Time and Nutrient-Dependent Effects of Aerobic Exercise on Metabolism in Adults (TANDEM Study)
NCT ID: NCT06311487
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-04-15
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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TANDEM Exercise
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
Fasted-AM
Participants will engage in aerobic exercise within 4 hours of waking up, following a \>10h overnight fast across the 4d run-in and exercise metabolism assessment day. Energy and macronutrient-controlled meals will be consumed at \~08:00, \~13:00, and \~19:00. Plasma metabolite samples will be drawn immediately pre- and post- exercise.
Fed-AM
Participants will engage in exercise within 4 hours of waking up, approximately 1h after consuming breakfast across the 4d run-in and exercise metabolism assessment day. Energy and macronutrient-controlled meals will be consumed at \~07:00, \~12:00, and \~18:00. Plasma metabolite samples will be drawn immediately pre- and post-exercise.
Fasted-PM
Participants will engage in exercise between 8-12 hours after waking up, following a \~10h fast across the 4d run-in and exercise metabolism assessment day. Energy and macronutrient-controlled meals will be consumed at \~07:00 and \~18:00. Plasma metabolite samples will be drawn immediately pre- and post-exercise.
Fed-PM
Participants will engage in exercise between 8-12 hours after waking up, approximately 1h after consuming dinner across the 4d run-in and exercise metabolism assessment day. Energy and macronutrient-controlled meals will be consumed at \~07:00, \~12:00, and \~18:00. Plasma metabolite samples will be drawn immediately pre- and post-exercise.
Interventions
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Fasted-AM
Participants will engage in aerobic exercise within 4 hours of waking up, following a \>10h overnight fast across the 4d run-in and exercise metabolism assessment day. Energy and macronutrient-controlled meals will be consumed at \~08:00, \~13:00, and \~19:00. Plasma metabolite samples will be drawn immediately pre- and post- exercise.
Fed-AM
Participants will engage in exercise within 4 hours of waking up, approximately 1h after consuming breakfast across the 4d run-in and exercise metabolism assessment day. Energy and macronutrient-controlled meals will be consumed at \~07:00, \~12:00, and \~18:00. Plasma metabolite samples will be drawn immediately pre- and post-exercise.
Fasted-PM
Participants will engage in exercise between 8-12 hours after waking up, following a \~10h fast across the 4d run-in and exercise metabolism assessment day. Energy and macronutrient-controlled meals will be consumed at \~07:00 and \~18:00. Plasma metabolite samples will be drawn immediately pre- and post-exercise.
Fed-PM
Participants will engage in exercise between 8-12 hours after waking up, approximately 1h after consuming dinner across the 4d run-in and exercise metabolism assessment day. Energy and macronutrient-controlled meals will be consumed at \~07:00, \~12:00, and \~18:00. Plasma metabolite samples will be drawn immediately pre- and post-exercise.
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index 18.5-\<40 kg/m2
* Recreationally active: defined as \>100 minutes per week of voluntary exercise at moderate intensity or greater and \>60 min per day of total habitual physical activity (i.e., work related, transportation related) at moderate intensity or greater, over the past 3 months.
* No self-report of acute or chronic disease (cardiovascular disease (CVD), diabetes, pulmonary, gastrointestinal disorders, and orthopedic problems in particular).
* No plans to relocate within the next 6 months.
* No plans for extended travel (\>2 weeks) within the next 6 months.
* Live or work within 30 minutes of the AHWC (exceptions may be made at the discretion of the Study PI on a case-by-case basis for highly motivated subjects).
Exclusion Criteria
* No contraindications to exercise or limitations on ability to be physically active.
* Ability to complete AM or PM exercise and complete 4 exercise sessions per week.
* Ability to adhere to eating and exercise protocols (meal timing, exercising in fasted and fed states)
* Willing and able to wear activity/sleep monitor for 7 consecutive days.
* Willing not to enroll in any other formal weight loss or physical activity programs over 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
* Diastolic blood pressure \>100 mmHG, systolic blood pressure \>160 mmHG, or resting heart rate \>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position.
* Diabetes (fasting glucose \>/=126 mg/dL or Hemoglobin A1C \>/=6.5%) as measured during the screening visit.
* Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range as measured during the screening visit) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable.
* Hematocrit, white blood cell count or platelets significantly outside the normal reference range as measured on the screening visit.
* Triglycerides \>400 mg/dL as measured on the screening visit.
* LDL cholesterol \>200 mg/dL as measured on the screening visit.
* Abnormal resting electrocardiogram (ECG) as measured on the screening visit: serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval \> 480 msec or other significant conduction defects.
* Presence or history of any metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to participate in exercise: CVD, peripheral vascular disease, cerebrovascular disease, significant cardiac arrhythmias or cardiac valve disease, diabetes, uncontrolled hyper- or hypothyroidism, uncontrolled hypertension, cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis), HIV infection, significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease.
* Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, Ulcerative Colitis, chronic diarrhea, or active gallbladder disease.
* Significant pulmonary disorders including: chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma.
* Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
* Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism (e.g., appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
* Use of medications that would impact ability to achieve age-predicted maximum heart rate (e.g. beta blockers).
* Regular use of systemic steroids (other than Oral Contraceptive Pills).
* Regular use of obesity pharmacotherapeutic agents within the last 6 months.
* Current alcohol or substance abuse.
* Nicotine use (past 6 months).
* Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score \> 16 on the Center for Epidemiologic Studies Depression Scale (CES-D) will require further assessment by the Study MD to determine if it is appropriate for the subject to participate
* History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to the exercise conditions.
* Weight loss \>5% in past 3 months.
* Currently participating in or planning to participate in any formal weight loss or physical activity programs or clinical trials.
* Primary sleep disorders including but not limited to insomnia, obstructive sleep apnea, periodic limb movements in sleep, restless leg syndrome.
* Night-time shiftwork, rotating work, or other circadian disruptions and disorders (e.g., diagnosed delayed sleep-wake phase disorder).
* Self-reported long (\>9.25h) or short sleep (\<7h) that would make adhering the exercise conditions difficult.
* Regular use of prescription or over-the-counter medications known to affect sleep (e.g., benzodiazepines, doxepin, zolpidem, trazodone, diphenhydramine HCl, etc.).
* Regular use of melatonin (\>/=2 days per week).
* High consumption of caffeine (\>500 mg/d) or unwilling to abstain from caffeine consumption during run-in and in-patient protocol.
* Planned travel \>1 time zone away 4 weeks prior to study start or at any time during study protocol.
18 Years
40 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Seth Creasy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Other Identifiers
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23-1388
Identifier Type: -
Identifier Source: org_study_id