Dyslipidemias, Hyperglycemia, Inflammation, Malnutrition
Conditions
Keywords
Inflammaging, Healthy aging, Older Adults, Omega-3 fatty acid, Camelina Sativa, Inflammation, Micronutrients deficiency
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).
Interventions
OTHERNovel food snack
Consumption of snack enriched with camelina sativa oil, twice a day for 12 weeks
OTHERPlacebo snack
Consumption of placebo snack (no enriched with camelina sativa oil), twice a day for 12 weeks
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Glucidic profile evaluation -glucose levels | Baseline (T0) and after 12 weeks of intervention (T1). | Evaluation of changes in the levels of glucose (mg/dL) |
| 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). |
| 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). |
| 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). |
| Glucidic profile evaluation - HOMA index | Baseline (T0) and after 12 weeks of intervention (T1). | Evaluation of changes in the HOMA index. |
| 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). |
| 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). |
| 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 B9 (ng/mL) and vitamin D (ng/mL). |
| 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). |
| Anthropometric parameters evaluation - weight | Baseline (T0). | Evaluation at baseline of weight (Kg). |
| 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. |
| Fat distribution evaluation. | Baseline (T0). | Evaluation at baseline of Waist to height ratio (WHtR) as a proxy of fat distribution and metabolic diseases risk. |
| Body composition evaluation. | Baseline (T0). | Evaluation at baseline of reactance (Ohm) and resistance (Ohm) by using vectorial bioimpedance analysis. |
| Muscle strength evaluation. | Baseline (T0). | Evaluation at baseline of muscle strength (Kg) by using a handgrip-dynamometer. |
| Nutritional status evaluation - micronutrients | Baseline (T0) and after 12 weeks of intervention (T1). | Evaluation of nutritional status by assessing the calcium (mg/dL), magnesium (mg/dL). |
Countries
Italy
Outcome results
None listed