Exercise and Nutrition on Obese Microbiome
3 janvier 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
31
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Florida
-
Miami, Florida, États-Unis, 33146
- University of Miami
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Expérimental: Exercise with CR-LC Group
Participants will receive the exercise protocol and CR-LC Diet regimen.
|
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).
|
|
Expérimental: Exercise with Ancestral Diet (AD) Group
Participants will receive the exercise protocol and AD regimen.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in fecal microbiota diversity
Délai: Baseline, 9 weeks
|
Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation
|
Baseline, 9 weeks
|
|
Change in Bacteriodetes/Firmicutes ratio
Délai: Baseline, 9 weeks
|
Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation
|
Baseline, 9 weeks
|
|
Percent change in fecal microbiota composition
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline, 9 weeks
|
The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.
|
Baseline, 9 weeks
|
|
Change in body weight
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline, 9 weeks
|
Change in waist circumference measured in inches.
|
Baseline, 9 weeks
|
|
Change in blood pressure
Délai: Baseline, 9 weeks
|
Change in blood pressure assessed as systolic and diastolic pressure in mmHg.
|
Baseline, 9 weeks
|
|
Change in visceral fat
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Wesley Smith, Ph.D., University of Miami
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
21 octobre 2019
Achèvement primaire (Réel)
21 décembre 2019
Achèvement de l'étude (Réel)
21 décembre 2019
Dates d'inscription aux études
Première soumission
22 octobre 2019
Première soumission répondant aux critères de contrôle qualité
22 octobre 2019
Première publication (Réel)
24 octobre 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20190936
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .