BrainFit-Nutrition: Intervention study for people with mild cognitive impairment using computerised cognitive training tools and a nutrition intervention
| ISRCTN | ISRCTN10560738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10560738 |
| Secondary identifying numbers | 21-318_1-B |
- Submission date
- 19/10/2021
- Registration date
- 23/11/2021
- Last edited
- 27/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
With increasing life expectancy, the number of older people suffering from cognitive impairments increases. Mild cognitive impairment (MCI) often results in dementia (about 15% of people with MCI will eventually have dementia). Currently, there is no drug treatment for the primary prevention of dementia.
Studies show that cognitive training can improve the cognitive abilities of people with MCI. Computerized cognitive training (CCT) offers several advantages over traditional paper-and-pencil cognitive training and has the potential to be more individualized by matching task difficulty with individual performance. Recent reviews have reported promising effects of CCT on improving the cognitive capacities of people with MCI.
Several studies have indicated positive effects of predominantly whole food, plant-based diets on cognitive functions. A current analysis of a study of the German Center for Neurodegenerative Diseases confirmed a Mediterranean diet as protective against cognitive impairment and dementia. In addition, plant-based diets have been shown to be successful in the treatment of chronic diseases associated with a higher prevalence of dementia.
This study investigates the effects of CCT and nutrition on cognition. There are two CCT groups: an ‘individualized’ CCT (iCCT) specialized for people with MCI that automatically matches task difficulty with individual performance, and a ‘basic’ CCT (bCCT). There are two nutrition intervention groups: an anti-inflammatory, neuroprotective, whole-food, plant-based diet and a diet recommended by the DGE (German Nutrition Society). The primary aim is to prove that the MCI-specialized CCT combined with a whole-food, plant-based diet will lead to better results in cognitive abilities than the other conditions. The secondary aims are to prove that a) compared with the basic CCT the MCI-specialized CCT will lead to better cognitive abilities and b) compared to the DGE-recommended diet the whole food, plant-based diet, will lead to better cognitive abilities.
Who can participate?
Community-dwelling people aged 60 years and above with MCI
What does the study involve?
This study compares two CCTs, MCI-specialized CCT and basic CCT, and two nutrition interventions, a whole-food, plant-based diet and a diet recommended by the DGE (German Nutrition Society). Participants are randomly allocated to one of these four groups. Both CCTs can be used from home with a computer, laptop or tablet. Participants can use the digital intervention as often as they wish over the duration of the study (6 months). Both nutritional intervention groups receive ongoing online group counselling every 14 days over the duration of the study, either on a whole-food, plant-based diet or according to the recommendations of the DGE, respectively.
What are the possible benefits and risks of participating?
The CCT might have an impact on existing excessive computer use. However, the cognitive training is not oriented on motivational or emotional components. The digital training requires cognitive performance which will lead to exhaustion. The negative effects of nutrition interventions are rare and relatively small. The following unwanted effects can occur: a feeling of heat, different mouth and/or body odour, constipation, diarrhea, flatulence, stomach cramps, nausea and vomiting
With the CCT, the researchers expect to stabilize cognitive performance. In the long run, it is expected that it will help older adults with MCI to remain independent. Also, it may delay the shift from MCI to dementia. Additionally, the researchers expect positive effects on other non-cognitive aspects and quality of life. Participants of both of the nutrition intervention groups receive a potentially effective and equivalent intervention. Therefore, there is a predictable possible benefit of participating in the study.
Where is the study run from?
1. Center for Health Services Research, University Hospital Erlangen (Germany)
2. Complementary and Integrative Medicine Group of the Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin (Germany)
When is the study starting and how long is it expected to run for?
June 2021 to May 2024
Who is funding the study?
Karl und Veronica Carstens‐Stiftung (Germany)
Who is the main contact?
