Gut-Brain-axis: Targets for Improvement of Cognition in the Elderly
NCT04841668, Completed, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Gut-Brain-axis: Targets for Improvement of Cognition in the Elderly | ClinicalTrials.gov |
| NCT number | NCT04841668 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 50 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | ClinicalTrials.gov |
| Conditions | Type 2 Diabetes Mellitus | ClinicalTrials.gov |
| Interventions | Metformin | ClinicalTrials.gov |
| First posted | 2021-04-12 | ClinicalTrials.gov |
| Last updated | 2026-03-31 | ClinicalTrials.gov |
Registered outcomes 51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Gut microbiota composition. | 12 months | It will be identified in the stool by cultures and DNA and mRNA expression after metformin treatment. | ClinicalTrials.gov |
| Primary | Cognitive impairment | 12 months | It will be measured by Mini-Examen Cognoscitivo (MEC). | ClinicalTrials.gov |
| Primary | Audioverbal memory | 12 months | It will be measured by Test aprendizaje verbal-TAVEC. | ClinicalTrials.gov |
| Primary | Visual memory | 12 months | It will be measured by Rey-Osterrieth Complex Figure. | ClinicalTrials.gov |
| Primary | Depressive symptomatology | 12 months | It will be measured by Patient Health Questionnaire-9 (PHQ-9). | ClinicalTrials.gov |
| Primary | Impulsivity | 12 months | It will be measured by UPPS Impulsive Behavior Scale. | ClinicalTrials.gov |
| Primary | Food Addiction | 12 months | It will be measured by Yale Food Addiction Scale. | ClinicalTrials.gov |
| Primary | Behavioral inhibition | 12 months | It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). | ClinicalTrials.gov |
| Primary | Behavioral activation | 12 months | It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). | ClinicalTrials.gov |
| Primary | Visoconstructive function | 12 months | It will be measured by Rey-Osterrieth Complex Figure. | ClinicalTrials.gov |
| Primary | Visuospatial perception | 12 months | It will be measured by Judgment Line Orientation. | ClinicalTrials.gov |
| Primary | Naming | 12 months | It will be measured by Boston Naming Test. | ClinicalTrials.gov |
| Primary | Selective and alternating attention | 12 months | It will be measured by Trail making test (Part A y B). | ClinicalTrials.gov |
| Primary | Attention and working memory | 12 months | It will be measured by the Wechsler Adult Intelligence Scales, Fourth Edition (WAIS-IV). | ClinicalTrials.gov |
| Primary | Inhibition | 12 months | It will be measured by Stroop Color-Word Test. | ClinicalTrials.gov |
| Primary | Phonemic verbal fluency | 12 months | It will be measured by PMR | ClinicalTrials.gov |
| Primary | Semantic verbal fluency | 12 months | It will be measured by Animals | ClinicalTrials.gov |
| Secondary | The percentage of time in glucose target range (glucose level 70mg/dl-180mg/dl) | 12 months | ClinicalTrials.gov | |
| Secondary | Effect on gut microbiota | 12 months | Gut microbiota will be analysed by metagenomics and metabolomics. | ClinicalTrials.gov |
| Secondary | The percentage of time in glucose range (glucose level below 100 mg/dl) | 12 months | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 51
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 8013758 | BACKGROUND | PubMed |
| 8532986 | BACKGROUND | PubMed |
| 10718348 | BACKGROUND | PubMed |
| 11118008 | BACKGROUND | PubMed |
| 11602624 | BACKGROUND | PubMed |
| 12086935 | BACKGROUND | PubMed |
| 12930161 | BACKGROUND | PubMed |
| 16219009 | BACKGROUND | PubMed |
| 16360788 | BACKGROUND | PubMed |
| 16443885 | BACKGROUND | PubMed |
| 17183300 | BACKGROUND | PubMed |
| 17350699 | BACKGROUND | PubMed |
| 17977953 | BACKGROUND | PubMed |
| 18089955 | BACKGROUND | PubMed |
| 18220635 | BACKGROUND | PubMed |
| 18347351 | BACKGROUND | PubMed |
| 18382744 | BACKGROUND | PubMed |
| 18806222 | BACKGROUND | PubMed |
| 18806780 | BACKGROUND | PubMed |
| 20415290 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Picture Naming Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)