Heat Therapy and Omega 3 on Cardio-Metabolic Health

Study Overview
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Brief Summary
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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.

Detailed Description
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In a double-blind, placebo-controlled design, participants will be randomized to the following experimental treatments: 4 g omega 3 daily for 12 weeks combined with 6 weeks of heat therapy 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.

Official Title
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Heat Therapy and Omega 3 on Metabolic and Cardiovascular Health

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: Omega 3
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega 3 supplementation<br>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.. | Dietary Supplement: Omega 3<br>* Active: 1.25 g capsules/420 35-count bottles [1.25 g capsule contains min. 750 mg EPA + 250 mg DHA] and heat therapy, increase internal body temperature 1.2 C above baseline. Placebo: 14,700 1.25 g capsules/420 35-count bottles [1.25-gram high oleic safflower oil capsule]<br>* Other names: Organic Technologies;|
| Experimental: Placebo<br>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.. | Other: Placebo<br>* Active: 1.25 g capsules [1.25-gram high oleic safflower oil capsule] and heat therapy, increase internal body temperature 1.2 C above baseline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic flexibility | Mixed meal tolerance test | Change from baseline to 12 week metabolic flexibility | 
| Microbiome | Stool microbiome diversity | Change from baseline to 12 week in the phyla, genus and species of gut bacteria | 
| Short chain fatty acids | Stool Short chain fatty acids | Change from baseline to 12 week short chain fatty acids, acetate, propionate, and butyrate (C4). | 
| Vascular Health | Brachial and skin flow mediated dilation | Change from baseline to 12 week vessel function |