LifestyleNCT05513300
HIIT vs. MICT Training Study
A study testing Exercise intervention in people with Lifestyle and Sedentary, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 35Show fewer
- 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.
- Elevated blood pressure readings (screening test): i) age < 60 years: any history of hypertension; ii) age > 60 years: resting blood pressure reading higher than 150/90 mmHg.
- Cardiovascular diseases (self-report, screening tests, and clinician judgment):
- Congestive heart failure, pericardial effusion, coronary artery disease, mild valvular heart disease, congenital heart disease, significant arrhythmia(at rest or with exercise), stroke, or symptomatic peripheral artery disease (self-report, screening test) ii) Positive stress induced wall motion abnormalities.
- Unexplained syncope.
- Abnormal blood lipid profile (screening test): either fasting triglycerides >500 mg/dLand/or LDL cholesterol (LDL-C) >190mg/dL.
- History of cancer treatment (other than non-melanoma skin cancer) and not "cancer-free" for at least 2 years. Anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months.
- Chronic infection: i) infections requiring chronic antibiotic or anti-viral treatment; ii) Human Immunodeficiency Virus; iii) individuals successfully treated for hepatitis C and virologically negative for at least 6 months are not excluded.
- Liver enzyme tests (alanine transaminase, aspartate transaminase) (screening test) >2 times the laboratory upper limit of normal.
- Chronic renal insufficiency (screening test): estimated glomerular filtration rate <60 mL/min/1.73 m2 from serum creatinine (mg/dL) by the Chronic Kidney Disease Epidemiology Collaboration equation
- Hematocrit (screening) >3 points outside of the local normal laboratory ranges for women and men
- Whole blood donation in the last 3 months or plans for blood donation during the entire protocol period. Platelet or plasma donation in the last week or plans for platelet or plasma donation during the entire protocol period
- Individuals receiving any active treatment for autoimmune disorders (including monoclonal antibodies) within the last 6 months.
- Alcohol consumption (self-report): i) more than 7 drinks per week for women and more than 14 drinks per week for men; ii) history of binge drinking.
- Consume of tobacco, e-cigarette, nicotine products, and/or marijuana more than 3 days a week.
- Shift workers: night shift work in the last 6 months or planning night shift work during the study period.
- Hospitalization for any psychiatric condition within one year (self-report).
- Weight change (intentional or not) over the last 6 months of >5% of body weight or plan to lose or gain weight during the study.
- Inflammatory conditions including rheumatoid arthritis, inflammatory bowel disease, connective tissue disease including lupus, systemic lupus.
- Any musculoskeletal or ligamentous injury, amputation or congenital neurological defect that, in the opinion of the team clinician, would negatively impact or mitigate participation in and completion of the protocol.
- Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric or other conditions that, in the opinion of the team clinician, would preclude participation and successful completion of the protocol. Any other blood tests value outside of normal range if that indicates a condition that might preclude participation in the study.
- Mental incapacity and/or cognitive impairment on the part of the participant that would inhibit adequate understanding of or cooperation with the study protocol.
- EXCLUSIONS FOR MEDICATION USE:
- Use of any new drug in the last 3 months or dose change for any drug in the last within 3 months
- Participants will be excluded if they are taking any of the medication listed below:
- Anticoagulants Antiarrhythmics Antiplatelet drugs (other than aspirin <100 mg/day) Beta blockers Lipid-lowering medications Chronic use of medium- or long-acting sedatives and hypnotics (short-acting non-benzodiazepine sedative-hypnotics are allowed) Two or more drugs for depression Mood stabilizers Antiepileptic drugs Stimulants, Attention-Deficit/Hyperactivity Disorder (ADHD) drugs Anti-psychotic drugs Muscle relaxants Chronic oral steroids Burst/taper oral steroids more than once in the last 12 months B2-agonists, allowed if on stable dose at least 3 months 5-alpha reductase inhibitors Daily phosphodiesterase type 5 inhibitor use Androgenic anabolic steroids, anti-estrogens, anti-androgens Growth hormone, insulin like growth factor-I, growth hormone releasing hormone Any drugs used to treat diabetes mellitus or to lower blood glucose Any drugs used specifically to induce weight loss Any drugs used specifically to induce muscle growth/hypertrophy or augment exercise-induced muscle hypertrophy Narcotics and narcotic receptor agonists Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen more than 3 days a week Anti-malarials High-potency topical steroids Continuous use of antibiotics or other anti-infectives Monoclonal antibodies Any other medications that, in the opinion of local clinicians, would negatively impact or mitigate full participation and completion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University
Stanford, California, 94305-2200
About this study
Official title: Physiological and Molecular Effects of High-intensity Interval Training (HIIT) vs. Moderate-intensity Continuous Training (MICT)
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.
