Received: 10 March 2020
Accepted: 15 June 2020
First Online: 24 June 2020
Change Date: 4 November 2020
Change Type: Correction
Change Details: An amendment to this paper has been published and can be accessed via the original article.
Ethics approval and consent to participate
: The study will be performed in accordance with the Declaration of Helsinki and was approved by the Medical Research Ethics Committee of the Leiden University Medical Center (METC Leiden-Den Haag-Delft) on the 20th of September of 2018. Identifiers: P18.049 and NL63892.058.18; protocol: version 3.0, 25th of July of 2018.Current version of the protocol: version 5.0, 8th of November of 2019. Since the start of the trial, some minor procedural changes have been made to the protocol. A change in secondary outcomes is that the stool sample is now also collected after 1 week, in addition to baseline, after 6 months and after 12 months. No changes have been made in eligibility criteria, intervention, primary outcomes or analyses. These changes have been approved by the Medical Research Ethics Committee of the Leiden University Medical Center (METC Leiden-Den Haag-Delft).Participants have to provide written informed consent for participation in the trial before screening. The first patient was included on the 5th of November of 2018. Recruitment is ongoing at the time of submission of the study protocol.
: Not applicable.
: Health~Holland, the Dutch Diabetes Foundation and L-Nutra, as the funders, have no role in the design or conduct of the study nor in the preparation, review or approval of the manuscripts.VL is founder and shareholder of L-Nutra; his shares are destined to the Create Cures Foundation and other charitable and research organizations. HP has shares in a company that has invested in L-Nutra.