Healthy VolunteersNCT02813031
Human Study of Functional Meat Products
A study testing Functional meat products and Traditional meat products in people with Healthy Volunteers, run by IMDEA Food at 1 site in Spain.
Trial summary
Nutritional clinical trial to evaluate the effectiveness of different functional meat products on the nutritional status of healthy people Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Functional meat products and Traditional meat products
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2015to Jun 2015
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 18 - 65 years old.
- BMI >20<27
- Adequate education level and comprehension of the clinical study.
- Willingness to participate in the study as a volunteer and to provide written consent.
Who cannot join
- Diagnosis of Type I Diabetes .
- BMI >27
- Dyslipidemia under pharmacological treatment.
- High blood pressure.
- Dementia, neurological disease or reduction of cognitive function.
- Severe illness (hepatic disease, renal disease, etc.).
Show all 14Show fewer
- Refusal to consume the experimental or control meat products (e.g. Vegetarians)
- Refusal to follow healthy eating guidelines.
- Taking medications that could affect the lipid and glycemic profiles (statins, fibrate, diuretics, corticoids, anti-inflammatory, hypoglucemic or insulin) 30 days before the beginning of the study.
- Taking medications or substances for weight loss management (15 days before the beginning of the study).
- Consideration to follow a weight loss diet during the duration of the study.
- Pregnancy or lactation.
- High intake of alcohol.
- Any other exclusion criteria that the main investigator considers relevant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Intervention Study to Evaluate the Effect of an Olive Oil Lipid Rich in Diglycerides as a Fat Replacement in Different Meat Products, in a Healthy Population
Nutritional clinical trial to evaluate the effectiveness of different functional meat products on the nutritional status of healthy people
Read the detailed description
Different studies have revealed that many chronic pathologies including cardiovascular disease, diabetes, autoimmune disorders, cancer, obesity or neurological diseases, could be influenced by different dietary components, such as lipids. Thus, looking for ways to substitute healthier lipids for fats that contain high amounts of cholesterol, saturated fatty acids or trans fat, could be of great interest in the prevention of chronic diseases.
Currently, meat and meat products, especially those where the fat is one of the main ingredients of the formulation, are perceived as unhealthy foods associated with increased risk of cardiovascular disease, cancer and obesity development. This is mainly due to their content of fat, trans fat, high percentage of saturated fatty acids, and cholesterol. Examples include sausages, meat spreads, salami or mortadella. Interestingly, despite the negative perception, meat and meat products continue to hold a relevant position in the diet of the developed countries. Indeed, the group "meat, poultry, deli meats and offal" contribute to the 17% of the total dietary fat intake of the Spanish population. Moreover, the consumption of deli meats and other meat products represents 5.8% of the total caloric intake. These values support the increased interest in evaluating the effect of improving the composition of these products in the prevention of disease.
Overweight and obesity are main public health concerns worldwide. They both contribute to the development of numerous diseases increasing the morbidity and mortality rates of the adult population. In this context, it is suggested that the incorporation of healthier fats may be of great interest in the prevention of these conditions. Thus, usage of lipids from olive oil as fats replacements in meat products could be an interesting strategy for the prevention and treatment of overweight and obesity.
A randomized, controlled, nutritional intervention is proposed to evaluate the effect of functional meat products on body composition and lipid profile in healthy individuals.
- Conditions
- Healthy Volunteers
- Being tested
- Functional meat products, Traditional meat products
- Keywords
- functional meat products, hypocaloric fats, diglyceride, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional meat productsOther
Traditional meat productsOther
| Study group | Role | What they receive |
|---|---|---|
| Functional meat products with healthy lipids from olive oil | Experimental | Healthy people consuming 300g/week of functional meat products with high diglyceride lipid from olive oil Receives: Other: Functional meat products |
| Traditional meat products | Placebo comparator | Healthy people consuming the same amount of traditional meat products Receives: Other: Traditional meat products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in waist circumference
The waist circumference (WC) was measured using a Seca 201 inelastic tape (Quirumed, Valencia, Spain).
