Skip to main content
Clinical Trials/NCT05513300
NCT05513300
Active, not recruiting
Not Applicable

Physiological and Molecular Effects of High-intensity Interval Training (HIIT) vs. Moderate-intensity Continuous Training (MICT)

Stanford University1 site in 1 country135 target enrollmentJanuary 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lifestyle
Sponsor
Stanford University
Enrollment
135
Locations
1
Primary Endpoint
Clinical markers
Status
Active, not recruiting
Last Updated
5 months ago

Overview

Brief Summary

The purpose of this study is to compare the impact of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on human health outcomes in healthy sedentary subjects, over 12 weeks of exercise training.

The investigators will compare several health parameters, such as changes in multiomics profile, cardiorespiratory fitness, muscle strength, and body composition, before and after 12-week interventions of either HIIT or MICT.

Registry
clinicaltrials.gov
Start Date
January 10, 2023
End Date
August 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Francois Haddad

Clinical Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Be 18-65 years of age
  • Not be pregnant or lactating in the last 12 months, or planning to become pregnant for the next 4 months. A pregnancy test will be performed on the day of DXA scan in women of child-bearing potential. Not be post-partum during the last 12 months.
  • Be generally healthy (a list of medical conditions and/or medication that will exclude participants is listed in the section below)
  • Body mass index (BMI) \> 18 to \< 40 kg/m2
  • Sedentary in the past year, defined as regular (structured) endurance exercise (e.g., brisk walking, jogging, running, cycling, elliptical, or swimming activity that results in feelings of increased heart rate, rapid breathing, and/or sweating) or resistance training (resulting in muscular fatigue), no more than 1 hour per week.
  • Persons bicycling as a mode of transportation to and from work \>1 day/week etc. will not be considered sedentary.
  • Leisure walkers are included unless they meet the heart rate, breathing, and sweating criteria noted above.

Exclusion Criteria

  • Exclusion criteria are confirmed by either self-report (i.e., medical and medication histories reviewed by a clinician), screening tests performed by the study team, and/or clinician judgment as specified for each criterion.
  • A person may not participate in this study if any of the following applies to them:
  • Diabetes (self-report and screening tests), which includes: i) treatment with any hypoglycemic agents (self-report, even for non-diabetic reasons) or ii) fasting glucose \>125 or A1c \>6.4 (screening test).
  • Abnormal bleeding or coagulopathy (self-report): history of a bleeding disorder or clotting abnormality.
  • Thyroid disease (screening test):
  • Thyroid Stimulating Hormone (TSH) value outside of the normal range for the laboratory. Individuals with hypothyroidism may be referred to their primary care provider (PCP) for evaluation and retested; any medication change must be stable for more than 3 months prior to retesting.
  • Individuals with hyperthyroidism are excluded, including those with normal TSH on pharmacologic treatment.
  • Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) and/or pulmonary hypertension.
  • Metabolic bone disease (self-report): i) history of non-traumatic fracture from a standing height or less and/or ii) current pharmacologic treatment for low bone mass or osteoporosis, other than calcium, vitamin D, or estrogen.
  • Estrogens, progestins (self-report): supplemental, replacement or therapeutic use of estrogens or progestins within the last 6 months, other than birth control or to control menopausal symptoms.

Outcomes

Primary Outcomes

Clinical markers

Time Frame: Baseline; 12 weeks

Changes in measured lipids in mg/dL including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides

Cardiopulmonary Exercise Testing

Time Frame: Baseline; 12 weeks

Change in VO2 max after training, measured during cardiopulmonary exercise testing

Lipidome after 12-week intervention

Time Frame: Baseline; 12 weeks

Change in lipids measured in biospecimens after 12 weeks of training

Epigenome after 12-week intervention

Time Frame: Baseline; 12 weeks

Change in epigenome measured in biospecimens after 12 weeks of training

Transcriptome after 12-week intervention

Time Frame: Baseline; 12 weeks

Change in mRNA-based expression measured in biospecimens after 12 weeks of training

Metabolome after 12-week intervention

Time Frame: Baseline; 12 weeks

Change in metabolites measured in biospecimens after 12 weeks of training

Proteome after 12-week intervention

Time Frame: Baseline; 12 weeks

Change in protein measured in biospecimens after 12 weeks of training

Secondary Outcomes

  • Blood glucose(Baseline; 12 weeks)
  • Lipidome after acute exercise(Baseline; 12 weeks)
  • Lean muscle mass(Baseline; 12 weeks)
  • Fat mass(Baseline; 12 weeks)
  • Transcriptome after acute exercise(Baseline; 12 weeks)
  • Proteome after acute exercise(Baseline; 12 weeks)
  • Leg strength(Baseline; 12 weeks)
  • Exercise Motivation(Baseline; 12 weeks)
  • LV diastolic volume(Baseline; 12 weeks)
  • Left ventricle (LV) mass(Baseline; 12 weeks)
  • Metabolome after acute exercise(Baseline; 12 weeks)
  • Resting heart rate(Baseline; 12 weeks)
  • Metagenome profile(Baseline; 12 weeks)
  • Ejection fraction(Baseline; 12 weeks)
  • Depression(Baseline; Week 4, 8, 12)
  • Perceived Stress(Baseline; Week 4, 8, 12)
  • Hand grip strength(Baseline; 12 weeks)
  • Exercise Self-Efficacy(Baseline; 12 weeks)
  • Epigenome after acute exercise(Baseline; 12 weeks)
  • Generalized Anxiety(Baseline; Week 4, 8, 12)

Study Sites (1)

Loading locations...

Similar Trials