Heat Therapy and Omega 3 on Cardio-Metabolic Health

Texas Tech University

Status: Unknown

Conditions: Hypertension

Treatments: Dietary Supplement: Omega 3; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04051034

IRB2018-1199

Details and patient eligibility

About

Currently, controlled studies are lacking which test the benefits of: 1) ω3 PUFA; and 2) heat therapy on improving vascular-metabolic-microbiota health in Hispanic American populations. The investigator's objective is to determine if this modality (heat therapy i.e., warm water immersion, hot tubs) combined with dietary interventions (increased fish and/or fish oil intake) may be feasible treatments to improve cardiovascular risk factors and reduced comorbidities in Hispanic populations.

Full description

In a double-blind, placebo-controlled design, participants will be randomized to the following experimental treatments:

1. 4 g omega 3 daily for 12 weeks combined with 6 weeks of heat therapy
2. Placebo pill daily for 12 weeks with 6 weeks of heat therapy (HT)

non-obese healthy will only serve as controls and enroll in placebo and neutral control therapy conditions.

HT will entail 14 consecutive days of 1.5 hours passive heating (increase internal temperature 1.2°C above baseline), followed by 4 weeks of HT, 3 days per week.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI>30-40,
• fasting glucose 100-125,
• blood pressure 130-139/80-89,
• Hispanic American,
• age 18-65 years

Exclusion criteria

• non-Hispanic,
• BMI<30, >40,
• fasting glucose <100, >125,
• blood pressure <130,>139 systolic, >90 diastolic,
• age <18, >65 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Omega 3 supplementation

Experimental group

Description:

12 weeks: Active: 1.25 g capsules/ \[1.25 g capsule contains min. 750 mg EPA + 250 mg DHA\] with heat therapy increasing internal body temperature 1.2C above baseline for 90 min each bout..

Treatment:

Dietary Supplement: Omega 3

Placebo

Experimental group

Description:

12 weeks: Placebo: 1.25 g capsules/ \[1.25-gram high oleic safflower oil capsule\]with heat therapy increasing internal body temperature 1.2C above baseline for 90 min each bout..

Treatment:

Other: Placebo