Measured: Before and after 8 weeks
Secondary outcomes (4)
Changes in lipid profile
To evaluate lipid improvements the following measurements will be taking into account:
- Triglycerides
- Total Cholesterol
- Low Density Lipoprotein
- Very Low Density Lipoprotein
- High Density Lipoprotein
- Apolipoprotein B100 Apolipoprotein E
- Free fatty acids
Measured: Before and after 8 weeks
Changes in fat depots
To evaluate changes in fat depots leptin levels will be measured
Measured: Before and after 8 weeks
Changes in blood clotting and endothelial function
To evaluate changes in blood clotting and endothelial function will be taken into account:
- PAI I
- Fibrinogen
Measured: Before and after 8 weeks
Product safety
To con trol the safety of the products the following variables will be measured:
- Urea
- Creatinine
- GOT
- GPT
Measured: Before and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMDEA Food
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viviana Loria Kohen, IMDEA Food
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813031
- Sponsor's protocol ID
- IMD PI014
- Status last verified
- Jun 2016
- First submitted
- 17 Jun 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
Publications
Nagao T, Watanabe H, Goto N, Onizawa K, Taguchi H, Matsuo N, Yasukawa T, Tsushima R, Shimasaki H, Itakura H. Dietary diacylglycerol suppresses accumulation of body fat compared to triacylglycerol in men in a double-blind controlled trial. J Nutr. 2000 Apr;130(4):792-7. doi: 10.1093/jn/130.4.792.
PubMed 10736331Pearson AM. (1997). Principles and applications in production of reduced and low fat products. In: Production and processing of healthy meat, poultry and fish products. Advances in meat research. Vol 11. Pearson AM, Dutson TR (Eds). Blackie Academic & Professional
Rudkowska I, Roynette CE, Demonty I, Vanstone CA, Jew S, Jones PJ. Diacylglycerol: efficacy and mechanism of action of an anti-obesity agent. Obes Res. 2005 Nov;13(11):1864-76. doi: 10.1038/oby.2005.229.
PubMed 16339116Saito S, Yamaguchi T, Shoji K, Hibi M, Sugita T, Takase H. Effect of low concentration of diacylglycerol on mildly postprandial hypertriglyceridemia. Atherosclerosis. 2010 Dec;213(2):539-44. doi: 10.1016/j.atherosclerosis.2010.07.062. Epub 2010 Aug 19.
PubMed 20837352
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention Study to Evaluate the Effect of an Olive Oil Lipid Rich in Diglycerides as a Fat Replacement in Different Meat Products, in a Healthy Population
- ClinicalTrials.gov ID
- NCT02813031
- Acronym / sponsor ID
- IMD PI014
- Conditions
- Healthy Volunteers
- Keywords
- functional meat products, hypocaloric fats, diglyceride, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- IMDEA FoodUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Jun 2016 (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.
Nutritional clinical trial to evaluate the effectiveness of different functional meat products on the nutritional status of healthy people
Detailed description
Different studies have revealed that many chronic pathologies including cardiovascular disease, diabetes, autoimmune disorders, cancer, obesity or neurological diseases, could be influenced by different dietary components, such as lipids. Thus, looking for ways to substitute healthier lipids for fats that contain high amounts of cholesterol, saturated fatty acids or trans fat, could be of great interest in the prevention of chronic diseases.
Currently, meat and meat products, especially those where the fat is one of the main ingredients of the formulation, are perceived as unhealthy foods associated with increased risk of cardiovascular disease, cancer and obesity development. This is mainly due to their content of fat, trans fat, high percentage of saturated fatty acids, and cholesterol. Examples include sausages, meat spreads, salami or mortadella. Interestingly, despite the negative perception, meat and meat products continue to hold a relevant position in the diet of the developed countries. Indeed, the group "meat, poultry, deli meats and offal" contribute to the 17% of the total dietary fat intake of the Spanish population. Moreover, the consumption of deli meats and other meat products represents 5.8% of the total caloric intake. These values support the increased interest in evaluating the effect of improving the composition of these products in the prevention of disease.
