Back to resultsHeat Therapy and Omega 3 on Cardio-Metabolic Health
Primary Purpose
Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega 3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
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
Sites / Locations
- Eric RivasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Omega 3 supplementation
Placebo
Arm Description
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..
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..
Outcomes
Primary Outcome Measures
Metabolic flexibility
Mixed meal tolerance test
Microbiome
Stool microbiome diversity
Short chain fatty acids
Stool Short chain fatty acids
Vascular Health
Brachial and skin flow mediated dilation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04051034
Brief Title
Heat Therapy and Omega 3 on Cardio-Metabolic Health
Official Title
Heat Therapy and Omega 3 on Metabolic and Cardiovascular Health
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2019 (Anticipated)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Placebo or Omega 3 supplementation
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omega 3 supplementation
Arm Type
Experimental
Arm Description
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..
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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..
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega 3
Other Intervention Name(s)
Organic Technologies
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
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 Information:
Title
Metabolic flexibility
Description
Mixed meal tolerance test
Time Frame
Change from baseline to 12 week metabolic flexibility
Title
Microbiome
Description
Stool microbiome diversity
Time Frame
Change from baseline to 12 week in the phyla, genus and species of gut bacteria
Title
Short chain fatty acids
Description
Stool Short chain fatty acids
Time Frame
Change from baseline to 12 week short chain fatty acids, acetate, propionate, and butyrate (C4).
Title
Vascular Health
Description
Brachial and skin flow mediated dilation
Time Frame
Change from baseline to 12 week vessel function
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Rivas, Ph.D.
Phone
806-834-8563
Email
eric.rivas@ttu.edu
Facility Information:
Facility Name
Eric Rivas
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Rivas, Ph.D.
Phone
806-834-8563
Ext
8068348563
Email
eric.rivas@ttu.edu
First Name & Middle Initial & Last Name & Degree
Eric Rivas
Phone
8068348563
Ext
8068348563
Email
eric.rivas@ttu.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Heat Therapy and Omega 3 on Cardio-Metabolic Health
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