NCT04965948

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

July 1, 2021

Last Update Submit

July 15, 2021

Conditions

InflammationMalnutritionHyperglycemiaDyslipidemias

Keywords

InflammagingHealthy agingOlder AdultsOmega-3 fatty acidCamelina SativaInflammationMicronutrients deficiency

Outcome Measures

Primary Outcomes (1)

  • Inflammatory status evaluation.

    Investigation of changes in serum CRP levels (pg/mL) and serum levels of pro- and anti- inflammatory cytokines (TNF-α, pg/mL; TGF-beta1, pg/mL and TGF-beta2, pg/mL; IL-18 pg/mL).

    Baseline (T0) and after 12 weeks of intervention (T1).

Secondary Outcomes (20)

  • Lipid panel parameters evaluation.

    Baseline (T0) and after 12 weeks of intervention (T1).

  • Omega 3 polyunsaturated fatty acids evaluation.

    Baseline (T0) and after 12 weeks of intervention (T1).

  • Glucidic profile evaluation -glucose levels

    Baseline (T0) and after 12 weeks of intervention (T1).

  • Glucidic profile evaluation - insulin levels

    Baseline (T0) and after 12 weeks of intervention (T1).

  • Glucidic profile evaluation - glycated haemoglobin levels

    Baseline (T0) and after 12 weeks of intervention (T1).

  • +15 more secondary outcomes

Study Arms (2)

Active group

EXPERIMENTAL

Snack enriched with camelina sativa oil

Other: Novel food snack

Placebo group

PLACEBO COMPARATOR

Snack no enriched with camelina sativa oil

Other: Placebo snack

Interventions

Novel food snackOTHER

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

Active group
Placebo snackOTHER

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

Placebo group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pavia

Pavia, Lombardy, 27100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 37357331DERIVED

MeSH Terms

Conditions

InflammationMalnutritionHyperglycemiaDyslipidemias

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesGlucose Metabolism DisordersMetabolic DiseasesLipid Metabolism Disorders

Study Officials

  • Hellas Cena, MD, Prof.

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 16, 2021

Study Start

January 7, 2019

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

July 16, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)