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Active, Not Recruiting

NCT Number: NCT07130539

Mediterranean-DASH Intervention for Neurodegenerative Delay and High-Intensity Interval Training in Adults With Hypertension

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Woman's University Houston Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

MIND HIIT

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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

  2. 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

    Nocturnal blood pressure will be measured using SunTech Oscar 2 Ambulatory Blood Pressure Monitors

  3. 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

    Cardiorespiratory fitness will be assessed via maximal oxygen uptake (VO2max) on a cycle ergometer

  4. 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

    Fasting blood will be drawn, processed, and analyzed for glucose, insulin, lipids, and inflammatory markers.

  5. 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

    Visceral fat will be measured via dual-energy x-ray absorptiometry (DEXA)

  6. 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

    Health-related quality of life will be measured with the 36-item Short-Form Health Survey (SF-36)

Other outcomes

  1. To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve sleep quality in adults with HTN and overweight/obesity.

    Time frame: At baseline and at the end of the 4 week intervention

    Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) and Fitbit Inspire 3 trackers.

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Registry information

Official study 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

Acronym: MIND HIIT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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