Heat Therapy and Omega 3 on Metabolic and Cardiovascular Health
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Short chain fatty acids
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Placebo or Omega 3 supplementation
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI>30-40,
- •fasting glucose 100-125,
- •blood pressure 130-139/80-89,
- •Hispanic American,
- •age 18-65 years
排除标准
- •non-Hispanic,
- •BMI<30, >40,
- •fasting glucose <100, >125,
- •blood pressure <130,>139 systolic, >90 diastolic,
- •age <18, >65 years
研究组 & 干预措施
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..
干预措施: Placebo (Other)
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..
干预措施: Omega 3 (Dietary Supplement)
结局指标
主要结局
Short chain fatty acids
时间窗: Change from baseline to 12 week short chain fatty acids, acetate, propionate, and butyrate (C4).
Stool Short chain fatty acids
Metabolic flexibility
时间窗: Change from baseline to 12 week metabolic flexibility
Mixed meal tolerance test
Microbiome
时间窗: Change from baseline to 12 week in the phyla, genus and species of gut bacteria
Stool microbiome diversity
Vascular Health
时间窗: Change from baseline to 12 week vessel function
Brachial and skin flow mediated dilation
次要结局
未报告次要终点
研究者
Eric Rivas
Assistant Professor
Texas Tech University