Effects of Camelina Sativa Oil in Free-living Older Adults

NCT ID: NCT04965948

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2021-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Active group

Snack enriched with camelina sativa oil

Group Type: EXPERIMENTAL

Novel food snack

Intervention Type: OTHER

Consumption of snack enriched with camelina sativa oil, twice a day for 12 weeks

Placebo group

Snack no enriched with camelina sativa oil

Group Type: PLACEBO_COMPARATOR

Placebo snack

Intervention Type: OTHER

Consumption of placebo snack (no enriched with camelina sativa oil), twice a day for 12 weeks

Interventions

Novel food snack

Consumption of snack enriched with camelina sativa oil, twice a day for 12 weeks

Intervention Type: OTHER

Placebo snack

Consumption of placebo snack (no enriched with camelina sativa oil), twice a day for 12 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age over 65
• Free-living
• No food allergy
• Apparent good health
• Acceptance and sign of informed consent

Exclusion Criteria

• Age under 65
• Living in a nursing home, extended care
• Hospitalized
• Presence food allergy
• Without acceptance and sign of informed consent
• Taking vitamin supplements/integration and/or omega 3 polyunsaturated fatty acids

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hellas Cena, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

University of Pavia

Pavia, Lombardy, Italy

Countries

Italy

References

De Giuseppe R, Di Napoli I, Tomasinelli CE, Vincenti A, Biino G, Sommella E, Ferron L, Campiglia P, Ferrara F, Casali PM, Cena H. The Effect of Crackers Enriched with Camelina Sativa Oil on Omega-3 Serum Fatty Acid Composition in Older Adults: A Randomized Placebo-Controlled Pilot Trial. J Nutr Health Aging. 2023;27(6):463-471. doi: 10.1007/s12603-023-1925-x.

Reference Type: DERIVED

PMID: 37357331 (View on PubMed)

Other Identifiers

E47F17000020009

Identifier Type: OTHER

Identifier Source: secondary_id

14012021

Identifier Type: -

Identifier Source: org_study_id