- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07487090
Fasted vs. Fed State Exercise
Fasted vs. Fed State Exercise for Cardiovascular Health and Weight Loss
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Kyle D Flack, PhD
- Phone Number: (479) 434-4019
- Email: kyle.flack@achehealth.edu
Study Contact Backup
- Name: Blake Metcalf, DCN
- Phone Number: 479-434-4003
- Email: blake.metcalf@achehealth.edu
Study Locations
-
-
Arkansas
-
Fort Smith, Arkansas, United States, 72916
- Recruiting
- Arkansas Colleges of Health Education Research Institure Health and Wellness Center
-
Contact:
- Kyle D Flack, PhD
- Phone Number: (479) 434-4019
- Email: kyle.flack@achehealth.edu
-
Contact:
- Blake Metcalf, DCN
- Phone Number: 4794344003
- Email: blake.metcalf@achehealth.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fasted group
Complete all exercise sessions of intervention before breakfast- fasted at least 8 hours
|
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).
|
|
Experimental: Fed exercise group
Complete all exercise sessions of intervention after breakfast- within 3 hours of eating at least 300 kcal
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
body composition
Time Frame: Baseline (week 0) and post-intervention (week 25)
|
kg of fat free and fat mass via DXA
|
Baseline (week 0) and post-intervention (week 25)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (week 0) and post-intervention (week 25)
|
|
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.
|
Baseline (week 0) and post-intervention (week 25)
|
|
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.
|
Baseline (week 0) and post-intervention (week 25)
|
|
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.
|
Baseline (week 0) and post-intervention (week 25)
|
|
Food reinforcement
Time Frame: Baseline (week 0) and post-intervention (week 25)
|
amount of work one is willing to do for a snack food
|
Baseline (week 0) and post-intervention (week 25)
|
|
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
|
Baseline (week 0) and post-intervention (week 25)
|
|
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
|
Baseline (week 0) and post-intervention (week 25)
|
|
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.
|
Baseline (week 0) and post-intervention (week 25)
|
|
resting metabolic rate
Time Frame: Baseline (week 0) and post-intervention (week 25)
|
Resting metabolic rate assessed via indirect calorimetry
|
Baseline (week 0) and post-intervention (week 25)
|
|
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
|
Baseline (week 0) and post-intervention (week 25)
|
|
muscle power
Time Frame: Baseline (week 0) and post-intervention (week 25)
|
Average power (watts) will be assessed during an isokinetic and isometric task
|
Baseline (week 0) and post-intervention (week 25)
|
|
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
|
Baseline (week 0) and post-intervention (week 25)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 479-401-6011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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