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. 2022 Jul 1;12(7):e060473. doi: 10.1136/bmjopen-2021-060473

Table 1.

Trial registration data

Data category Information
1. Primary registry and trial identification no ISRCTN
2. Date of registration in primary registry 23 November 2021
3. Secondary identifying numbers –
4. Source(s) of monetary or material support Karl and Veronica Carstens-Stiftung
5. Primary sponsor Karl and Veronica Carstens-Stiftung
6. Secondary sponsor(s) –
7. Contact for public queries see point 8
8. Contact for scientific queries Prof. Dr. Elmar Graessel, elmar.graessel@uk-erlangen.de
PD Dr. Christian Kessler, M.A., christian.kessler@charite.de
9. Public title BrainFit-Nutrition: Intervention study for people with mild cognitive impairment (MCI) using computerised cognitive training (CCT) tools and a nutrition intervention
10.Scientific title CCT tools and online nutritional group counselling for people with MCI: Study protocol of a completely digital, randomised, controlled trial
11.Countries of recruitment Germany
12.Health condition(s) or problem(s) studied MCI
13.Intervention(s) Participants will be randomly allocated to one of four groups with two intervention variables (BrainFit and Nutrition):

  1. BrainFit: two versions of CCT: individualised CCT, which involves targeted exercises for memory span, information processing, visual-spatial cognition, etc; and basic CCT, which involves basic exercises for memory span, information processing, visual-spatial cognition, etc.

  2. Nutrition: two types of nutritional interventions: a WFPB diet and a healthy diet recommended by the German Nutrition Society.
14.Key inclusion and exclusion criteria Inclusion criteria:

  1. MCI

    • Montreal Cognitive Assessment score (MoCA) ≤24

    • Mini-Mental State Examination score (MMSE) ≥24

  2. The digital applications and examinations require a PC with 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

  4. Informed consent given
Exclusion criteria:

  1. Completely blind or deaf

  2. No personal computer, laptop, or tablet

  3. Normal cognition, MoCA >24

  4. Dementia, MMSE score <24

  5. Depression, Patient Health Questionnaire 9 (PHQ-9) score ≥12

  6. Diagnosis of another disease that causes cognitive impairment:

    • Psychosis (schizophrenia, mania, bipolar psychosis)

    • Morbus Parkinson

    • Multiple sclerosis

    • Multiple strokes

    • Alcohol abuse/drug consummation (addiction)

    • Severe brain disease (tumour, injury, hydrocephalus)

    • Severe vitamin B deficiencies

15.Study type Prospective double-blind randomised controlled clinical intervention study
16.Date of first enrolment Starting on 03 January 2022
17.Target sample size 200
18.Recruitment status Not yet recruiting
19.Primary outcome(s) Cognition measured by the MoCA at baseline and after 6 months
20.Key secondary outcome(s) Cognitive Function measured by the MMSE at baseline and after 6 and 12 months
Cognition measured by the computerised cognitive test battery integrated in the digital software at baseline and after 6 and 12 months
Depression measured by the PHQ-9 at baseline and after 6 and 12 months
Activities of daily living (ADL) measured by the Bayer ADLs Scale (B-ADL) at baseline and after 6 and 12 months

WFPB, whole-food, plant-based.