Hypertension
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTOmega 3
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 \[1.25-gram high oleic safflower oil capsule\]
OTHERPlacebo
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.
Sponsors
Texas Tech University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Placebo or Omega 3 supplementation
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic flexibility | Change from baseline to 12 week metabolic flexibility | Mixed meal tolerance test |
| Microbiome | Change from baseline to 12 week in the phyla, genus and species of gut bacteria | Stool microbiome diversity |
| Short chain fatty acids | Change from baseline to 12 week short chain fatty acids, acetate, propionate, and butyrate (C4). | Stool Short chain fatty acids |
| Vascular Health | Change from baseline to 12 week vessel function | Brachial and skin flow mediated dilation |
Countries
United States
Contacts
Primary ContactEric Rivas, Ph.D.
Outcome results
None listed