NCT04965948

Effects of Camelina Sativa Oil in Free-living Older Adults

Evaluation of the Anti-inflammatory Effects of a Snack Enriched With Camelina Sativa Oil in Free-living Older Adults: a Randomized, Double-blind, Placebo-controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The present study aims at evaluating the anti-inflammatory effects of a novel food in older adult volunteers. Briefly, this randomized, double-blind and placebo-controlled study is performed on 91 apparently healthy older adults (age≥65 years) before and after 12 weeks' consumption of a snack enriched with camelina Sativa oil. Subjects were randomized into two groups (active group vs placebo group).

Detailed description

Ninety-one volunteers (26M/65F) are enrolled according to the following inclusion criteria i) free-living older adults ≥ 65 years; ii) apparently healthy subjects; iii) subjects who do not take vitamin supplements/integration and/or omega 3 polyunsaturated fatty acids; iv) subjects without food allergies. All volunteers are informed about the purpose of the study and the potential risk and provide their informed consent. Subjects are randomized into two groups: active group (13M/36F) vs placebo group (13M/29F). The main objective of this project is to test the efficacy of the 12-weeks consumption of a novel food (snack enriched with camelina Sativa oil) on the inflammatory status in older adults. The primary and secondary endpoints are: i) Investigation of changes in serum CRP levels and serum levels of pro- and anti-inflammatory cytokines, in the active group (volunteers consumed enriched snack with camelina Sativa oil) and placebo group, after 12 weeks of snacking (T1), compared to baseline (T0) (primary endpoint). ii) Evaluation of changes in serum lipid panel parameters after the consumption of the novel food in both the active and placebo groups (secondary endpoint). iii) Evaluation of changes in glucidic status after the consumption of the novel food in both the active and placebo groups (secondary endpoint). iv) Evaluation of changes in the levels of omega 3 polyunsaturated fatty acids in both the active and placebo groups (secondary endpoint). v) Evaluation of the nutritional status at T0 and at T1 in both the active and placebo groups (secondary endpoint).

Conditions

• Inflammation
• Malnutrition
• Hyperglycemia
• Dyslipidemias

Interventions

Type	Name	Description
OTHER	Novel food snack	Consumption of snack enriched with camelina sativa oil, twice a day for 12 weeks
OTHER	Placebo snack	Consumption of placebo snack (no enriched with camelina sativa oil), twice a day for 12 weeks

Timeline

• Start date: 2019-01-07
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2021-07-16
• Last updated: 2021-07-16

Locations

1 site across 1 country: Italy