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| ID | Type | Description | Link |
|---|---|---|---|
| E47F17000020009 | Other Identifier | Grantor or Funder: Regione Lombardia - POR FESR 2014-2020 |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Experimental | Snack enriched with camelina sativa oil |
|
| Placebo group | Placebo Comparator | Snack no enriched with camelina sativa oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel food snack | Other | Consumption of snack enriched with camelina sativa oil, twice a day for 12 weeks |
|
| 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). |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hellas Cena, MD, Prof. | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pavia | Pavia | Lombardy | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37357331 | Derived | 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. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D044342 | Malnutrition |
| D006943 | Hyperglycemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo snack | Other | Consumption of placebo snack (no enriched with camelina sativa oil), twice a day for 12 weeks |
|
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). |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |