Trials / Unknown
UnknownNCT04051034
Heat Therapy and Omega 3 on Cardio-Metabolic Health
Heat Therapy and Omega 3 on Metabolic and Cardiovascular Health
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Texas Tech University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-08-20
- Primary completion
- 2020-08-01
- Completion
- 2020-08-01
- First posted
- 2019-08-09
- Last updated
- 2019-08-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04051034. Inclusion in this directory is not an endorsement.