Exercise, Gut Microbiota in Sedentary Adults With Overweight

NCT ID: NCT03515642

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-25

Study Completion Date

2019-08-30

Brief Summary

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This project offers the opportunity to obtain detailed measurements on the health of body composition, metabolic health, and intestinal microbial diversity in overweight adults; moreover to provide information about the effects of physical exercise on them. The aim of the research is to advance in the understanding of the mechanisms induced by physical exercise, which includes the measurement of nutritional parameters, clinical and biochemical biomarkers of hepatic/cardiometabolic health, as well as the application of differential proteomics technologies by means of Arrays of cytokines and intestinal microbiome, making this study a novel and pioneer in sensitive areas of primary health care in Latin America.

Detailed Description

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Conditions

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Metabolic Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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HIIT group

The HIIT modality consisted of 30-40 minutes (min) of steady-state, high-intensity training 3 d/wk on a stationary bicycle at the target heart rate (HR) range equivalent to 85% to 95% of the individual's maximum oxygen consumption rate (VO2max). Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 6-weeks.

Group Type EXPERIMENTAL

HIIT group

Intervention Type BEHAVIORAL

Physical Training

SIT group

The SIT modality consisted of 6 to 10 repetitions of a 30 s segment of all-out exercise interspersed with 2 min of recovery, 3 d/wk on a stationary bicycle at the target heart rate (HR) range equivalent to 90% to 95% of the individual's maximum oxygen consumption rate (VO2max).

Group Type ACTIVE_COMPARATOR

HIIT group

Intervention Type BEHAVIORAL

Physical Training

Interventions

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HIIT group

Physical Training

Intervention Type BEHAVIORAL

Other Intervention Names

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High/low volume exercise

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Sedentary males
* BMI\>25 kg/m2, on a stable body weight for the last 3 months

Exclusion Criteria

* Acute or chronic illness
* Use of antibiotics the past 2 months
* Smoking
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Santiago de Chile

OTHER

Sponsor Role collaborator

Universidad Pública de Navarra

OTHER

Sponsor Role collaborator

Universidad del Rosario

OTHER

Sponsor Role collaborator

NavarraBiomed Biomedical Research Center

OTHER

Sponsor Role collaborator

Universidad Santo Tomas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Robinson Ramírez-Vélez

Bogotá, Cundinamarca, Colombia

Site Status

Countries

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Colombia

Other Identifiers

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DVO005-1-338-CEI882

Identifier Type: -

Identifier Source: org_study_id

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