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

NCT07130539 | Active Not Recruiting

• 1 other identifier: IRB-FY2025-184
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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; Cardiovascular Disease; Inflammation; Extra Virgin Olive Oil; Nuts

Outcome Measures

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.

  Adherence to the lifestyle intervention will be determined by ≥ 75% supervised exercise training visits completed and ≥ 75% dietary compliance.

  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.

  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.

  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.

  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.

  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.

  Baseline and end of intervention at 4 weeks

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.

  At baseline and at the end of the 4 week intervention

Study Arms (1)

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

Other: MIND HIIT

Interventions

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

MIND Diet + High-Intensity Interval Training (HIIT)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

Texas Woman's University Houston Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypertension; Obesity; Overweight; Sedentary Behavior; Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Vascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nutrition

Model Details: Pilot/Feasibility Study

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: March 11, 2025
• Primary Completion: August 23, 2025
• Study Completion: December 25, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: July 2026 to July 2028
• Access Criteria: Email study PI

Locations

US (1)