Effects of Camelina Sativa Oil in Free-living Older Adults

Not Applicable

Completed

• Conditions: Inflammation; Hyperglycemia; Dyslipidemias; Malnutrition
• Interventions: Other: Placebo snack; Other: Novel food snack

• Registration Number: NCT04965948
• Lead Sponsor: University of Pavia

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).

Study Timeline

• Study Start: 2019-01-07
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-07
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-15
• Last Update Submitted: 2021-07-15
• Study First Posted: 2021-07-16
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo snack	Snack no enriched with camelina sativa oil
Active group	Novel food snack	Snack enriched with camelina sativa oil

Primary Outcome Measures

Name	Time	Method
Inflammatory status evaluation.	Baseline (T0) and after 12 weeks of intervention (T1).	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pavia; 🇮🇹 Pavia, Lombardia, Italy