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

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).

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Inflammation; Malnutrition; Dyslipidemias
• Intervention / Treatment: Other: Novel food snack; Other: Placebo snack

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).

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Pavia, Lombardia, Italy, 27100
      • University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active group; Snack enriched with camelina sativa oil	Other: Novel food snack; Consumption of snack enriched with camelina sativa oil, twice a day for 12 weeks
Placebo Comparator: Placebo group; Snack no enriched with camelina sativa oil	Other: Placebo snack; Consumption of placebo snack (no enriched with camelina sativa oil), twice a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid panel parameters evaluation.	Evaluation of changes in serum lipid panel parameters (total cholesterol, mg/dL; triglycerides, mg/dL; HDL cholesterol, mg/dL; LDL cholesterol, mg/dL).	Baseline (T0) and after 12 weeks of intervention (T1).
Omega 3 polyunsaturated fatty acids evaluation.	Evaluation of changes in the levels of omega 3 polyunsaturated fatty acids.	Baseline (T0) and after 12 weeks of intervention (T1).
Glucidic profile evaluation -glucose levels	Evaluation of changes in the levels of glucose (mg/dL)	Baseline (T0) and after 12 weeks of intervention (T1).
Glucidic profile evaluation - insulin levels	Evaluation of changes in the levels of insulin (μU/mL).	Baseline (T0) and after 12 weeks of intervention (T1).
Glucidic profile evaluation - glycated haemoglobin levels	Evaluation of changes in the levels of glycated haemoglobin (mmol/mol).	Baseline (T0) and after 12 weeks of intervention (T1).
Glucidic profile evaluation - HOMA index	Evaluation of changes in the HOMA index.	Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - hepatic function	Evaluation of nutritional status by assessing the serum levels of ALT (U/L), AST (U/L).	Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - renal function	Evaluation of nutritional status by assessing the serum levels of creatinine (mg/dL).	Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation.	Evaluation of nutritional status by assessing the serum levels of prealbumin (g/L).	Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - micronutrients	Evaluation of nutritional status by assessing the calcium (mg/dL), magnesium (mg/dL).	Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - micronutrients	Evaluation of nutritional status by assessing the serum levels of iron (μg/dL) and zinc (μg/dL)	Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - vitamins	Evaluation of nutritional status by assessing the serum levels of vitamin B9 (ng/mL) and vitamin D (ng/mL).	Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - vitamins	Evaluation of nutritional status by assessing the serum levels of vitamin B12 (pg/mL).	Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - hyperhomocysteinemia	Evaluation of nutritional status by assessing the serum levels of Homocysteine (μM).	Baseline (T0) and after 12 weeks of intervention (T1).
Anthropometric parameters evaluation - weight	Evaluation at baseline of weight (Kg).	Baseline (T0).
Anthropometric parameters evaluation - height and waist circumference	Evaluation at baseline of height (cm) and waist circumference (cm).	Baseline (T0).
Ponderal status evaluation	Evaluation at baseline of Body Mass Index (Kg/m2) to investigate the prevalence of overweight or obesity.	Baseline (T0).
Fat distribution evaluation.	Evaluation at baseline of Waist to height ratio (WHtR) as a proxy of fat distribution and metabolic diseases risk.	Baseline (T0).
Body composition evaluation.	Evaluation at baseline of reactance (Ohm) and resistance (Ohm) by using vectorial bioimpedance analysis.	Baseline (T0).
Muscle strength evaluation.	Evaluation at baseline of muscle strength (Kg) by using a handgrip-dynamometer.	Baseline (T0).

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Hellas Cena, MD, Prof., University of Pavia

Publications and helpful links

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Older Adults; Inflammaging; Omega-3 fatty acid; Healthy aging; Camelina Sativa; Micronutrients deficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nutrition Disorders; Lipid Metabolism Disorders; Hyperglycemia; Inflammation; Dyslipidemias; Malnutrition
• Other Study ID Numbers: 14012021; E47F17000020009 (Other Identifier: Grantor or Funder: Regione Lombardia - POR FESR 2014-2020)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No