Study design
The participants were randomly assigned (1:1 ratio) into an experimental group or a control group, as shown in Figure. Camelina group (11M/23 F; mean age±SD: 71,08 ± 4,75 years);Placebo group (10M/22 F; mean age±SD: 70,03 ± 4,25 years).Study designT0, baseline; T1, after 12 weeks.Subjects in the Camelina group were instructed to consume Camelina sativa oil-enriched crackers (35 g twice daily for 12 weeks), while subjects in the control group were instructed to consume the same amount of placebo (same quantity of cracker without Camelina sativa oil for the same time) (Figure Personal identity and all personal medical information were kept confidential. Each participant was assigned a unique ID number. Participants were randomized using random numbers generated by a uniform distribution. Intervention and sample codification was hidden from both investigators and volunteers (double-blind study) and kept exclusively by the Principal Investigator (PI).The energy and nutrient compositions of placebo and Camelina crackers are presented in Table Average nutritional values for 100 g of Camelina sativa oil crackers and 100 g of placebo crackers*Average nutritional values for 100 g of Camelina sativa oil: Energy 460 kcal; Saturated fatty acids 10.09 g; Monounsaturated fatty acids 30.7 g; Polyunsaturated fatty acids 56.92 g; Linoleic acid 16.3 g; α-Linolenic acid 36.46 g; Erucic acid 3.34 g; Vitamin E 0.115 g.In brief, pure cold-pressed Camelina sativa oil (nutritional values are presented in Supplementary Table S1) was obtained from seeds (Camelina Sativa L. Crantz REF. 18-C43-S) cultivated in Cremona (Italy) by FLANAT Research Italia (Rho - Milano, Italy). Crackers with Camelina sativa oil were formulated and manufactured by FLANAT Research Italia s.r.l. and packaged in transparent plastic bags containing 35 grams of crackers. A daily serving of Camelina sativa oil crackers provided approximately 2.6 g of ALA in toto. The placebo crackers formulation was chosen to match the carbohydrates, proteins, lipids, fibres, salt and energy (kcal) of Camelina sativa oil crackers. Crackers were packaged indistinguishably and labelled with the participant’s ID number.Compliance with the study protocol was determined by assessing the uneaten cracker packages after 12 weeks. To prevent dropouts, a member of the research team was assigned the task to email, calling, and text messaging the participants during the whole study.Anthropometric data (e.g., weight, height, waist circumference), body composition, epicardial fat, as well as dietary habits and lifestyle factors (e.g., physical activity, drug intake, smoking habit) were evaluated by professionally trained staff at baseline (T0) to describe anthropometry and lifestyle of the study population. Biochemical parameters, including serum polyunsaturated fatty acid profile, inflammatory status parameters and serum lipid panel parameters were measured at T0 and after 12 weeks of the functional food consumption (T1), to complete the assessment of nutritional status.