InflammationNCT06392893
Evaluation of the Beneficial Health Effects of an Additive-free Meat Product in Healthy Subjects (HIPOCARNE)
A study testing Meat product without additives and allergens and Commercial meat product in people with Inflammation and Oxidative Stress, run by Universidad de Murcia at 1 site in Spain.
Trial summary
The purpose of this research is to test the hypothesis that the consumption of meat products without additives, in comparison with their analogues with additives, could be beneficial in terms of modifying health markers. A 5-week clinical trial with two parallel arms will be performed with two parallel arms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Oxidative Stress, Food Toxicity
- What is being tested?
- Meat product without additives and allergens and Commercial meat product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2023to 7 Jun 2023
- 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
- Subjects of both sexes (men or women) between 18 and 65 years of age
- Body mass index between 18.5 and 30 Kg / m^2.
Who cannot join
- Diabetes mellitus, chronic kidney disease, liver disease, infectious diseases or any type of cancer.
- Eating disorders, intestinal or similar problems.
- Subjects in treatment with medication for hypertension or hyperlipaemia.
- Subjects in treatment with antibiotics in the last 3 months.
- Subjects who have ingested pre- or probiotic supplements.
- Subjects who have ingested omega-3 or omega-6 supplements.
Show all 13Show fewer
- Patients undergoing major surgery in the last 3 months prior to the beginning of the study.
- Subjects who have donated blood in the last month prior to the beginning of the study.
- Subjects with alcohol abuse, or with excessive alcohol consumption.
- Vegetarian subjects.
- Pregnant women.
- Smokers.
- Participation in other clinical trials in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to test the hypothesis that the consumption of meat products without additives, in comparison with their analogues with additives, could be beneficial in terms of modifying health markers. A 5-week clinical trial with two parallel arms will be performed with two parallel arms. Changes in different serum biomarkers of lipid metabolism, glucose, oxidative stress and inflammation will be analysed. Biomarkers related to digestive health, such as short chain fatty acid (SCFA) production and impact on the gut microbiota, will also be evaluated. Finally, factors such as body mass index (BMI), body fat percentage and markers of exposure to additives will be measured.
Read the detailed description
One of the most discussed reasons for reducing meat consumption is its additive content. Additives are compounds added to food products to preserve their technological properties, to avoid contamination by microorganisms, regulate acidity, and even act as thickeners, emulsifiers, and stabilisers. However, there is some controversy over the actual health effects of additives in meat products, as their long-term effect has not been studied for many of them. On the other hand, not all additives have the same effect, as for antioxidants such as sodium citrate (E-331) and sodium erythorbate (E-316), as well as acidity regulators such and triphosphates (E-451) no side effects or significant toxicity have been reported on healthy individuals. However, other additives such as carrageenans (E-407) have been associated with intestinal inflammation and inflammatory bowel diseases by several animal studies. Negative effects have also been found for sodium nitrite (E-250), which can lead to the formation of carcinogenic N-nitrosamines.
Due to the rising concern about additives in meat products, it is of particular interest to identify the possible health effects of a processed meat product without additives and allergens. Therefore, the hypothesis of this study is that the production of additive-free meat products may be of interest to the consumers and may have a beneficial effect on their health.
To confirm this hypothesis, two meat products without additives or allergens were produced (cooked ham and cooked turkey breast), and a double-blind, randomised, controlled, unicentric trial with two parallel arms will be conducted.
Prior to the start of the intervention period (baseline time) anthropometric measurements and blood, faeces and urine samples will be taken. 58 participants will take alternately 100g of cooked ham or cooked turkey breast (control or reformulated depending on the group) 6 days a week for 5 weeks, noting the rest of their diet in a collection notebook that they will then give to the researchers. After the intervention (final time), anthropometric measurements and blood, faeces and urine samples will be taken again.
- Conditions
- Inflammation, Oxidative Stress, Food Toxicity
- Being tested
- Meat product without additives and allergens, Commercial meat product
- Keywords
- Additives, Allergens, Cooked ham, Cooked turkey breast, Inflammation, Oxidation, Nitrates, Gut microbiota
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meat product without additives and allergensCombination product
Baseline time: Measurement of anthropometric parameters and inflammatory and oxidative markers in blood, faeces and urine.
Consumption of meat products without additives and allergens (6 days a week; 5 weeks).
Final time: Measurement of anthropometric parameters and inflammatory and oxidative markers in blood, faeces and urine.
Commercial meat productCombination product
Baseline time: Measurement of anthropometric parameters and inflammatory and oxidative markers in blood, faeces and urine.
Consumption of commercial meat products (6 days a week; 5 weeks).
Final time: Measurement of anthropometric parameters and inflammatory and oxidative markers in blood, faeces and urine.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Consumption of an additive and allergen-free cooked ham or cooked turkey breast.
Quantity: 100 grams.
Consumption time: 6 days a week during 5 weeks. Receives: Combination Product: Meat product without additives and allergens |
| Control | Placebo comparator | Consumption of a commercial cooked ham or cooked turkey breast.
Quantity: 100 grams.
Consumption time: 6 days a week during 5 weeks. Receives: Combination Product: Commercial meat product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in seric lipid profile
Seric measurement of triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and total cholesterol.
