Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Exercise and Nutrition on Obese Microbiome

3. januar 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33146
        • University of Miami

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  1. Individuals who are overweight (BMI ≥ 25) and/or obese (BMI ≥ 30).
  2. Individuals who volunteer for the 54-day exercise program.
  3. Individuals with no history of diabetes mellitus (type I or II) or sickle cell disease.
  4. Individuals who are not taking antibiotics and have not taken antibiotics within 3 months.
  5. Individuals who are not taking probiotics.
  6. Individuals who are not taking Metformin.
  7. Individuals who are cleared by their physician to perform strenuous exercise.
  8. Individuals with no physically debilitating injuries that would keep them from being able to perform the exercises prescribed.
  9. 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Exercise Protocol
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.
Eksperimentel: Exercise with CR-LC Group
Participants will receive the exercise protocol and CR-LC Diet regimen.
Andet: Exercise Protocol
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.
Andet: Calorie-Restrictive Low Carbohydrate Diet (CR-LC)
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).
Eksperimentel: Exercise with Ancestral Diet (AD) Group
Participants will receive the exercise protocol and AD regimen.
Andet: Exercise Protocol
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.
Andet: Ancestral Diet (AD)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in fecal microbiota diversity
Tidsramme: Baseline, 9 weeks
Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation
Baseline, 9 weeks
Change in Bacteriodetes/Firmicutes ratio
Tidsramme: Baseline, 9 weeks
Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation
Baseline, 9 weeks
Percent change in fecal microbiota composition
Tidsramme: Baseline, 9 weeks
Percent change in Bacteriodetes phyla and percent change of short-chain fatty acid-producing species as assessed via stool sample evaluation
Baseline, 9 weeks
Change in inflammatory markers
Tidsramme: 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.
Baseline, 9 weeks
Change in leptin/adiponectin ratio
Tidsramme: Baseline, 9 weeks
Change in serum adipose markers assessed as change in leptin/adiponectin ratio.
Baseline, 9 weeks
Correlation of serum triglycerides with leptin levels
Tidsramme: Baseline, 9 weeks
The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.
Baseline, 9 weeks
Change in body weight
Tidsramme: Baseline, 9 weeks
Change in body composition as evaluated as change in body weight measured in lbs.
Baseline, 9 weeks
Change in resting metabolic rate
Tidsramme: Baseline, 9 weeks
Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.
Baseline, 9 weeks
Change in body composition
Tidsramme: Baseline, 9 weeks
Change in body composition as evaluated as change in body fat and lean body mass percentage
Baseline, 9 weeks
Change in waist circumference
Tidsramme: Baseline, 9 weeks
Change in waist circumference measured in inches.
Baseline, 9 weeks
Change in blood pressure
Tidsramme: Baseline, 9 weeks
Change in blood pressure assessed as systolic and diastolic pressure in mmHg.
Baseline, 9 weeks
Change in visceral fat
Tidsramme: 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).
Baseline, 9 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Miami

Efterforskere

  • Ledende efterforsker: Wesley Smith, Ph.D., University of Miami

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. oktober 2019

Primær færdiggørelse (Faktiske)

21. december 2019

Studieafslutning (Faktiske)

21. december 2019

Datoer for studieregistrering

Først indsendt

22. oktober 2019

Først indsendt, der opfyldte QC-kriterier

22. oktober 2019

Først opslået (Faktiske)

24. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20190936

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Overvægt og fedme

Kliniske forsøg med Exercise Protocol

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Indonesia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner