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CompletedNCT02915913BrainFitUpdated Oct 11, 2018

Effects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults

An interventional study of Experimental: High Intensity Interval and Resistance training in Cognitive Function, Motor Activity and Obesity, sponsored by Universidad Santo Tomas. Completed at 1 site in Colombia. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-11.

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

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
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Study summary

The BrainFit Study aims to examine acute effects of High Intensity Interval- vs Resistance or Combined program has benefits on Cognitive Function as well as on secretion and regulation of neurotrophic factors or neurotrophins in a cohort of sedentary, overweight adults (aged 18-30 years) from Bogota, Colombia.

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Conditions studied

  • Cognitive Function
  • Motor Activity
  • Obesity

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03

In context

Overweight

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

This study's enrollment of 60 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

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.

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Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Written informed consent.
  • Interested in improving health and fitness.
  • Central obesity: waist circumference ≥90cm
  • Body mass index ≥ 26 kg/m(2)

Exclusion criteria

Exclusion Criteria:

  • Systemic infections.
  • Weight loss or gain of >10% of body weight in the past 6 months for any reason.
  • Currently taking medication that suppresses or stimulates appetite.
  • Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
  • Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
  • Asthma.
  • Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.
  • Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
  • Any active use of illegal or illicit drugs.
  • Current exerciser (>30 min organized exercise per week).
  • Indication of unsuitability of current health for exercise protocol (PARQ).
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    High Intensity Interval

    One session for 30-60 minutes of high intensity aerobic exercise

    Behavioral: Experimental: High Intensity Interval

  • Experimental
    Resistance training

    One session for 30-60 minutes of resistance exercise

    Behavioral: Resistance training

  • Experimental
    Plus: High Intensity Interval + Resistance Training

    One session for 30-60 minutes of high intensity aerobic exercise and resistance exercise

    Behavioral: Plus: High Intensity Interval + Resistance Training

  • Placebo comparator
    Non-exercise

    Non-exercise

    Other: Non-exercise

Interventions

  • BehavioralExperimental: High Intensity Interval

    Walking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 500 kcal

  • BehavioralResistance training

    Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 500 kcal

  • BehavioralPlus: High Intensity Interval + Resistance Training

    Walking on a treadmill as intervention 1 until 50% the energy expenditure prescribed is reached, then completing a resistance circuit until 100% energy expenditure is reached

  • OtherNon-exercise

    This group will receive the usual clinical care according to the consensus recommendations of the national goals for cardiovascular health promotion and disease reduction of the American Heart Association and Colombian guidelines COLDEPORTES.

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What researchers measure

Primary outcomes

  1. Change from Baseline in Brain-derived neurotrophic factor

    Measurement of serum Brain-derived neurotropic factor true blood samples.

    Time frame: Baseline and 60 minutes immediately after the interventions ends

Secondary outcomes

  1. Change from Baseline in Neurotrophin-3

    Time frame: Baseline and 60 minutes immediately after the interventions ends

  2. Change from Baseline in Neurotrophin-4

    Time frame: Baseline and 60 minutes immediately after the interventions ends

  3. Change from Baseline change in Cognitive Function

    Cognitive Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.

    Time frame: Baseline and 60 minutes immediately after the interventions ends

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Study locations

1 site
  • Robinson Ramírez-Vélez
    Bogota, Cundinamarca 000000000, Colombia
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References and documents

Publications

  • Dominguez-Sanchez MA, Bustos-Cruz RH, Velasco-Orjuela GP, Quintero AP, Tordecilla-Sanders A, Correa-Bautista JE, Triana-Reina HR, Garcia-Hermoso A, Gonzalez-Ruiz K, Pena-Guzman CA, Hernandez E, Pena-Ibagon JC, Tellez-T LA, Izquierdo M, Ramirez-Velez R. Acute Effects of High Intensity, Resistance, or Combined Protocol on the Increase of Level of Neurotrophic Factors in Physically Inactive Overweight Adults: The BrainFit Study. Front Physiol. 2018 Jun 27;9:741. doi: 10.3389/fphys.2018.00741. eCollection 2018. PubMed 29997519 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02915913
Lead sponsor
Universidad Santo Tomas
Collaborators
Universidad del Rosario, Universidad Nacional de Colombia
Responsible party
Sponsor
First posted
Sep 27, 2016
Start date
Sep 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Oct 11, 2018

Study contacts

Robinson Ramírez-Vélez, Ph.D
study director · Universidad del Rosario

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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