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Metabolic DisturbanceNCT03515642

Exercise, Gut Microbiota in Sedentary Adults With Overweight

A study testing HIIT group in people with Metabolic Disturbance, run by Universidad Santo Tomas at 1 site in Colombia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Metabolic Disturbance
What is being tested?
HIIT group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteColombia
Study dates
25 Mar 2018to 30 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Robinson Ramírez-Vélez

    Bogotá, Cundinamarca, 111221

Other trials in Colombia

About this study

Official title: Effect of Two Exercise Programme on Gut Microbiota, Hepatic Metabolism and Adipokines in Sedentary Adults With Overweight

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.

Being tested
HIIT group
Keywords
Gut microbiota, Hepatic function, Obesity, Exercise
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIIT groupBehavioural

    Also called High/low volume exercise

    Physical Training

Study groups in NCT03515642
Study groupRoleWhat they receive
HIIT groupExperimentalThe 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.
Receives: Behavioral: HIIT group
SIT groupActive comparatorThe 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).
Receives: Behavioral: HIIT group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gut microbiota

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

    Measured: 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

    Measured: Baseline, and 6 weeks immediately after the interventions ends

Secondary outcomes (18)

  1. Plasma hepatokines

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Baseline, and 6 weeks immediately after the interventions ends

  5. Glucose

    Change from Baseline will be also evaluated by a spectroscopy

    Measured: Baseline, and 6 weeks immediately after the interventions ends

  6. Insulin

    Change from Baseline will be also evaluated by a ELISA

    Measured: Baseline, and 6 weeks immediately after the interventions ends

  7. Glycated hemoglobin

    Change from Baseline will be also evaluated by a ELISA

    Measured: Baseline, and 6 weeks immediately after the interventions ends

  8. Bioinflammatory blood markers

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

    Measured: Baseline, and 6 weeks immediately after the interventions ends

  9. Bioinflammatory blood markers

    Change from Baseline measure of plasma IL6 concentrations measured ELISA

    Measured: Baseline, and 6 weeks immediately after the interventions ends

  10. Bioinflammatory blood markers

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

    Measured: Baseline, and 6 weeks immediately after the interventions ends

  11. Bioinflammatory blood markers

    Change from Baseline measure of plasma CRP concentrations measured ELISA

    Measured: Baseline, and 6 weeks immediately after the interventions ends

  12. Body composition

    Differences in body weight (kilograms) measured by DXA

    Measured: Baseline, and 6 weeks immediately after the interventions ends

  13. Body composition

    Differences in body fat (%) measured by DXA

    Measured: Baseline, and 6 weeks immediately after the interventions ends

  14. Body composition

    Differences in mass muscle measured by DXA

    Measured: Baseline, and 6 weeks immediately after the interventions ends

  15. Physical fitness

    Differences in Muscular strength (handgrip test) in kg

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: Baseline, and 6 weeks immediately after the interventions ends

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2018
  2. Study start25 Mar 2018
  3. Primary completion1 Jun 2019 (estimated)
  4. Study completion30 Aug 2019 (estimated)

Why it stopped: Study halted prematurely, prior to enrollment of first participant due to PI not employment at University.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03515642
Sponsor's protocol ID
DVO005-1-338-CEI882
Status last verified
Mar 2020
First submitted
21 Apr 2018
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing HIIT group in people with Metabolic Disturbance, run by Universidad Santo Tomas at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gut microbiota (time frame: Baseline, and 6 weeks immediately after the interventions ends). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03515642.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

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