Effect of Nordic Berries on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiota in Adults With Mild Cognitive Impairment
NCT04317612, Not applicable, Completed, Region Skane
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of Nordic Berries on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiota in Adults With Mild Cognitive Impairment | ClinicalTrials.gov |
| NCT number | NCT04317612 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 96 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Region Skane | ClinicalTrials.gov |
| Conditions | Cognitive Impairment, Mild, Memory Impairment | ClinicalTrials.gov |
| Interventions | Active berry product, Reference product | ClinicalTrials.gov |
| First posted | 2020-03-23 | ClinicalTrials.gov |
| Last updated | 2024-03-01 | ClinicalTrials.gov |
Registered outcomes 43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | CANTAB - Paired Associate Learning test (PAL28) | 12 weeks | To investigate how daily berry intake affects cognitive function (primary objective) measured by episodic memory | ClinicalTrials.gov |
| Secondary | Episodic memory (test verbal recognition memory (VRM) (free-, immediate- and delayed recall) | 12 weeks | ClinicalTrials.gov | |
| Secondary | Attention, psychomotor speed and executive function (Trail making test (TMT) A and B) | 12 weeks | ClinicalTrials.gov | |
| Secondary | Selective attention and processing speed (Stroop color-word test) | 12 weeks | ClinicalTrials.gov | |
| Secondary | Verbal fluency (letter "S" word fluency test) | 12 weeks | Number of novel words on letter "S" during 60 seconds. | ClinicalTrials.gov |
| Secondary | Behavior and quality of life (AES, Apathy evaluation score (self)) | 12 weeks | Answers given by the participants on 18 questions reflect apathy including behavioral, cognitive and emotional indicators on a scale 18-72 where higher scores reflect more apathy. | ClinicalTrials.gov |
| Secondary | Behavior and quality of life (Apathy evaluation score (informant)) | 12 weeks | Answers given by someone close to the participant on 18 questions reflect apathy including behavioral, cognitive and emotional indicators on a scale 18-72 where higher scores reflect more apathy. | ClinicalTrials.gov |
| Secondary | EuroQol five dimension (EQ-5D) life quality score. | 12 weeks | Participant marks on a visual analogue scale from 0 to 100 how they value their current health status where 0 represents the lowest, and 100 highest, health status and quality of life. | ClinicalTrials.gov |
| Secondary | Hospital Anxiety Depression (HAD) Score. | 12 weeks | Self-assessment with 14 items that assess anxiety and depression symptoms before and after the intervention on a scale from 0 to 21, with higher scores indication the presence of symptoms. | ClinicalTrials.gov |
| Secondary | Systolic blood pressure | 12 weeks | Change in systolic blood pressure in mm/Hg | ClinicalTrials.gov |
| Secondary | Diastolic blood pressure | 12 weeks | Change in diastolic blood pressure in mm/Hg | ClinicalTrials.gov |
| Secondary | Heart rate | 12 weeks | Change in bpm (beats per minute) | ClinicalTrials.gov |
| Secondary | Body weight | 12 weeks | Change in body weight (kg) | ClinicalTrials.gov |
| Secondary | BMI | 12 weeks | Change in body weight index (kg/m\^2) | ClinicalTrials.gov |
| Secondary | Body fat composition | 12 weeks | Body fat composition (% body fat, fat free mass (kg), basal metabolic rate (BMR) measured with TANITA scale. | ClinicalTrials.gov |
| Secondary | Waist-to-hip ratio | 12 weeks | Waist circumference/hip circumference | ClinicalTrials.gov |
| Secondary | Fasting glucose (mM) | 12 weeks | ClinicalTrials.gov | |
| Secondary | Fasting insulin | 12 weeks | ClinicalTrials.gov | |
| Secondary | HOMA-IR | 12 weeks | Homeostasis model assessment of insulin resistance (HOMA-IR) | ClinicalTrials.gov |
| Secondary | Lipid metabolism: total cholesterol mg/dl | 12 weeks | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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 |
|---|---|---|
| Paired Associate Learning | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary 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)