Effects of Camelina Sativa Oil in Free-living Older Adults

Inflammation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965948
• Other study ID #: 14012021
• Secondary ID: E47F17000020009
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2021
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperglycemia
• Inflammation
• Malnutrition

Intervention

Other:
• Novel food snack
Consumption of snack enriched with camelina sativa oil, twice a day for 12 weeks
• Placebo snack
Consumption of placebo snack (no enriched with camelina sativa oil), twice a day for 12 weeks

Locations

Country	Name	City	State
Italy	University of Pavia	Pavia	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory status evaluation.	Investigation of changes in serum CRP levels (pg/mL) and serum levels of pro- and anti- inflammatory cytokines (TNF-a, 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	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).
Secondary	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).
Secondary	Glucidic profile evaluation -glucose levels	Evaluation of changes in the levels of glucose (mg/dL)	Baseline (T0) and after 12 weeks of intervention (T1).
Secondary	Glucidic profile evaluation - insulin levels	Evaluation of changes in the levels of insulin (µU/mL).	Baseline (T0) and after 12 weeks of intervention (T1).
Secondary	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).
Secondary	Glucidic profile evaluation - HOMA index	Evaluation of changes in the HOMA index.	Baseline (T0) and after 12 weeks of intervention (T1).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	Anthropometric parameters evaluation - weight	Evaluation at baseline of weight (Kg).	Baseline (T0).
Secondary	Anthropometric parameters evaluation - height and waist circumference	Evaluation at baseline of height (cm) and waist circumference (cm).	Baseline (T0).
Secondary	Ponderal status evaluation	Evaluation at baseline of Body Mass Index (Kg/m2) to investigate the prevalence of overweight or obesity.	Baseline (T0).
Secondary	Fat distribution evaluation.	Evaluation at baseline of Waist to height ratio (WHtR) as a proxy of fat distribution and metabolic diseases risk.	Baseline (T0).
Secondary	Body composition evaluation.	Evaluation at baseline of reactance (Ohm) and resistance (Ohm) by using vectorial bioimpedance analysis.	Baseline (T0).
Secondary	Muscle strength evaluation.	Evaluation at baseline of muscle strength (Kg) by using a handgrip-dynamometer.	Baseline (T0).

External Links

•   Project website