- Being tested
- Exercise intervention
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionOther
12 weeks of exercise training, 3 times per week, ~1h long
| Study group | Role | What they receive |
|---|---|---|
| HIIT group | Experimental | Participants randomized in this group will be assigned to 12 weeks high intensity interval training. Receives: Other: Exercise intervention |
| MICT group | Experimental | Participants randomized in this group will be assigned to 12 weeks of moderate-intensity continuous training. Receives: Other: Exercise intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Exercise Testing
Change in VO2 max after training, measured during cardiopulmonary exercise testing
Measured: Baseline; 12 weeks
Clinical markers
Changes in measured lipids in mg/dL including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
Measured: Baseline; 12 weeks
Transcriptome after 12-week intervention
Change in mRNA-based expression measured in biospecimens after 12 weeks of training
Measured: Baseline; 12 weeks
Proteome after 12-week intervention
Change in protein measured in biospecimens after 12 weeks of training
Measured: Baseline; 12 weeks
Metabolome after 12-week intervention
Change in metabolites measured in biospecimens after 12 weeks of training
Measured: Baseline; 12 weeks
Lipidome after 12-week intervention
Change in lipids measured in biospecimens after 12 weeks of training
Measured: Baseline; 12 weeks
Epigenome after 12-week intervention
Change in epigenome measured in biospecimens after 12 weeks of training
Measured: Baseline; 12 weeks
Secondary outcomes (20)
Transcriptome after acute exercise
Change in mRNA-based expression measured in biospecimens after acute exercise tests
Measured: Baseline; 12 weeks
Proteome after acute exercise
Change in protein measured in biospecimens after acute exercise tests
Measured: Baseline; 12 weeks
Metabolome after acute exercise
Change in metabolites measured in biospecimens after acute exercise tests
Measured: Baseline; 12 weeks
Lipidome after acute exercise
Change in lipids measured in biospecimens after acute exercise tests
Measured: Baseline; 12 weeks
Epigenome after acute exercise
Change in epigenome measured in biospecimens after acute exercise tests
Measured: Baseline; 12 weeks
Lean muscle mass
Change in lean muscle mass in kg measured by dual-energy x-ray absorptiometry
Measured: Baseline; 12 weeks
Fat mass
Change in fat mass in kg measured by dual-energy x-ray absorptiometry
Measured: Baseline; 12 weeks
Leg strength
Change in leg strength measured by Biodex
Measured: Baseline; 12 weeks
Hand grip strength
Change in hand grip strength measured by Biodex
Measured: Baseline; 12 weeks
Resting heart rate
Change in resting heart rate measured by wearable devices
Measured: Baseline; 12 weeks
Metagenome profile
Change in metagenome profile from stool microbiome kit
Measured: Baseline; 12 weeks
Blood glucose
Change in blood glucose in mg/dl profile measured with continuous glucose monitor
Measured: Baseline; 12 weeks
Left ventricle (LV) mass
Change in left ventricle mass measured by echocardiogram
Measured: Baseline; 12 weeks
LV diastolic volume
Change in LV diastolic volume measured by echocardiogram
Measured: Baseline; 12 weeks
Ejection fraction
Change in ejection fraction measured by echocardiogram
Measured: Baseline; 12 weeks
Exercise Motivation
Change in exercise motivation level measured by motivation for physical activity (RM 4-FM) questionnaire. RM 4-FM scores four different dimensions of motivation, each on a 0-7 point composite scale, with higher scores indicating stronger motivation.