1. Prof. Elmar Graessel
elmar.graessel@uk-erlangen.de
2. PD Dr. Christian Kessler
christian.kessler@charite.de
Contact information
Scientific
Center for Health Services Research
Schwabachanlage 10
Erlangen
91054
Germany
| Phone | +49 (0)91318534142 |
|---|---|
| elmar.graessel@uk-erlangen.de |
Scientific
Charité - Universitätsmedizin Berlin
Institute of Social Medicine, Epidemiology and Health Economics
Complementary and Integrative Medicine Group
Königstraße 63
Berlin
14109
Germany
| Phone | +49 (0)3080505617 |
|---|---|
| christian.kessler@charite.de |
Study information
| Study design | Prospective double-blind randomized controlled intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | 40565_PIS.pdf |
| Scientific title | Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: Study protocol of a completely digital, randomised, controlled trial |
| Study acronym | BrainFit-Nutrition |
| Study objectives | Current hypothesis as of 29/12/2021: Primary hypothesis I: Individualised CCT will lead to statistically significantly greater improvements in cognitive capacities during the intervention period of six months compared with basic CCT. Primary hypothesis II: Online nutritional group counselling focusing on a WFPB diet will lead to statistically significantly greater improvements in cognitive capacities during the intervention period of 6 months compared with online nutritional group counselling focusing on a healthy diet recommended by the German Nutrition Society. Secondary hypothesis: Individualised CCT in combination with online nutritional group counselling focusing on a WFPB diet will have a positive interaction effect. The group with iCCT in combination with online nutritional group counselling focusing on a WFPB diet will show more cognitive improvements than all other groups during the intervention period of six months in people with MCI. _____ Previous hypothesis: Primary hypothesis: Individualized computerized cognitive training (CCT) and a whole-food, plant-based diet have a positive interaction effect. The group with individualized CCT and a plant-based diet show more cognitive improvements than all other groups. Secondary hypothesis: Individualized CCT will lead to statistically significantly greater improvements in cognitive capacities during the intervention period of 6 months in people with mild cognitive impairment (MCI) as compared with basic CCT. Tertiary hypothesis: A whole-food, plant-based diet will lead to statistically significantly greater improvements in cognitive capacities during the intervention period of 6 months in people with MCI as compared to the DGE (German Nutrition Society)-recommended diet. |
| Ethics approval(s) | Approved 21/09/2021, Friedrich-Alexander-University Erlangen-Nürnberg Ethics Committee (Krankenhausstraße 12, 91054 Erlangen; +49 (0)9131 85-22270; ethikkommission@fau.de), ref: 21-318_1-B |
| Health condition(s) or problem(s) studied | Mild cognitive impairment (MCI) |
| Intervention | An external department will create randomization lists (Institute of Medical Informatics, Biometry, and Epidemiology, Friedrich-Alexander University Erlangen-Nürnberg, Waldstraße 6, 91054 Erlangen). Participants are randomly allocated into one of four groups with two intervention variables (BrainFit and Nutrition): 1. BrainFit: two versions of computerized cognitive training: individualized (iCCT), which involves targeted exercises for memory span, information processing, visual-spatial cognition, etc, and basic (bCCT), which involves basic exercises for memory span, information processing, visual-spatial cognition, etc 2. Nutrition: two types of nutritional intervention: an anti-inflammatory, neuroprotective, whole-food, plant-based diet and a diet recommended by the DGE (German Nutrition Society) Both CCTs (iCCT and bCCT) can be used from home with a computer, laptop or tablet. Participants can use the digital intervention as often as they wish over the duration of the trial (6 months). Both nutritional intervention groups receive ongoing online group counselling every 14 days over the duration of the trial, either on a whole-food, plant-based diet or according to the recommendations of the DGE, respectively. |
| Intervention type | Mixed |
| Primary outcome measure | Current primary outcome measure as of 26/01/2024: 1. Cognition measured by the Montreal Cognitive Assessment (MoCA) at baseline and after 6 and 12 months Previous primary outcome measures from 06/12/2021 to 26/01/2024: 1. Cognition measured by the Montreal Cognitive Assessment (MoCA) at baseline and after 6 months 2. Cognition measured by the computerised cognitive test battery (ccTB) integrated in the digital software at baseline and after 6 and 12 months Original primary outcome measure: Cognition measured by the Montreal Cognitive Assessment (MoCA) at baseline and after 6 months |
| Secondary outcome measures | Current secondary outcome measures as of 26/01/2024: 1. Cognitive function measured by the Mini-Mental State Examination (MMSE) at baseline and after 6 and 12 months 2. Cognition measured by reaction time and logical thinking assessments delivered and collected by the digital software (cctb) at baseline and after 1, 2, 3, 4, 5 and 6 months 3. Depression measured by the Patient Health Questionnaire 9 (PHQ-9) at baseline and after 6 and 12 months 4. Activities of daily living measured by the Bayer Activities of Daily Living Scale (B-ADL) at baseline and after 6 and 12 months Previous secondary outcome measures from 06/12/2021 to 26/01/2024: 1. Cognitive function measured by the Mini-Mental State Examination (MMSE) at baseline and after 6 and 12 months 2. Depression measured by the Patient Health Questionnaire 9 (PHQ-9) at baseline and after 6 and 12 months 3. Activities of daily living measured by the Bayer Activities of Daily Living Scale (B-ADL) at baseline and after 6 and 12 months Previous secondary outcome measures from 24/11/2021 to 06/12/2021: 1. Cognition measured by the Mini-Mental Status Examination (MMSE) at baseline and after 6 and 12 months 2. Cognition measured by reaction time and logical thinking assessments delivered and collected by the digital software at baseline and after 1, 2, 3, 4, 5 and 6 months Original secondary outcome measures: Cognition measured by the Mini-Mental Status Examination (MMSE) at baseline and after 6 and 12 months to detect the conversion rate to dementia |
