Exercise and Nutrition on Obese Microbiome
2020년 1월 3일 업데이트: Wesley Smith, University of Miami
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
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.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
31
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Miami, Florida, 미국, 33146
- University of Miami
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion criteria:
- 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.
Exclusion criteria:
1. Any subjects who do not meet all of the inclusion criteria and/or are unable to consent.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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The exercise protocol consists of a nine-week progressive intense-conditioning program involving six consecutive days (Monday-Saturday) of one-hour exercises and one-day rest weekly for a total of 54 days of exercise.
Exercises are performed in person as a group with other participating subjects and lead by certified instructors.
Exercises will involve a variety of activities ranging from running, cycling, whole-body functional movements, power movements, and open-chain weight lifting with barbells and resistance bands.
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실험적: Exercise with CR-LC Group
Participants will receive the exercise protocol and CR-LC Diet regimen.
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The exercise protocol consists of a nine-week progressive intense-conditioning program involving six consecutive days (Monday-Saturday) of one-hour exercises and one-day rest weekly for a total of 54 days of exercise.
Exercises are performed in person as a group with other participating subjects and lead by certified instructors.
Exercises will involve a variety of activities ranging from running, cycling, whole-body functional movements, power movements, and open-chain weight lifting with barbells and resistance bands.
Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks.
CR-LC consists of caloric and macronutrient restrictions.
Caloric restrictions involves a 40% deficit from calculated total daily energy expenditure.
Macronutrient restriction involves a high protein, low carbohydrate diet (35% protein, 25% carbohydrate and 40% fat).
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실험적: Exercise with Ancestral Diet (AD) Group
Participants will receive the exercise protocol and AD regimen.
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The exercise protocol consists of a nine-week progressive intense-conditioning program involving six consecutive days (Monday-Saturday) of one-hour exercises and one-day rest weekly for a total of 54 days of exercise.
Exercises are performed in person as a group with other participating subjects and lead by certified instructors.
Exercises will involve a variety of activities ranging from running, cycling, whole-body functional movements, power movements, and open-chain weight lifting with barbells and resistance bands.
Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks.
AD consists of consuming only whole foods and avoiding processed foods.
Emphasis will be on food quality with no caloric or macronutrient restrictions.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in fecal microbiota diversity
기간: Baseline, 9 weeks
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Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation
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Baseline, 9 weeks
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Change in Bacteriodetes/Firmicutes ratio
기간: Baseline, 9 weeks
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Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation
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Baseline, 9 weeks
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Percent change in fecal microbiota composition
기간: Baseline, 9 weeks
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Percent change in Bacteriodetes phyla and percent change of short-chain fatty acid-producing species as assessed via stool sample evaluation
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Baseline, 9 weeks
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Change in inflammatory markers
기간: Baseline, 9 weeks
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Change in serum inflammatory markers including Interleukin (IL)-1ß, IL-6, Tumor Necrosis Factor (TNF)-α and liposaccharide (LPS) evaluated in pg/ml.
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Baseline, 9 weeks
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Change in leptin/adiponectin ratio
기간: Baseline, 9 weeks
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Change in serum adipose markers assessed as change in leptin/adiponectin ratio.
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Baseline, 9 weeks
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Correlation of serum triglycerides with leptin levels
기간: Baseline, 9 weeks
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The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.
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Baseline, 9 weeks
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Change in body weight
기간: Baseline, 9 weeks
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Change in body composition as evaluated as change in body weight measured in lbs.
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Baseline, 9 weeks
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Change in resting metabolic rate
기간: Baseline, 9 weeks
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Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.
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Baseline, 9 weeks
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Change in body composition
기간: Baseline, 9 weeks
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Change in body composition as evaluated as change in body fat and lean body mass percentage
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Baseline, 9 weeks
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Change in waist circumference
기간: Baseline, 9 weeks
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Change in waist circumference measured in inches.
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Baseline, 9 weeks
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Change in blood pressure
기간: Baseline, 9 weeks
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Change in blood pressure assessed as systolic and diastolic pressure in mmHg.
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Baseline, 9 weeks
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Change in visceral fat
기간: Baseline, 9 weeks
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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).
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Baseline, 9 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Wesley Smith, Ph.D., University of Miami
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 10월 21일
기본 완료 (실제)
2019년 12월 21일
연구 완료 (실제)
2019년 12월 21일
연구 등록 날짜
최초 제출
2019년 10월 22일
QC 기준을 충족하는 최초 제출
2019년 10월 22일
처음 게시됨 (실제)
2019년 10월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 1월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 1월 3일
마지막으로 확인됨
2020년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .