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Completed

NCT Number: NCT04965948

Effects of Camelina Sativa Oil in Free-living Older Adults

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pavia

Pavia, Lombardy, 27100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novel food snack

Other

Consumption of snack enriched with camelina sativa oil, twice a day for 12 weeks

Placebo snack

Other

Consumption of placebo snack (no enriched with camelina sativa oil), twice a day for 12 weeks

Primary outcomes

  1. Inflammatory status evaluation.

    Time frame: 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 outcomes

  1. Lipid panel parameters evaluation.

    Time frame: 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).

  2. Omega 3 polyunsaturated fatty acids evaluation.

    Time frame: Baseline (T0) and after 12 weeks of intervention (T1).

    Evaluation of changes in the levels of omega 3 polyunsaturated fatty acids.

  3. Glucidic profile evaluation -glucose levels

    Time frame: Baseline (T0) and after 12 weeks of intervention (T1).

    Evaluation of changes in the levels of glucose (mg/dL)

  4. Glucidic profile evaluation - insulin levels

    Time frame: Baseline (T0) and after 12 weeks of intervention (T1).

    Evaluation of changes in the levels of insulin (μU/mL).

  5. Glucidic profile evaluation - glycated haemoglobin levels

    Time frame: Baseline (T0) and after 12 weeks of intervention (T1).

    Evaluation of changes in the levels of glycated haemoglobin (mmol/mol).

  6. Glucidic profile evaluation - HOMA index

    Time frame: Baseline (T0) and after 12 weeks of intervention (T1).

    Evaluation of changes in the HOMA index.

  7. Nutritional status evaluation - hepatic function

    Time frame: 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).

  8. Nutritional status evaluation - renal function

    Time frame: Baseline (T0) and after 12 weeks of intervention (T1).

    Evaluation of nutritional status by assessing the serum levels of creatinine (mg/dL).

  9. Nutritional status evaluation.

    Time frame: Baseline (T0) and after 12 weeks of intervention (T1).

    Evaluation of nutritional status by assessing the serum levels of prealbumin (g/L).

  10. Nutritional status evaluation - micronutrients

    Time frame: Baseline (T0) and after 12 weeks of intervention (T1).

    Evaluation of nutritional status by assessing the calcium (mg/dL), magnesium (mg/dL).

  11. Nutritional status evaluation - micronutrients

    Time frame: 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)

  12. Nutritional status evaluation - vitamins

    Time frame: 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).

  13. Nutritional status evaluation - vitamins

    Time frame: Baseline (T0) and after 12 weeks of intervention (T1).

    Evaluation of nutritional status by assessing the serum levels of vitamin B12 (pg/mL).

  14. Nutritional status evaluation - hyperhomocysteinemia

    Time frame: Baseline (T0) and after 12 weeks of intervention (T1).

    Evaluation of nutritional status by assessing the serum levels of Homocysteine (μM).

  15. Anthropometric parameters evaluation - weight

    Time frame: Baseline (T0).

    Evaluation at baseline of weight (Kg).

  16. Anthropometric parameters evaluation - height and waist circumference

    Time frame: Baseline (T0).

    Evaluation at baseline of height (cm) and waist circumference (cm).

  17. Ponderal status evaluation

    Time frame: Baseline (T0).

    Evaluation at baseline of Body Mass Index (Kg/m2) to investigate the prevalence of overweight or obesity.

  18. Fat distribution evaluation.

    Time frame: Baseline (T0).

    Evaluation at baseline of Waist to height ratio (WHtR) as a proxy of fat distribution and metabolic diseases risk.

  19. Body composition evaluation.

    Time frame: Baseline (T0).

    Evaluation at baseline of reactance (Ohm) and resistance (Ohm) by using vectorial bioimpedance analysis.

  20. Muscle strength evaluation.

    Time frame: Baseline (T0).

    Evaluation at baseline of muscle strength (Kg) by using a handgrip-dynamometer.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2021
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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