Hypertension (HTN)MIND HIITNCT07130539
Mediterranean-DASH Intervention for Neurodegenerative Delay and High-Intensity Interval Training in Adults With Hypertension
A study testing MIND HIIT in people with Hypertension (HTN) and Obesity &Amp; Overweight, run by Texas Woman's University at 1 site in United States.
Trial summary
This pilot study examines whether a 4-week diet and exercise intervention can improve blood pressure, heart health, and sleep in physically inactive individuals with high blood pressure and overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Hypertension (HTN), Obesity &Amp; Overweight, Sedentary
- What is being tested?
- MIND HIIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2025to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 74 years old
- BMI 25 - 39.9 kg/m2 (for measured BMI)
- Clinically diagnosed hypertension (physical medical record showing diagnosis of hypertension) with or without current medication use (SPB < 160 mm Hg, DBP < 100 mm Hg)
- Physically inactive < 7,500 steps per day (measured on Fitbit over 1-week)
- No current injury, illness, or joint issue that prevents participation in exercise
- Able to read and speak English
- Willingness to participate and give informed written consent
- Willingness to share medical record indicating diagnosis of HTN and current medication use
Who cannot join
- Pregnant, breastfeeding, lactating
- Current smoker
- Food allergy or lactose intolerance
- Height > 6 foot 6 inches (78 inches)
- Blood pressure ≥ 160/100 mm Hg (Contraindication to exercise testing)
- History of diagnosed cardiovascular diseases including heart attack, stroke, irregular heartbeat such as atrial fibrillation, coronary artery or peripheral artery disease, or heart failure
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- History of liver, kidney, or metabolic disease (including type I or II diabetes)
- History of cancer
- Diagnosed moderate to severe obstructive sleep apnea, CPAP use, insomnia, h/o other sleep disorder
- Night shift and/or rotating shift worker (current or in the past 2 years)
- Current use of sleep medications or sleep aids
- Excessive alcohol intake - ≥ 8 drinks per week in women, ≥ 15 drinks per week in men
- History of gastric bypass or other weight loss surgery
- Current use of metformin, insulin, dietary supplements or drugs for glycemic control or weight loss
- Weight stable for the last 2 months (< 5 pounds body weight change)
- Currently following a special diet for weight loss (Keto, Atkins, Intermittent Fasting)
- A "yes" response to any questions on the PAR-Q (excluding Question 6 on use of BP medications)
- Exercise training (≥ 2 days per week structured aerobic and resistance training at gym)
- Prior hospitalization for COVID-19
- Any medications or supplements that may alter study outcomes as determined by study PI
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Woman's University Houston Center
Houston, Texas, 77030
About this study
Official title: Mediterranean-DASH Intervention for Neurodegenerative Delay and High-Intensity Interval Training to Improve Blood Pressure and Other Cardiovascular Disease Risk Factors in Adults With Hypertension and Overweight/Obesity
This pilot study examines whether a 4-week diet and exercise intervention can improve blood pressure, heart health, and sleep in physically inactive individuals with high blood pressure and overweight or obesity.
- Conditions
- Hypertension (HTN), Obesity &Amp; Overweight, Sedentary
- Being tested
- MIND HIIT
- Keywords
- Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND), High-Intensity Interval Training (HIIT), Hypertension, Sleep, Nocturnal Blood Pressure, Ambulatory Blood Pressure Monitoring, Lifestyle Intervention, Overweight/Obesity, Cardiovascular Disease, Inflammation, Extra Virgin Olive Oil, Nuts
- Medical subject headings
- Hypertension, Obesity, Overweight, Sedentary Behavior, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIND HIITOther
4 week intervention consisting of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet in combination with 3 days per week of High-Intensity Interval Training (HIIT) exercise
| Study group | Role | What they receive |
|---|---|---|
| MIND Diet + High-Intensity Interval Training (HIIT) | Experimental | 4 week intervention consisting of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet and High-Intensity Interval Training (HIIT) Exercise Receives: Other: MIND HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT in adults with HTN and overweight/obesity.
Adherence to the lifestyle intervention will be determined by ≥ 75% supervised exercise training visits completed and ≥ 75% dietary compliance.
Measured: From baseline to end of treatment at 4 weeks
Secondary outcomes (6)
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to lower blood pressure in adults with HTN and overweight/obesity.
Clinic-based blood pressure will be measured in triplicate at each testing visit using a Welch Allyn Automated Blood Pressure Unit and 24-hour blood pressure will also be measured using SunTech Oscar 2 Ambulatory Blood Pressure Monitors
Measured: Baseline and end of intervention at 4 weeks
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve nocturnal blood pressure in adults with HTN and overweight/obesity.
