Nutri-Mo-Food: Molybdenum Fortification Trial

This research is part of the larger project, Nutri-Mo-Food, that is registered at Clinicaltrials.gov (accessed on 12 February 2023) with the approbation number NCT04985240. The protocol, conducted in accordance with the Declaration of Helsinki, was approved by the Palermo University Hospital Ethics Committee, and the approbation number is 2/2020 AIFA CE 150109. From an initial 95 subjects (47 adults age range 23–54 and 48 seniors age range 55–73), on the basis of the eligibility criteria, 11 subjects were excluded (5 in the adults and 6 in the senior group), and 84 subjects (42 adults comprising 25 males and 17 females and 42 seniors comprising 24 males and 18 females) were randomized into the control group, the Mo-tablet and the biofortified group for a total of 14 subjects in each group of adults and seniors (Figure 1). The participants at the study, the medical staff and the investigator staff were blinded to the allocation during the whole period of data collection. The investigators were also blinded during the sample assessment and data analysis. The control group received 100 g of lettuce and the intervention group received 100 g of Mo-fortified lettuce to consume every day for a total of 12 days. The molybdenum supplementation tablet (150 µg/tablet) was purchased from Zein-pharma (Germany). The Mo-tablet group received one tablet of Mo to consume daily for a total of 12 days. Samples of blood were collected before (T0) and at the end (T1) of the trial, after 12 days (Figure 2).
Exclusion and inclusion criteria are reported in Table 1.
In the first visit, the subjects underwent anthropometric measurement and completed a habitual dietary intake assessment [23 (link)]. Participants were recommended not to change their habits and diet during the study period, which was reiterated throughout the study. Body composition (fat and lean mass) was measured by electrical bioimpedance measurements (InBody 320 Body Composition Analyzer). Barefoot standing height and body weight were measured by using a wall-mounted stadiometer (Gima 27088, Italy) and an electronic scale (Gima 27335) [30 (link)]. Body mass index (BMI) was reported as weight, measured in kilograms, per standing height, measured as meters squared.