Recruiting

Heat Therapy & Omega 3

Sponsor:

Texas Tech University

Code:

NCT04051034

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Omega 3

Placebo

Study Details

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.

Conditions

Hypertension

Study ID

NCT04051034

Start date

Aug 20, 2019

Status verified date

Aug, 2019

Completion date

Aug 1, 2020

Anticipated

Primary completion date

Aug 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Omega 3 supplementation

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..

experimental: 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..

Interventions

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 \[1.25-gram high oleic safflower oil capsule\]

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.

Primary outcome measure

  • Metabolic flexibility [ Time Frame: Change from baseline to 12 week metabolic flexibility ]
  • Microbiome [ Time Frame: Change from baseline to 12 week in the phyla, genus and species of gut bacteria ]
  • Short chain fatty acids [ Time Frame: Change from baseline to 12 week short chain fatty acids, acetate, propionate, and butyrate (C4). ]
  • Vascular Health [ Time Frame: Change from baseline to 12 week vessel function ]

Central Contacts and Locations

Central contacts

Eric Rivas, Ph.D.

806-834-8563eric.rivas@ttu.edu

Locations

Eric Rivas

Recruiting

Lubbock, Texas, United States, 79424

Contacts

Eric Rivas, Ph.D.

806-834-8563eric.rivas@ttu.edu

Eric Rivas

8068348563eric.rivas@ttu.edu

More Information

Sponsor

Texas Tech University

Last update posted

Aug 14, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Tech University on 2019-08-14.