2.3. Study design
The study was a parallel, randomized, controlled, intervention
study in free-living subjects (Fig. 1). Subjects were randomly
assigned to one of two groups for 12 weeks: control breakfast or PB.
The sole intervention of this study was the instruction to eat a
breakfast composed of healthy Nordic foods, in accordance with
Nordic dietary recommendations [13]. Participants in the PB were
provided with all breakfast items. Beverages were, however, not
provided to the PB. The intervention group was encouraged to
otherwise maintain their usual lifestyle. The control group was
encouraged to maintain their usual breakfast habits and maintain
their usual dietary or lifestyle habits during the study. The subjects
in the control group were offered the PB for 3 weeks after
completing the study. This offer was made in an attempt to
decrease the number of drop-outs in the control group.
Subjects that met the eligibility criteria and signed the informed
consent were assigned a randomization number. Randomization
was performed by personnel at Good Food Practice (GFP). A study
nurse enrolled and assigned participants into the study in accor-
dance with the randomization procedure. A randomization treat-
ment code list was generated by an independent contract research
organization (Good Food Practice), unavailable to all study in-
vestigators. The first eligible subject received the first number in
the randomization number list, and the second subject received the
second number, and so on. The investigational products were sent to GFP and were stored at GFP until distribution. The protocol for
this trial and supporting CONSORT checklist are available as
Supporting information.