Heat Therapy and Omega 3 on Cardio-Metabolic Health

NCT04051034 | Unknown

• 1 other identifier: IRB2018-1199
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Metabolic flexibility

  Mixed meal tolerance test

  Change from baseline to 12 week metabolic flexibility

• Microbiome

  Stool microbiome diversity

  Change from baseline to 12 week in the phyla, genus and species of gut bacteria

• Short chain fatty acids

  Stool Short chain fatty acids

  Change from baseline to 12 week short chain fatty acids, acetate, propionate, and butyrate (C4).

• Vascular Health

  Brachial and skin flow mediated dilation

  Change from baseline to 12 week vessel function

Study Arms (2)

Omega 3 supplementation

EXPERIMENTAL

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..

Dietary Supplement: Omega 3

Placebo

EXPERIMENTAL

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..

Other: Placebo

Interventions

Omega 3 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 \[1.25-gram high oleic safflower oil capsule\]

Also known as: Organic Technologies

Omega 3 supplementation

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI\>30-40,
• fasting glucose 100-125,
• blood pressure 130-139/80-89,
• Hispanic American,
• age 18-65 years

You may not qualify if:

• non-Hispanic,
• BMI\<30, \>40,
• fasting glucose \<100, \>125,
• blood pressure \<130,\>139 systolic, \>90 diastolic,
• age \<18, \>65 years

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Eric Rivas

Lubbock, Texas, 79424, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

Eric Rivas, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo or Omega 3 supplementation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: August 9, 2019
• Study Start: August 20, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)