Clinical trial NCT04965948: Effects of Camelina Sativa Oil in Free-living Older Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Malnutrition
Hyperglycemia
Dyslipidemias
Keywords: Inflammaging
Healthy aging
Older Adults
Omega-3 fatty acid
Camelina Sativa
Inflammation
Micronutrients deficiency
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 135
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Inflammatory status evaluation.
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
Secondary outcomes:
measure: Lipid panel parameters evaluation.
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Omega 3 polyunsaturated fatty acids evaluation.
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Glucidic profile evaluation -glucose levels
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Glucidic profile evaluation - insulin levels
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Glucidic profile evaluation - glycated haemoglobin levels
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Glucidic profile evaluation - HOMA index
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Nutritional status evaluation - hepatic function
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Nutritional status evaluation - renal function
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Nutritional status evaluation.
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Nutritional status evaluation - micronutrients
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Nutritional status evaluation - micronutrients
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Nutritional status evaluation - vitamins
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Nutritional status evaluation - vitamins
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Nutritional status evaluation - hyperhomocysteinemia
timeFrame: Baseline (T0) and after 12 weeks of intervention (T1).
measure: Anthropometric parameters evaluation - weight
timeFrame: Baseline (T0).
measure: Anthropometric parameters evaluation - height and waist circumference
timeFrame: Baseline (T0).
measure: Ponderal status evaluation
timeFrame: Baseline (T0).
measure: Fat distribution evaluation.
timeFrame: Baseline (T0).
measure: Body composition evaluation.
timeFrame: Baseline (T0).
measure: Muscle strength evaluation.
timeFrame: Baseline (T0).
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: University of Pavia
state: Lombardia
Study officials:
affiliation: University of Pavia
name: Hellas Cena, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: