Exercise and Nutrition on Obese Microbiome
3 januari 2020 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
31
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Florida
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Miami, Florida, Verenigde Staten, 33146
- University of Miami
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in fecal microbiota diversity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Wesley Smith, Ph.D., University of Miami
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
21 oktober 2019
Primaire voltooiing (Werkelijk)
21 december 2019
Studie voltooiing (Werkelijk)
21 december 2019
Studieregistratiedata
Eerst ingediend
22 oktober 2019
Eerst ingediend dat voldeed aan de QC-criteria
22 oktober 2019
Eerst geplaatst (Werkelijk)
24 oktober 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
7 januari 2020
Laatste update ingediend die voldeed aan QC-criteria
3 januari 2020
Laatst geverifieerd
1 januari 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20190936
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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