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WithdrawnNCT03515642Updated Mar 25, 2020

Exercise, Gut Microbiota in Sedentary Adults With Overweight

An interventional study of HIIT group in Metabolic Disturbance, sponsored by Universidad Santo Tomas. Withdrawn at 1 site in Colombia. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-25.

Sponsored by Universidad Santo Tomas · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Study halted prematurely, prior to enrollment of first participant due to PI not employment at University.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Metabolic Disturbance

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Keywords

  • Gut microbiota
  • Hepatic function
  • Obesity
  • Exercise
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

Browse Overweight studies →

Lead sponsor

Universidad Santo Tomas is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Acute or chronic illness
  • Use of antibiotics the past 2 months
  • Smoking
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: HIIT group

  • Active comparator
    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).

    Behavioral: HIIT group

Interventions

  • BehavioralHIIT group

    Physical Training

    Also known as: High/low volume exercise

06

What researchers measure

Primary outcomes

  1. Gut microbiota

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

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  2. Plasma metabolomic profile

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

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

Secondary outcomes

  1. Plasma hepatokines

    Change from Baseline in the Chemerin will be measured using ELISA kits

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  2. Plasma hepatokines

    Change from Baseline in the Selenoprotein P will be measured using ELISA kits

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  3. Plasma hepatokines

    Change from Baseline in the Fetuin-A will be measured using ELISA kits

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  4. Plasma hepatokines

    Change from Baseline in the FGF21 (fibroblast growth factor 21) Leukocyte cell-derived will be measured using ELISA kits

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  5. Glucose

    Change from Baseline will be also evaluated by a spectroscopy

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  6. Insulin

    Change from Baseline will be also evaluated by a ELISA

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  7. Glycated hemoglobin

    Change from Baseline will be also evaluated by a ELISA

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  8. Bioinflammatory blood markers

    Change from Baseline measure of plasma IL-1 concentrations measured ELISA

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  9. Bioinflammatory blood markers

    Change from Baseline measure of plasma IL6 concentrations measured ELISA

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  10. Bioinflammatory blood markers

    Change from Baseline measure of plasma TNF-alfa concentrations measured ELISA

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  11. Bioinflammatory blood markers

    Change from Baseline measure of plasma CRP concentrations measured ELISA

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  12. Body composition

    Differences in body weight (kilograms) measured by DXA

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  13. Body composition

    Differences in body fat (%) measured by DXA

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  14. Body composition

    Differences in mass muscle measured by DXA

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  15. Physical fitness

    Differences in Muscular strength (handgrip test) in kg

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  16. Physical fitness

    Differences in Maximum Oxygen Consumption (VO2 max K5 Gas Analyser) in ml/kg/min

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  17. Energy substrate oxidation

    Fat and carbohydrate oxidation in the fasted and postprandial state measured before and after the interventions using indirect calorimetry (K5 cosmed)

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

  18. Resting Metabolic Rate

    Resting metabolic rate was measured before and after the interventions (K5 Cosmed)

    Time frame: Baseline, and 6 weeks immediately after the interventions ends

07

Study locations

1 site
  • Robinson Ramírez-Vélez
    Bogotá, Cundinamarca 111221, Colombia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03515642
Lead sponsor
Universidad Santo Tomas
Collaborators
Universidad de Santiago de Chile, Universidad Pública de Navarra, Universidad del Rosario, NavarraBiomed Biomedical Research Center
Responsible party
Sponsor
First posted
May 3, 2018
Start date
Mar 25, 2018
Primary completion
Jun 1, 2019 (estimated)
Completion
Aug 30, 2019 (estimated)
Last update
Mar 25, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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