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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02915913
Other study ID # 2016-09-22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date December 2016

Study information

Verified date October 2018
Source Universidad Santo Tomas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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:

- 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).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Experimental: 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
Resistance 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
Plus: 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
Other:
Non-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.

Locations

Country Name City State
Colombia Robinson Ramírez-Vélez Bogota Cundinamarca

Sponsors (3)

Lead Sponsor Collaborator
Universidad Santo Tomas Universidad del Rosario, Universidad Nacional de Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Brain-derived neurotrophic factor Measurement of serum Brain-derived neurotropic factor true blood samples. Baseline and 60 minutes immediately after the interventions ends
Secondary Change from Baseline in Neurotrophin-3 Baseline and 60 minutes immediately after the interventions ends
Secondary Change from Baseline in Neurotrophin-4 Baseline and 60 minutes immediately after the interventions ends
Secondary Change from Baseline change in Cognitive Function Cognitive Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc. Baseline and 60 minutes immediately after the interventions ends
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