Low Risk for Cardiovascular DiseasePhase 4NCT01999088
Health Benefits of Functional Meat (With n-3 Fatty Acids and Rosemary Extract) on Low Risk for Cardiovascular Disease People
A Phase 4 study testing Functional Meet in people with Low Risk for Cardiovascular Disease, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Volunteers were randomly assigned by gender to follow of two 12 weeks experimental periods: intervention (I) and control (C) in different order (I/C or C/I). Both periods were separated by a 4 weeks wash-out interval during which subjects returned to their usual diet: During the I period, volunteers weekly consumed… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Risk for Cardiovascular Disease
- What is being tested?
- Functional Meet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- May 2009to Jun 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years
- At least 2 lipid profile parameters altered (TAG ≥150 mg /dl and/or total cholesterol ≥200 mg / dl and/or LDL ≥130 mg / dl and/or HDL ≥40mg/dl men or ≥ 50mg/dl women).
- Signed informed consent
Who cannot join
- Individuals with body mass index (BMI) ≥ 35 kg/m2
- Individuals with Diabetes Mellitus insulin dependent
- Individuals with disorders associated with eating behaviour
- Individuals with consumption of omega 3 functional foods, fish oil or antioxidant supplements
- Individuals inability to consume the test foods (ej. Vegetarians)
- Individuals with special diet due to disease as celiac disease, chronic renal failure, etc.
Show all 12Show fewer
- Individuals with mental disease or low cognitive function.
- Individuals with consumption of drugs to weight lost.
- Individuals treated with drugs whose direct effect is on lipid profile (statins, fibrates, diuretics, corticosteroids or oral anti-inflammatory).
- Individuals with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.).
- Pregnant women or lactating.
- Individuals with regular consumption of anti-inflammatory or glucocorticoids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Cross-over Placebo-controlled Study to Assess the Functional Meat Products With n-3 and Rosemary Extract Fluid in Biochemical Markers of Cardiovascular Disease Related Risk in Subjects at Low Risk for Cardiovascular Disease
Volunteers were randomly assigned by gender to follow of two 12 weeks experimental periods: intervention (I) and control (C) in different order (I/C or C/I). Both periods were separated by a 4 weeks wash-out interval during which subjects returned to their usual diet:
During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet.
Read more
During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).
Functional meat (FM) products (Functional cooked Ham (FH) and Functional cooked Turkey breast (FT)), were manufactured mixing the meats with the patented formula® (P200402755.2004). The amount of supercritical rosemary extract, deodorized salmon oil and vitamin E used was respectively, 0.02% w/w, 0.6% w/w, and 0.001% w/w.
Control meat (CM) products (Control cooked Ham (CH) and Control cooked Turkey (CT), were prepared without addition of the functional ingredients.
Read the detailed description
The total duration of the study was 28 weeks: first experimental period 0-12 weeks, washout period 12-16 weeks second experimental period 16-28 weeks:
- Conditions
- Low Risk for Cardiovascular Disease
- Being tested
- Functional Meet, Control Meat
- Keywords
- Fatty Acids, Omega-3, Rosemary extract, Functional meat, Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MeetOther
Also called Functional food
During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet.
Control MeatOther
Also called Control Food
During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).
| Study group | Role | What they receive |
|---|---|---|
| Functional meat | Experimental | During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet. Receives: Other: Functional Meet; Other: Control Meat |
| Control Meat | Placebo comparator | During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)). Receives: Other: Functional Meet; Other: Control Meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile changes
Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Apolipoprotein B and Apolipoprotein A.
Measured: 0, 12, 16 and 28 week
Secondary outcomes (6)
Framingham score changes
Framingham score adapted to Spanish population (cardiovascular risk measurement)
Measured: 0, 12, 16 and 28 week
Inflammatory markers changes
Parameters measured were: Adiponectin, fibrinogen, TNFα, IL6, IL1B, PAI-1 and PCR
Measured: 0, 12, 16 and 28 week
Oxidative Stress Parameters changes
Parameters measured were: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power), lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay), LDL-ox, . 8-iso-Prostaglandin F2α (8-iso-PGF2α), α-tocopherol and nitric oxide synthase (NOS).
Measured: 0, 12, 16 and 28 week
Glucosa Metabolism changes
Parameters measured were: glucose, basal insulin, HOMA index (glycemic insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22.5).
Measured: 0, 12, 16 and 28 week
Blood pressure and heart rate changes
Measured: 0, 12, 16 and 28 week
Anthropometric parameters changes
Parameters measured were: Weight, Height and waist circumference, tricipital skinfold thickness and fat mass percentage (FM%).
