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

NCT ID: NCT07130539

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2025-12-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MIND Diet + High-Intensity Interval Training (HIIT)

4 week intervention consisting of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet and High-Intensity Interval Training (HIIT) Exercise

Group Type: EXPERIMENTAL

MIND HIIT

Intervention Type: 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

Interventions

MIND HIIT

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Woman's University

OTHER

Sponsor Role: lead

Responsible Party

Wesley Tucker

Associate Professor of Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Texas Woman's University Houston Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB-FY2025-184

Identifier Type: -

Identifier Source: org_study_id