Obesity Clinical Trial
— BrainFitOfficial title:
Effects of High Intensity Interval- vs Resistance or Combined- Training for Improving Cognitive Function and Neurotrophic Factors in Overweight Adults (BrainFit Study): Factorial Randomised Controlled Trial
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 |
Verified date | October 2018 |
Source | Universidad Santo Tomas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Colombia | Robinson Ramírez-Vélez | Bogota | Cundinamarca |
Lead Sponsor | Collaborator |
---|---|
Universidad Santo Tomas | Universidad del Rosario, Universidad Nacional de Colombia |
Colombia,
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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