Measured: 0, 12, 16 and 28 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startMay 2009
- Primary completionJun 2010
- Study completionJun 2010
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 Low Risk for Cardiovascular DiseaseStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Ministry of industry, tourism and trade
- Responsible party
- Sponsor
- Investigators
- Carmen Gomez-Candela, MD, PhD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999088
- Sponsor's protocol ID
- HULP-2889
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bermejo LM, Lopez-Plaza B, Weber TK, Palma-Milla S, Iglesias C, Reglero G, Gomez-Candela C. Impact of cooked functional meat enriched with omega-3 fatty acids and rosemary extract on inflammatory and oxidative status; a randomised, double-blind, crossover study. Nutr Hosp. 2014 Nov 1;30(5):1084-91. doi: 10.3305/nh.2014.30.5.8048.
PubMed 25365012
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Cross-over Placebo-controlled Study to Assess the Functional Meat Products With n-3 and Rosemary Extract Fluid in Biochemical Markers of Cardiovascular Disease Related Risk in Subjects at Low Risk for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01999088
- Acronym / sponsor ID
- HULP-2889
- Conditions
- Low Risk for Cardiovascular Disease
- Keywords
- Fatty Acids, Omega-3, Rosemary extract, Functional meat, Cardiovascular disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Spanish Ministry of industry, tourism and trade
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Dec 2013 (estimated)
- 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.
Volunteers were randomly assigned by gender to follow of two 12 weeks experimental periods: intervention (I) and control (C) in different order (I/C or C/I). Both periods were separated by a 4 weeks wash-out interval during which subjects returned to their usual diet:
During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet.
During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).
Functional meat (FM) products (Functional cooked Ham (FH) and Functional cooked Turkey breast (FT)), were manufactured mixing the meats with the patented formula® (P200402755.2004). The amount of supercritical rosemary extract, deodorized salmon oil and vitamin E used was respectively, 0.02% w/w, 0.6% w/w, and 0.001% w/w.
Control meat (CM) products (Control cooked Ham (CH) and Control cooked Turkey (CT), were prepared without addition of the functional ingredients.
Detailed description
The total duration of the study was 28 weeks: first experimental period 0-12 weeks, washout period 12-16 weeks second experimental period 16-28 weeks:
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional meat | Experimental | Other: Functional Meet, Other: Control MeatDuring the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet. |
| Control Meat | Placebo comparator | Other: Functional Meet, Other: Control MeatDuring the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged over 18 years
- At least 2 lipid profile parameters altered (TAG ≥150 mg /dl and/or total cholesterol ≥200 mg / dl and/or LDL ≥130 mg / dl and/or HDL ≥40mg/dl men or ≥ 50mg/dl women).
- Signed informed consent
Key exclusion criteria (12 listed)
- Individuals with body mass index (BMI) ≥ 35 kg/m2
- Individuals with Diabetes Mellitus insulin dependent
- Individuals with disorders associated with eating behaviour
- Individuals with consumption of omega 3 functional foods, fish oil or antioxidant supplements
- Individuals inability to consume the test foods (ej. Vegetarians)
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 |
|---|---|---|
| Functional MeetAlso: Functional foodDuring the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet. | Other | Control Meat, Functional meat |
| Control MeatAlso: Control FoodDuring the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)). | Other | Control Meat, Functional meat |
Primary outcome
Lipid profile changes
Time frame: 0, 12, 16 and 28 week
Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Apolipoprotein B and Apolipoprotein A.
6 secondary outcomes
Framingham score changes
Time frame: 0, 12, 16 and 28 week
Inflammatory markers changes
Time frame: 0, 12, 16 and 28 week
Oxidative Stress Parameters changes
Time frame: 0, 12, 16 and 28 week
Glucosa Metabolism changes
Time frame: 0, 12, 16 and 28 week
Blood pressure and heart rate changes
Time frame: 0, 12, 16 and 28 week
Anthropometric parameters changes
Time frame: 0, 12, 16 and 28 week
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 3 Dec 2013.
- Derived from this study: PubMed 25365012Bermejo LM, Lopez-Plaza B, Weber TK, Palma-Milla S, Iglesias C, Reglero G, Gomez-Candela C. Impact of cooked functional meat enriched with omega-3 fatty acids and rosemary extract on inflammatory and oxidative status; a randomised, double-blind, crossover study. Nutr Hosp. 2014 Nov 1;30(5):1084-91. doi: 10.3305/nh.2014.30.5.8048.
- Institute for Health Research IdiPAZLink provided by the sponsor.
Related trials for Low Risk for Cardiovascular Disease
Active, not recruiting
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
Aortic Valve Stenosis
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingPhase 1
Low-Dose TBI Plus CAR T-Cell Therapy for Relapsed/Refractory DLBCL and Multiple Myeloma
Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed or Refractory Multiple Myeloma (MM)
RecruitingPhase 3
Testing a New Treatment Strategy to Improve Secondary Stroke Prevention for Older Adults: The STROKE75+ Trial
Stroke, Ischemic
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.
Carmen Gomez-Candela, MD, PhD principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Functional Meet in people with Low Risk for Cardiovascular Disease, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 3 inclusion and 12 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 3 Dec 2013. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lipid profile changes (time frame: 0, 12, 16 and 28 week). 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 NCT01999088, 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 3 Dec 2013.