Measured: Baseline; 12 weeks
Exercise Self-Efficacy
Change in exercise self-efficacy measured by Exercise Self Efficacy questionnaire, , a 9-item scale providing a 9-28 point composite score, with higher scores indicating higher self-efficacy for exercise.
Measured: Baseline; 12 weeks
Depression
Change in depression presence and/or severity measured by Patient Health Questionnaire-8, an 8-item scale providing a 0-24 point composite score, with higher scores indicating greater severity.
Measured: Baseline; Week 4, 8, 12
Generalized Anxiety
Change in anxiety presence and/or severity measured by Generalized Anxiety Disorder-7 , a 7-item scale providing a 0-21 point composite score, with higher scores indicating greater anxiety.
Measured: Baseline; Week 4, 8, 12
Perceived Stress
Change in perceived stress measured by Perceived Stress Scale-10, a 10-item scale providing a 0-40 point composite score, with higher scores indicating greater perceived stress.
Measured: Baseline; Week 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start10 Jan 2023
- Primary completion11 Aug 2025
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LifestyleStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francois Haddad, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513300
- Sponsor's protocol ID
- 64208
- Status last verified
- Oct 2026
- First submitted
- 19 Jul 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Molecular Effects of High-intensity Interval Training (HIIT) vs. Moderate-intensity Continuous Training (MICT)
- ClinicalTrials.gov ID
- NCT05513300
- Acronym / sponsor ID
- 64208
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIIT group | Experimental | Other: Exercise interventionParticipants randomized in this group will be assigned to 12 weeks high intensity interval training. |
| MICT group | Experimental | Other: Exercise interventionParticipants randomized in this group will be assigned to 12 weeks of moderate-intensity continuous training. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (35 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise intervention12 weeks of exercise training, 3 times per week, ~1h long | Other | HIIT group, MICT group |
Primary outcome
Cardiopulmonary Exercise Testing
Time frame: Baseline; 12 weeks
Change in VO2 max after training, measured during cardiopulmonary exercise testing
Clinical markers
Time frame: Baseline; 12 weeks
Changes in measured lipids in mg/dL including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
Transcriptome after 12-week intervention
Time frame: Baseline; 12 weeks
Change in mRNA-based expression 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
Metabolome after 12-week intervention
Time frame: Baseline; 12 weeks
Change in metabolites measured in biospecimens after 12 weeks of training
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
20 secondary outcomes
Transcriptome after acute exercise
Time frame: Baseline; 12 weeks
Proteome after acute exercise
Time frame: Baseline; 12 weeks
Metabolome after acute exercise
Time frame: Baseline; 12 weeks
Lipidome after acute exercise
Time frame: Baseline; 12 weeks
Epigenome after acute exercise
Time frame: Baseline; 12 weeks
Lean muscle mass
Time frame: Baseline; 12 weeks
Fat mass
Time frame: Baseline; 12 weeks
Leg strength
Time frame: Baseline; 12 weeks
Hand grip strength
Time frame: Baseline; 12 weeks
Resting heart rate
Time frame: Baseline; 12 weeks
Metagenome profile
Time frame: Baseline; 12 weeks
Blood glucose
Time frame: Baseline; 12 weeks
Left ventricle (LV) mass
Time frame: Baseline; 12 weeks
LV diastolic volume
Time frame: Baseline; 12 weeks
Ejection fraction
Time frame: Baseline; 12 weeks
Exercise Motivation
Time frame: Baseline; 12 weeks
Exercise Self-Efficacy
Time frame: Baseline; 12 weeks
Depression
Time frame: Baseline; Week 4, 8, 12
Generalized Anxiety
Time frame: Baseline; Week 4, 8, 12
Perceived Stress
Time frame: Baseline; Week 4, 8, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Lifestyle
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Active, not recruiting
Testing Counseling and Mobile Health Interventions to Improve Physical Activity and Diet Quality in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Recruiting
Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy
Microbiome
Recruiting
Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
Major Depressive Disorder (MDD)
Enrolling by invitationObservational study
NutFinForce - Lifestyle Performance Medicine Intervention on Defense Performance in Finland
No Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Lifestyle and Sedentary, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary Exercise Testing (time frame: Baseline; 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.