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

Not Applicable

Active, not recruiting

• Conditions: Hypertension (HTN); Obesity &Amp; Overweight; Sedentary

• Registration Number: NCT07130539
• Lead Sponsor: Texas Woman's University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-11
• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Primary Completion: 2025-08-23
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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.	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
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.	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
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.	Baseline and end of intervention at 4 weeks	Cardiorespiratory fitness will be assessed via maximal oxygen uptake (VO2max) on a cycle ergometer
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.	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.
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.	Baseline and end of intervention at 4 weeks	Visceral fat will be measured via dual-energy x-ray absorptiometry (DEXA)
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.	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)

Trial Locations

Locations (1)

Texas Woman's University Houston Center; 🇺🇸 Houston, Texas, United States