Heat Therapy and Omega 3 on Cardio-Metabolic Health

Not Applicable

• Conditions: Hypertension
• Interventions: Other: Placebo; Dietary Supplement: Omega 3

• Registration Number: NCT04051034
• Lead Sponsor: Texas Tech University

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.

Study Timeline

• Study First Submitted: 2019-07-24
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-09
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14
• Study Start: 2019-08-20
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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..
Omega 3 supplementation	Omega 3	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..

Primary Outcome Measures

Name	Time	Method
Short chain fatty acids	Change from baseline to 12 week short chain fatty acids, acetate, propionate, and butyrate (C4).	Stool Short chain fatty acids
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
Vascular Health	Change from baseline to 12 week vessel function	Brachial and skin flow mediated dilation

Trial Locations

Locations (1)

Eric Rivas; 🇺🇸 Lubbock, Texas, United States