HypertensionNCT04051034
Heat Therapy and Omega 3 on Cardio-Metabolic Health
A study testing Omega 3 in people with Hypertension, run by Texas Tech University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Omega 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI>30-40,
- fasting glucose 100-125,
- blood pressure 130-139/80-89,
- Hispanic American,
- age 18-65 years
Who cannot join
- non-Hispanic,
- BMI<30, >40,
- fasting glucose <100, >125,
- blood pressure <130,>139 systolic, >90 diastolic,
- age <18, >65 years
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Eric Rivas
Lubbock, Texas, 79424
Eric Rivas, Ph.D., 806-834-8563 ext. 8068348563, eric.rivas@ttu.edu
Eric Rivas, 8068348563 ext. 8068348563, eric.rivas@ttu.edu
About this study
Official title: Heat Therapy and Omega 3 on Metabolic and Cardiovascular Health
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.
Read the detailed description
In a double-blind, placebo-controlled design, participants will be randomized to the following experimental treatments:
- 4 g omega 3 daily for 12 weeks combined with 6 weeks of heat therapy
- 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
- Hypertension
- Being tested
- Omega 3, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3Dietary supplement
Also called Organic Technologies
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]
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.. Receives: 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.. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic flexibility
Mixed meal tolerance test
Measured: Change from baseline to 12 week metabolic flexibility
Microbiome
Stool microbiome diversity
Measured: Change from baseline to 12 week in the phyla, genus and species of gut bacteria
Short chain fatty acids
Stool Short chain fatty acids
Measured: Change from baseline to 12 week short chain fatty acids, acetate, propionate, and butyrate (C4).
Vascular Health
Brachial and skin flow mediated dilation
Measured: Change from baseline to 12 week vessel function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start20 Aug 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Rivas, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051034
- Sponsor's protocol ID
- IRB2018-1199
- Status last verified
- Aug 2019
- First submitted
- 24 Jul 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Therapy and Omega 3 on Metabolic and Cardiovascular Health
- ClinicalTrials.gov ID
- NCT04051034
- Acronym / sponsor ID
- IRB2018-1199
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 20 Aug 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 4 g omega 3 daily for 12 weeks combined with 6 weeks of heat therapy
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 supplementation | Experimental | Dietary Supplement: Omega 312 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.. |
| Placebo | Experimental | Other: Placebo12 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.. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI>30-40,
- fasting glucose 100-125,
- blood pressure 130-139/80-89,
- Hispanic American,
- age 18-65 years
Key exclusion criteria (5 listed)
- non-Hispanic,
- BMI<30, >40,
- fasting glucose <100, >125,
- blood pressure <130,>139 systolic, >90 diastolic,
- age <18, >65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3Also: Organic TechnologiesActive: 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] | Dietary supplement | Omega 3 supplementation |
| PlaceboActive: 1.25 g capsules [1.25-gram high oleic safflower oil capsule] and heat therapy, increase internal body temperature 1.2 C above baseline. | Other | Placebo |
Primary outcome
Metabolic flexibility
Time frame: Change from baseline to 12 week metabolic flexibility
Mixed meal tolerance test
Microbiome
Time frame: Change from baseline to 12 week in the phyla, genus and species of gut bacteria
Stool microbiome diversity
Short chain fatty acids
Time frame: Change from baseline to 12 week short chain fatty acids, acetate, propionate, and butyrate (C4).
Stool Short chain fatty acids
Vascular Health
Time frame: Change from baseline to 12 week vessel function
Brachial and skin flow mediated dilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 in people with Hypertension, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Rivas, Ph.D. (806-834-8563, eric.rivas@ttu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic flexibility (time frame: Change from baseline to 12 week metabolic flexibility). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.