NCT03515642

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2018

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

April 21, 2018

Last Update Submit

March 23, 2020

Conditions

Metabolic Disturbance

Keywords

Gut microbiotaHepatic functionObesityExercise

Outcome Measures

Primary Outcomes (2)

  • Gut microbiota

    Change from Baseline in the gut microbiota composition measured by amplicon sequencing

    Baseline, and 6 weeks immediately after the interventions ends

  • Plasma metabolomic profile

    Change from Baseline in the metabolomic profile will be also evaluated by a HPLC-MS approach

    Baseline, and 6 weeks immediately after the interventions ends

Secondary Outcomes (18)

  • Plasma hepatokines

    Baseline, and 6 weeks immediately after the interventions ends

  • Plasma hepatokines

    Baseline, and 6 weeks immediately after the interventions ends

  • Plasma hepatokines

    Baseline, and 6 weeks immediately after the interventions ends

  • Plasma hepatokines

    Baseline, and 6 weeks immediately after the interventions ends

  • Glucose

    Baseline, and 6 weeks immediately after the interventions ends

  • +13 more secondary outcomes

Study Arms (2)

HIIT group

EXPERIMENTAL

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.

Behavioral: HIIT group

SIT group

ACTIVE COMPARATOR

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).

Behavioral: HIIT group

Interventions

HIIT groupBEHAVIORAL

Physical Training

Also known as: High/low volume exercise
HIIT groupSIT group

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Acute or chronic illness
  • Use of antibiotics the past 2 months
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robinson Ramírez-Vélez

Bogotá, Cundinamarca, 111221, Colombia

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2018

First Posted

May 3, 2018

Study Start

March 25, 2018

Primary Completion

June 1, 2019

Study Completion

August 30, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)