InflammationNCT04965948
Effects of Camelina Sativa Oil in Free-living Older Adults
A study testing Novel food snack in people with Inflammation and Malnutrition, run by University of Pavia at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Malnutrition, Hyperglycemia
- What is being tested?
- Novel food snack
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age over 65
- Free-living
- No food allergy
- Apparent good health
- Acceptance and sign of informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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:
- 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).
- Evaluation of the nutritional status at T0 and at T1 in both the active and placebo groups (secondary endpoint).
- Conditions
- Inflammation, Malnutrition, Hyperglycemia, Dyslipidemias
- Being tested
- Novel food snack, Placebo snack
- Keywords
- Inflammaging, Healthy aging, Older Adults, Omega-3 fatty acid, Camelina Sativa, Inflammation, Micronutrients deficiency
- Medical subject headings
- Inflammation, Malnutrition, Hyperglycemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel food snackOther
Consumption of snack enriched with camelina sativa oil, twice a day for 12 weeks
Placebo snackOther
Consumption of placebo snack (no enriched with camelina sativa oil), twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Snack enriched with camelina sativa oil Receives: Other: Novel food snack |
| Placebo group | Placebo comparator | Snack no enriched with camelina sativa oil Receives: Other: Placebo snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (T0) and after 12 weeks of intervention (T1).
Secondary outcomes (20)
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).
Measured: 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.
Measured: Baseline (T0) and after 12 weeks of intervention (T1).
Glucidic profile evaluation -glucose levels
Evaluation of changes in the levels of glucose (mg/dL)
Measured: Baseline (T0) and after 12 weeks of intervention (T1).
Glucidic profile evaluation - insulin levels
Evaluation of changes in the levels of insulin (μU/mL).
Measured: 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).
Measured: Baseline (T0) and after 12 weeks of intervention (T1).
Glucidic profile evaluation - HOMA index
Evaluation of changes in the HOMA index.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (T0) and after 12 weeks of intervention (T1).
Anthropometric parameters evaluation - weight
Evaluation at baseline of weight (Kg).
Measured: Baseline (T0).
Anthropometric parameters evaluation - height and waist circumference
Evaluation at baseline of height (cm) and waist circumference (cm).
Measured: Baseline (T0).
Ponderal status evaluation
Evaluation at baseline of Body Mass Index (Kg/m2) to investigate the prevalence of overweight or obesity.
Measured: Baseline (T0).
Fat distribution evaluation.
Evaluation at baseline of Waist to height ratio (WHtR) as a proxy of fat distribution and metabolic diseases risk.
Measured: Baseline (T0).
Body composition evaluation.
Evaluation at baseline of reactance (Ohm) and resistance (Ohm) by using vectorial bioimpedance analysis.
Measured: Baseline (T0).
Muscle strength evaluation.
Evaluation at baseline of muscle strength (Kg) by using a handgrip-dynamometer.
Measured: Baseline (T0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start7 Jan 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hellas Cena, MD, Prof., Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965948
- Sponsor's protocol ID
- 14012021
- Other IDs
- E47F17000020009
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37357331
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04965948
- Acronym / sponsor ID
- 14012021
- Conditions
- Inflammation, Malnutrition, Hyperglycemia, Dyslipidemias
- Keywords
- Inflammaging, Healthy aging, Older Adults, Omega-3 fatty acid, Camelina Sativa, Inflammation, Micronutrients deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- Evaluation of the nutritional status at T0 and at T1 in both the active and placebo groups (secondary endpoint).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Other: Novel food snackSnack enriched with camelina sativa oil |
| Placebo group | Placebo comparator | Other: Placebo snackSnack no enriched with camelina sativa oil |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age over 65
- Free-living
- No food allergy
- Apparent good health
- Acceptance and sign of informed consent
Key exclusion criteria (6 listed)
- Age under 65
- Living in a nursing home, extended care
- Hospitalized
- Presence food allergy
- Without acceptance and sign of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel food snackConsumption of snack enriched with camelina sativa oil, twice a day for 12 weeks | Other | Active group |
| Placebo snackConsumption of placebo snack (no enriched with camelina sativa oil), twice a day for 12 weeks | Other | Placebo group |
Primary outcome
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).
20 secondary outcomes
Lipid panel parameters evaluation.
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Omega 3 polyunsaturated fatty acids evaluation.
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Glucidic profile evaluation -glucose levels
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Glucidic profile evaluation - insulin levels
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Glucidic profile evaluation - glycated haemoglobin levels
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Glucidic profile evaluation - HOMA index
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - hepatic function
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - renal function
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation.
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - micronutrients
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - micronutrients
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - vitamins
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - vitamins
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Nutritional status evaluation - hyperhomocysteinemia
Time frame: Baseline (T0) and after 12 weeks of intervention (T1).
Anthropometric parameters evaluation - weight
Time frame: Baseline (T0).
Anthropometric parameters evaluation - height and waist circumference
Time frame: Baseline (T0).
Ponderal status evaluation
Time frame: Baseline (T0).
Fat distribution evaluation.
Time frame: Baseline (T0).
Body composition evaluation.
Time frame: Baseline (T0).
Muscle strength evaluation.
Time frame: Baseline (T0).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Derived from this study: PubMed 37357331De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hellas Cena, MD, Prof. principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel food snack in people with Inflammation and Malnutrition, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory status evaluation. (time frame: Baseline (T0) and after 12 weeks of intervention (T1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.