Effects of Camelina Sativa Oil in Free-living Older Adults

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Inflammation, Malnutrition, Hyperglycemia, Dyslipidemias

Intervention / Treatment
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* Other: Novel food snack
* Other: Placebo snack


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammaging, Healthy aging, Older Adults, Omega-3 fatty acid, Camelina Sativa, Inflammation, Micronutrients deficiency