| Overall study start date | 01/06/2021 |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 271 |
| Key inclusion criteria | Current inclusion criteria as of 24/11/2021: 1. Mild cognitive impairment: 1.1. Montreal Cognitive Assessment score ≤24 1.2. Mini Mental State Examination score ≥24 2. The digital applications and examinations require a PC with a microphone and camera (Windows/Linux/MacOS), laptop or an Android tablet and basic skills in their use and access to the internet 3. Age ≥60 years 4. Informed consent given Previous inclusion criteria: 1. Mild cognitive impairment: 1.1. Montreal Cognitive Assessment score ≤24 1.2. Mini Mental State Examination score ≥24 2. No depression (Patient Health Questionnaire [PHQ]-9 <12) 3. The digital applications and examinations require a PC with a microphone and camera (Windows/Linux/MacOS), laptop or an Android tablet and basic skills in their use 4. Age ≥60 years 5. Informed consent given 6. Subjective impairment of short-term memory |
| Key exclusion criteria | 1. Completely blind or deaf 2. No personal computer, laptop or tablet 3. Normal cognition, Montreal Cognitive Assessment score >24 4. Dementia, Mini Mental Status Examination score <24 5. Depression, Patient Health Questionnaire 9 score ≥12 6. Diagnosis of another disease that causes cognitive impairment: 6.1. Psychosis (schizophrenia, mania, bipolar psychosis) 6.2. Parkinson's disease 6.3. Multiple sclerosis 6.4. Multiple strokes 6.5. Alcohol abuse/drug consumption (addiction) 6.6. Severe brain disease (tumor, injury, hydrocephalus) 6.7. Severe vitamin B deficiency |
| Date of first enrolment | 03/01/2022 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- Germany
Study participating centres
Center for Health Services Research in Medicine
Friedrich-Alexander-University Erlangen-Nürnberg
Schwabachanlage 10
Erlangen
91054
Germany
Complementary and Integrative Medicine Group
Königstraße 63
Berlin
14109
Germany
Sponsor information
Charity
Am Deimelsberg 36
Essen
45276
Germany
| Phone | +49 (0)201 56305 50 |
|---|---|
| info@carstens-stiftung.de | |
| Website | https://www.carstens-stiftung.de/ |
"ROR" |
https://ror.org/00w6s5b11 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Carstens-Stiftung
- Location
- Germany
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The researchers plan to submit the study protocol to a journal by the end of 2021. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are not expected to be made available because the researchers assure in the participant information sheet that data will not be passed to any third party. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 25/10/2021 | No | Yes | ||
| Participant information sheet | in German version 2 |
17/11/2021 | 23/11/2021 | No | Yes |
| Protocol article | 01/07/2022 | 04/07/2022 | Yes | No | |
| Results article | 24/05/2025 | 27/05/2025 | Yes | No |
Additional files
- 40565_PIS.pdf
- 40565_PIS_v2_17Nov2021.pdf
- in German
Editorial Notes
27/05/2025: Publication reference added.
04/12/2024: The intention to publish date was changed from 31/12/2024 to 31/12/2025.
15/05/2024: The intention to publish date was changed from 30/06/2024 to 31/12/2024.
26/04/2024: The primary and secondary outcome measures were updated. The intention to publish date was changed from 31/12/2023 to 30/06/2024.
20/04/2023: Total final enrolment added.
08/09/2022: The intention to publish date was changed from 31/12/2022 to 31/12/2023.
04/07/2022: Publication reference added.
20/04/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2022 to 30/09/2022.
2. The public title was changed from 'BrainFit-Nutrition: Intervention study for people suffering from mild cognitive impairment using computerized cognitive training tools and a nutrition intervention' to 'BrainFit-Nutrition: Intervention study for people with mild cognitive impairment using computerised cognitive training tools and a nutrition intervention'.
3. The scientific title was changed from 'Computerised cognitive training tools and online nutritional group counselling for people suffering from mild cognitive impairment: Study protocol of a completely digital, randomised, controlled clinical trial' to 'Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: Study protocol of a completely digital, randomised, controlled trial'.
29/12/2021: The following changes have been made:
1. The scientific title has been changed from "BrainFit-Nutrition: Individualized computerized cognitive training and nutrition intervention for community-dwelling people with mild cognitive impairment" to "Computerised cognitive training tools and online nutritional group counselling for people suffering from mild cognitive impairment: Study protocol of a completely digital, randomised, controlled clinical trial".
2. The study hypothesis has been changed.
3. The recruitment start date has been changed from 07/12/2021 to 03/01/2022.
06/12/2021: The primary and secondary outcome measures were updated.
24/11/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 03/01/2022 to 07/12/2021.
2. The recruitment end date was changed from 30/06/2022 to 30/06/2022.
3. The inclusion criteria and secondary outcome measures were updated.
22/10/2021: Trial's existence confirmed by the Friedrich-Alexander-University Erlangen-Nürnberg Ethics Committee.