Nocturnal blood pressure will be measured using SunTech Oscar 2 Ambulatory Blood Pressure Monitors
Measured: At baseline and at the end of the 4 week intervention
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve cardiorespiratory fitness in adults with HTN and overweight/obesity.
Cardiorespiratory fitness will be assessed via maximal oxygen uptake (VO2max) on a cycle ergometer
Measured: Baseline and end of intervention at 4 weeks
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve cardiometabolic blood biomarkers in adults with HTN and overweight/obesity.
Fasting blood will be drawn, processed, and analyzed for glucose, insulin, lipids, and inflammatory markers.
Measured: At baseline and end of the intervention at 4 weeks
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to lower visceral fat in adults with HTN and overweight/obesity.
Visceral fat will be measured via dual-energy x-ray absorptiometry (DEXA)
Measured: Baseline and end of intervention at 4 weeks
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve quality of life in adults with HTN and overweight/obesity.
Health-related quality of life will be measured with the 36-item Short-Form Health Survey (SF-36)
Measured: Baseline and at the end of the intervention at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start11 Mar 2025
- Primary completion23 Aug 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot/Feasibility Study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesley Tucker, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130539
- Sponsor's protocol ID
- IRB-FY2025-184
- Acronym
- MIND HIIT
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean-DASH Intervention for Neurodegenerative Delay and High-Intensity Interval Training to Improve Blood Pressure and Other Cardiovascular Disease Risk Factors in Adults With Hypertension and Overweight/Obesity
- ClinicalTrials.gov ID
- NCT07130539
- Acronym / sponsor ID
- MIND HIIT / IRB-FY2025-184
- Conditions
- Hypertension (HTN), Obesity &Amp; Overweight, Sedentary
- Keywords
- Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND), High-Intensity Interval Training (HIIT), Hypertension, Sleep, Nocturnal Blood Pressure, Ambulatory Blood Pressure Monitoring, Lifestyle Intervention, Overweight/Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 23 Aug 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 19 Aug 2025 (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.
This pilot study examines whether a 4-week diet and exercise intervention can improve blood pressure, heart health, and sleep in physically inactive individuals with high blood pressure and overweight or obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot/Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| MIND Diet + High-Intensity Interval Training (HIIT) | Experimental | Other: MIND HIIT4 week intervention consisting of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet and High-Intensity Interval Training (HIIT) Exercise |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 74 years old
- BMI 25 - 39.9 kg/m2 (for measured BMI)
- Clinically diagnosed hypertension (physical medical record showing diagnosis of hypertension) with or without current medication use (SPB < 160 mm Hg, DBP < 100 mm Hg)
- Physically inactive < 7,500 steps per day (measured on Fitbit over 1-week)
- No current injury, illness, or joint issue that prevents participation in exercise
Key exclusion criteria (20 listed)
- Pregnant, breastfeeding, lactating
- Current smoker
- Food allergy or lactose intolerance
- Height > 6 foot 6 inches (78 inches)
- Blood pressure ≥ 160/100 mm Hg (Contraindication to exercise testing)
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 |
|---|---|---|
| MIND HIIT4 week intervention consisting of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet in combination with 3 days per week of High-Intensity Interval Training (HIIT) exercise | Other | MIND Diet + High-Intensity Interval Training (HIIT) |
Primary outcome
To determine the feasibility of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT in adults with HTN and overweight/obesity.
Time frame: From baseline to end of treatment at 4 weeks
Adherence to the lifestyle intervention will be determined by ≥ 75% supervised exercise training visits completed and ≥ 75% dietary compliance.
6 secondary outcomes
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to lower blood pressure in adults with HTN and overweight/obesity.
Time frame: Baseline and end of intervention at 4 weeks
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve nocturnal blood pressure in adults with HTN and overweight/obesity.
Time frame: At baseline and at the end of the 4 week intervention
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve cardiorespiratory fitness in adults with HTN and overweight/obesity.
Time frame: Baseline and end of intervention at 4 weeks
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve cardiometabolic blood biomarkers in adults with HTN and overweight/obesity.
Time frame: At baseline and end of the intervention at 4 weeks
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to lower visceral fat in adults with HTN and overweight/obesity.
Time frame: Baseline and end of intervention at 4 weeks
To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve quality of life in adults with HTN and overweight/obesity.
Time frame: Baseline and at the end of the intervention at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication
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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 MIND HIIT in people with Hypertension (HTN) and Obesity &Amp; Overweight, run by Texas Woman's 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 8 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
To determine the feasibility of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT in adults with HTN and overweight/obesity. (time frame: From baseline to end of treatment at 4 weeks). 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 19 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.