The Effects of a Calorie-Restrictive Low-Carbohydrate Diet Versus an Unrestrictive Ancestral Diet on Microbiota and Cardiometabolic Disease Markers of Obese Individuals Performing an Intense Exercise Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in visceral fat
研究概览
简要总结
The purpose of this study is to examine the effects nine weeks of intense exercise training will have on weight, inflammation, and intestinal bacteria composition of overweight and obese adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- 否
入选标准
- •Individuals who are overweight (BMI ≥ 25) and/or obese (BMI ≥ 30).
- •Individuals who volunteer for the 54-day exercise program.
- •Individuals with no history of diabetes mellitus (type I or II) or sickle cell disease.
- •Individuals who are not taking antibiotics and have not taken antibiotics within 3 months.
- •Individuals who are not taking probiotics.
- •Individuals who are not taking Metformin.
- •Individuals who are cleared by their physician to perform strenuous exercise.
- •Individuals with no physically debilitating injuries that would keep them from being able to perform the exercises prescribed.
- •Individuals who are between 18 and 60.
排除标准
- •Any subjects who do not meet all of the inclusion criteria and/or are unable to consent.
研究组 & 干预措施
Exercise with Ancestral Diet (AD) Group
Participants will receive the exercise protocol and AD regimen.
干预措施: Exercise Protocol (Other)
Exercise with Ancestral Diet (AD) Group
Participants will receive the exercise protocol and AD regimen.
干预措施: Ancestral Diet (AD) (Other)
Exercise Only Group (EX)
Participants will only receive the exercise protocol without nutrition education or counseling and instructed to continue to consume their regular diet.
干预措施: Exercise Protocol (Other)
Exercise with CR-LC Group
Participants will receive the exercise protocol and CR-LC Diet regimen.
干预措施: Exercise Protocol (Other)
Exercise with CR-LC Group
Participants will receive the exercise protocol and CR-LC Diet regimen.
干预措施: Calorie-Restrictive Low Carbohydrate Diet (CR-LC) (Other)
结局指标
主要结局
Change in visceral fat
时间窗: Baseline, 9 weeks
Change in visceral fat levels will be measured using InBody570 with scores ranging from 1-20, with the higher score indicating increased visceral fat (worse outcome).
Correlation of serum triglycerides with leptin levels
时间窗: Baseline, 9 weeks
The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.
Change in Bacteriodetes/Firmicutes ratio
时间窗: Baseline, 9 weeks
Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation
Percent change in fecal microbiota composition
时间窗: Baseline, 9 weeks
Percent change in Bacteriodetes phyla and percent change of short-chain fatty acid-producing species as assessed via stool sample evaluation
Change in body weight
时间窗: Baseline, 9 weeks
Change in body composition as evaluated as change in body weight measured in lbs.
Change in waist circumference
时间窗: Baseline, 9 weeks
Change in waist circumference measured in inches.
Change in fecal microbiota diversity
时间窗: Baseline, 9 weeks
Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation
Change in leptin/adiponectin ratio
时间窗: Baseline, 9 weeks
Change in serum adipose markers assessed as change in leptin/adiponectin ratio.
Change in resting metabolic rate
时间窗: Baseline, 9 weeks
Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.
Change in blood pressure
时间窗: Baseline, 9 weeks
Change in blood pressure assessed as systolic and diastolic pressure in mmHg.
Change in inflammatory markers
时间窗: Baseline, 9 weeks
Change in serum inflammatory markers including Interleukin (IL)-1ß, IL-6, Tumor Necrosis Factor (TNF)-α and liposaccharide (LPS) evaluated in pg/ml.
Change in body composition
时间窗: Baseline, 9 weeks
Change in body composition as evaluated as change in body fat and lean body mass percentage
次要结局
未报告次要终点
研究者
Wesley Smith
Assistant Professor
University of Miami