Trial · NCT03943979
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in food intake | 4 consecutive days during the week before starting the treatment; 4 consecutive days during the week of treatment; | Changes in food consumption (medium kcal intake ) from baseline to the end of the treatment measured by 4-day food registers during the week before starting the treatment and during the 4 days of treatment. The dietary records were checked by a nutritionist and analyzed through the software PCN Pro 1.0. |
| Primary | Stability of changes in food intake | 4 consecutive days during the week before starting the treatment and 4 consecutive days during the week after finishing the treatment | Changes in food consumption (medium kcal intake ) from baseline to the follow-up assessment measured by 4-day food registers during the week before starting the treatment and the week after finishing the treatment. The dietary records were checked by a nutritionist and analyzed through the software PCN Pro 1.0. |
| Secondary | Change in electroencephalogram (EEG) power and coherence | Every training session (4 consecutive days), 3 minutes before starting the training session and 3 minutes after finishing the training. | EEG was recorded before and after tCS/sham using a Starstim device (Neuroelectrics), same electrode positions as for the stimulation with a sampling frequency of 500 S/s . Electrode impedance: below 10kΩ; electrical reference placed at the right earlobe. EEG data was analyzed offline by means of customized Matlab code (MathWorks Inc. Natick, MA, USA). Data was split into 1s non-overlapping epochs (epochs with amplitudes \>50 μV were rejected). EEG-metrics extracted: EEG-power and coherence. To compute EEG power, the power spectral density (PSD) was estimated for each epoch. Band Power was computed for the bands θ=\[4,8 Hz\], α=\[8,13 Hz\] β=\[13,25 Hz\], γ=\[30, 45 Hz\] and broadband=\[4-45Hz\] by integrating the PSD within the band frequency limits. Functional connectivity was estimated by means of coherence by the Welch method averaged over all electrodes. Frontal asymmetry (FA) computed as follows: log(avg(AF4 F4 F8 FC6))-log(avg(AF3 F3 F7 FC5); FA\<0 reflects dominance of left-hemisphere |
| Secondary | Change in Body Mass Index (BMI) | One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment) | Change in BMI. BMI calculation: body weight divided by the square of the body height (expressed in units of kg/m2). Weight and height measures were taken by a nurse. |
| Secondary | Change in endocannabinoids (and related compounds) plasmatic concentrations. | One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment) | Change in endocannabinoids and related compounds (acylglycerols and fatty acid N-acylethanolamides) as measured in plasmatic concentrations and quantified by LC/MS-MS by a previously validated method (Pastor et al. 2014). |
| Secondary | Change in hormonal measurements : Leptin and adiponectin plasmatic/serum concentrations | One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment) | Measurement of change in hormones regulating the appetite and energic homeostasis of secretion in fatty tissues. |
| Secondary | Change in neuropsychological test: Intra-extra dimension (IED-CANTAB Cambridge Cognition) | One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment) | Executive functions: flexibility |
| Secondary | Change in neuropsychological test: Stroop Colours and Words test (SCWT, Golden C.J., 1978; Stroop, 1935) | One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment) | Executive functions: inhibition |
| Secondary | Change in neuropsychological test: Iowa Gambling Task (IGT, Bechara et al., 1994, 2002) | One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment) | Executive functions: decision-making, risky behaviour. |
| Secondary | Change in neuropsychological test: Spatial Span (SSP; CANTAB Cambridge Cognition) | One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment) | Executive functions: working memory |
| Secondary | Change in neuropsychological test: Stockings of Cambridge (SOC; CANTAB Cambridge Cognition) | One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment) | Executive functions: planning |
| Secondary | Change in neuropsychological test: Conners Continuous Performance Test (CPT, Conners & MHS Staff, 2000) | One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment) | Executive functions: Attention |
| Secondary | Change in neuropsychological test: Simple Reaction Time (SRT; CANTAB Cambridge Cognition) | One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment) | Executive functions: Attention |
| Secondary | Change in neuropsychological test:Symbol digit modalities test (SDMT; Smith A. 1982). | One day during the week before starting the training (pre-treatment) and the 1 day after finishing the treatment (post-treatment) | Executive functions: Attention and Processing speed |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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