Overweight and obesity are main public health concerns worldwide. They both contribute to the development of numerous diseases increasing the morbidity and mortality rates of the adult population. In this context, it is suggested that the incorporation of healthier fats may be of great interest in the prevention of these conditions. Thus, usage of lipids from olive oil as fats replacements in meat products could be an interesting strategy for the prevention and treatment of overweight and obesity.
A randomized, controlled, nutritional intervention is proposed to evaluate the effect of functional meat products on body composition and lipid profile in healthy individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional meat products with healthy lipids from olive oil | Experimental | Other: Functional meat productsHealthy people consuming 300g/week of functional meat products with high diglyceride lipid from olive oil |
| Traditional meat products | Placebo comparator | Other: Traditional meat productsHealthy people consuming the same amount of traditional meat products |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women between 18 - 65 years old.
- BMI >20<27
- Adequate education level and comprehension of the clinical study.
- Willingness to participate in the study as a volunteer and to provide written consent.
Key exclusion criteria (14 listed)
- Diagnosis of Type I Diabetes .
- BMI >27
- Dyslipidemia under pharmacological treatment.
- High blood pressure.
- Dementia, neurological disease or reduction of cognitive function.
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 meat products | Other | Functional meat products with healthy lipids from olive oil |
| Traditional meat products | Other | Traditional meat products |
Primary outcome
Changes in waist circumference
Time frame: Before and after 8 weeks
The waist circumference (WC) was measured using a Seca 201 inelastic tape (Quirumed, Valencia, Spain).
4 secondary outcomes
Changes in lipid profile
Time frame: Before and after 8 weeks
Changes in fat depots
Time frame: Before and after 8 weeks
Changes in blood clotting and endothelial function
Time frame: Before and after 8 weeks
Product safety
Time frame: Before and after 8 weeks
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 24 Jun 2016.
- Background: PubMed 10736331Nagao T, Watanabe H, Goto N, Onizawa K, Taguchi H, Matsuo N, Yasukawa T, Tsushima R, Shimasaki H, Itakura H. Dietary diacylglycerol suppresses accumulation of body fat compared to triacylglycerol in men in a double-blind controlled trial. J Nutr. 2000 Apr;130(4):792-7. doi: 10.1093/jn/130.4.792.
- BackgroundPearson AM. (1997). Principles and applications in production of reduced and low fat products. In: Production and processing of healthy meat, poultry and fish products. Advances in meat research. Vol 11. Pearson AM, Dutson TR (Eds). Blackie Academic & Professional
- Background: PubMed 16339116Rudkowska I, Roynette CE, Demonty I, Vanstone CA, Jew S, Jones PJ. Diacylglycerol: efficacy and mechanism of action of an anti-obesity agent. Obes Res. 2005 Nov;13(11):1864-76. doi: 10.1038/oby.2005.229.
- Background: PubMed 20837352Saito S, Yamaguchi T, Shoji K, Hibi M, Sugita T, Takase H. Effect of low concentration of diacylglycerol on mildly postprandial hypertriglyceridemia. Atherosclerosis. 2010 Dec;213(2):539-44. doi: 10.1016/j.atherosclerosis.2010.07.062. Epub 2010 Aug 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional meat products and Traditional meat products in people with Healthy Volunteers, run by IMDEA Food 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 4 inclusion and 14 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 24 Jun 2016. 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.
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?
Changes in waist circumference (time frame: Before and after 8 weeks). 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 NCT02813031, which also lists 4 linked publications.
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 24 Jun 2016; AzTrials last refreshed its copy on 31 Oct 2026.