Exercise and Nutrition on Obese Microbiome
2020年1月3日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
31
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Florida
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Miami、Florida、アメリカ、33146
- University of Miami
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in fecal microbiota diversity
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Wesley Smith, Ph.D.、University of Miami
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年10月21日
一次修了 (実際)
2019年12月21日
研究の完了 (実際)
2019年12月21日
試験登録日
最初に提出
2019年10月22日
QC基準を満たした最初の提出物
2019年10月22日
最初の投稿 (実際)
2019年10月24日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月7日
QC基準を満たした最後の更新が送信されました
2020年1月3日
最終確認日
2020年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。