Heat Therapy and Omega 3 on Cardio-Metabolic Health

NCT ID: NCT04051034

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2020-08-01

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:

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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Placebo or Omega 3 supplementation

Study Groups

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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..

Group Type EXPERIMENTAL

Omega 3

Intervention Type DIETARY_SUPPLEMENT

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

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..

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

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.

Interventions

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Other Intervention Names

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Organic Technologies

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

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Eric Rivas

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eric Rivas

Lubbock, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eric Rivas, Ph.D.

Role: CONTACT

806-834-8563

Facility Contacts

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Eric Rivas, Ph.D.

Role: primary

806-834-8563 ext. 8068348563

Eric Rivas

Role: backup

8068348563 ext. 8068348563

Other Identifiers

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IRB2018-1199

Identifier Type: -

Identifier Source: org_study_id

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