Heat Therapy and Omega 3 on Cardio-Metabolic Health

Hypertension Clinical Trial

Official title:

Heat Therapy and Omega 3 on Metabolic and Cardiovascular Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04051034
• Other study ID #: IRB2018-1199
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2019
• Source: Texas Tech University
• Contact: Eric Rivas, Ph.D.
• Phone: 806-834-8563
• Email: eric.rivas[@]ttu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• Omega 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]

Other:
• Placebo
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.

Locations

Country	Name	City	State
United States	Eric Rivas	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

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