per repetition (Foot-Pounds) will be assessed during an isokinetic and isometric task

  11. muscle power

    Time frame: Baseline (week 0) and post-intervention (week 25)

    Average power (watts) will be assessed during an isokinetic and isometric task

  12. skeletal muscle mass

    Time frame: Baseline (week 0) and post-intervention (week 25)

    The D3Cr dilution technique will be used to determine kg of skeletal muscle mass

Study contacts

Contact information is provided by the study sponsor or research team.

Blake Metcalf, DCN

CONTACT

[email protected]

479-434-4003

Kyle D Flack, PhD

CONTACT

[email protected]

(479) 434-4019

Sponsors and collaborators

Lead sponsor

Arkansas Colleges of Health Education

Other

Registry information

Official study title

Fasted vs. Fed State Exercise for Cardiovascular Health and Weight Loss

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.