Exercise and Nutrition on Obese Microbiome
3. Januar 2020 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
31
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Florida
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Miami, Florida, Vereinigte Staaten, 33146
- University of Miami
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Experimental: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in fecal microbiota diversity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Wesley Smith, Ph.D., University of Miami
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
21. Oktober 2019
Primärer Abschluss (Tatsächlich)
21. Dezember 2019
Studienabschluss (Tatsächlich)
21. Dezember 2019
Studienanmeldedaten
Zuerst eingereicht
22. Oktober 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. Oktober 2019
Zuerst gepostet (Tatsächlich)
24. Oktober 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
7. Januar 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Januar 2020
Zuletzt verifiziert
1. Januar 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 20190936
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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