Time and Nutrient-Dependent Effects of Aerobic Exercise on Metabolism in Adults (TANDEM Study)

NCT06311487 | Active Not Recruiting

• 2 other identifiers: 23-13881R56DK136601-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to learn more about metabolic responses to aerobic exercise at different times of the day (morning or evening) under fasting versus fed conditions.

Conditions

Overweight and Obesity; Healthy

Outcome Measures

Primary Outcomes (2)

• Exercise Energy Expenditure (kcals)

  On Day 5 of each condition, participants will complete a 45-minute exercise test on the treadmill to compare exercise energy expenditure and fat oxidation between. O2 and CO2 content of expired air will be measured continuously by open circuit spirometry and averaged every minute using an automated online system (TrueMax 2400; Parvo-Medics, Sandy, UT). Exercise energy expenditure will be determined from minute-by-minute values, measured in kcals.

  Fasted-AM Day 5, Fed-AM Day 5, Fasted-PM Day 5, Fed-PM Day 5

• Substrate Oxidation (Respiratory Quotient)

  On Day 5 of each condition, participants will complete a 45-minute exercise test on the treadmill to compare exercise energy expenditure and fat oxidation between. O2 and CO2 content of expired air will be measured continuously by open circuit spirometry and averaged every minute using an automated online system (TrueMax 2400; Parvo-Medics, Sandy, UT). Substrate Oxidation will be determined from minute-by-minute values, measured in respiratory quotient.

  Fasted-AM Day 5, Fed-AM Day 5, Fasted-PM Day 5, Fed-PM Day 5

Study Arms (1)

TANDEM Exercise

EXPERIMENTAL

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

Behavioral: Fasted-AM; Behavioral: Fed-AM; Behavioral: Fasted-PM; Behavioral: Fed-PM

Interventions

Fasted-AM BEHAVIORAL

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.

TANDEM Exercise

Fed-AM BEHAVIORAL

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.

TANDEM Exercise

Fasted-PM BEHAVIORAL

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.

TANDEM Exercise

Fed-PM BEHAVIORAL

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.

TANDEM Exercise

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 years
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seth Creasy, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 15, 2024
• Study Start: April 15, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)