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in serum levels of oxidative stress
Seric measurement of malondialdehyde (MDA), serum glutathione peroxidase (GPx), catalase (CAT), oxidized LDL, Ferric reducing ability of plasma (FRAP) and ABTS (2,2'-azino-bis(3-methylbenzothiazole-6-sulfonic acid).
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in serum levels of inflammation markers
Seric measurement of C-reactive protein (CRP), Tumor necrosis factor α (TNF-α), Interleukin 1β (IL-1β), Interleukin 6 (IL-6) and Interleukin 10 (IL-10).
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in microbiota composition
Measurement of changes in the abundance of the different bacteria present in the gut.
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Secondary outcomes (9)
Serum levels of glucose
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Serum levels of Alanine Transaminase (ALT) and Aspartate Aminotransferase (AST)
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in the concentration of nitrates in urine
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in faecal levels of oxidative stress
Measurement of FRAP levels in faeces.
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in urine levels of oxidative stress
Measurement of FRAP levels in urine.
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in the concentration of short chain fatty acids in faeces.
Measurement of acetate, propionate, butyrate and total SCFA in faeces.
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in body mass Index (BMI)
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in hip-to-waist ratio
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in body fat mass percentage
Measured: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start15 Apr 2023
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomised, controlled, unicentric trial with two parallel arms depending on the product consumed
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392893
- Sponsor's protocol ID
- Hipocarne UMU 550/2023
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Beneficial Health Effects of an Additive-free Meat Product in Healthy Subjects (HIPOCARNE)
- ClinicalTrials.gov ID
- NCT06392893
- Acronym / sponsor ID
- Hipocarne UMU 550/2023
- Conditions
- Inflammation, Oxidative Stress, Food Toxicity
- Keywords
- Additives, Allergens, Cooked ham, Cooked turkey breast, Inflammation, Oxidation, Nitrates, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 1 May 2024 (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 purpose of this research is to test the hypothesis that the consumption of meat products without additives, in comparison with their analogues with additives, could be beneficial in terms of modifying health markers. A 5-week clinical trial with two parallel arms will be performed with two parallel arms. Changes in different serum biomarkers of lipid metabolism, glucose, oxidative stress and inflammation will be analysed. Biomarkers related to digestive health, such as short chain fatty acid (SCFA) production and impact on the gut microbiota, will also be evaluated. Finally, factors such as body mass index (BMI), body fat percentage and markers of exposure to additives will be measured.
Detailed description
One of the most discussed reasons for reducing meat consumption is its additive content. Additives are compounds added to food products to preserve their technological properties, to avoid contamination by microorganisms, regulate acidity, and even act as thickeners, emulsifiers, and stabilisers. However, there is some controversy over the actual health effects of additives in meat products, as their long-term effect has not been studied for many of them. On the other hand, not all additives have the same effect, as for antioxidants such as sodium citrate (E-331) and sodium erythorbate (E-316), as well as acidity regulators such and triphosphates (E-451) no side effects or significant toxicity have been reported on healthy individuals. However, other additives such as carrageenans (E-407) have been associated with intestinal inflammation and inflammatory bowel diseases by several animal studies. Negative effects have also been found for sodium nitrite (E-250), which can lead to the formation of carcinogenic N-nitrosamines.
Due to the rising concern about additives in meat products, it is of particular interest to identify the possible health effects of a processed meat product without additives and allergens. Therefore, the hypothesis of this study is that the production of additive-free meat products may be of interest to the consumers and may have a beneficial effect on their health.
To confirm this hypothesis, two meat products without additives or allergens were produced (cooked ham and cooked turkey breast), and a double-blind, randomised, controlled, unicentric trial with two parallel arms will be conducted.
Prior to the start of the intervention period (baseline time) anthropometric measurements and blood, faeces and urine samples will be taken. 58 participants will take alternately 100g of cooked ham or cooked turkey breast (control or reformulated depending on the group) 6 days a week for 5 weeks, noting the rest of their diet in a collection notebook that they will then give to the researchers. After the intervention (final time), anthropometric measurements and blood, faeces and urine samples will be taken again.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomised, controlled, unicentric trial with two parallel arms depending on the product consumed
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Meat product without additives and allergensConsumption of an additive and allergen-free cooked ham or cooked turkey breast. Quantity: 100 grams. Consumption time: 6 days a week during 5 weeks. |
| Control | Placebo comparator | Combination Product: Commercial meat productConsumption of a commercial cooked ham or cooked turkey breast. Quantity: 100 grams. Consumption time: 6 days a week during 5 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects of both sexes (men or women) between 18 and 65 years of age
- Body mass index between 18.5 and 30 Kg / m^2.
Key exclusion criteria (13 listed)
- Diabetes mellitus, chronic kidney disease, liver disease, infectious diseases or any type of cancer.
- Eating disorders, intestinal or similar problems.
- Subjects in treatment with medication for hypertension or hyperlipaemia.
- Subjects in treatment with antibiotics in the last 3 months.
- Subjects who have ingested pre- or probiotic supplements.
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 |
|---|---|---|
| Meat product without additives and allergensBaseline time: Measurement of anthropometric parameters and inflammatory and oxidative markers in blood, faeces and urine. Consumption of meat products without additives and allergens (6 days a week; 5 weeks). Final time: Measurement of anthropometric parameters and inflammatory and oxidative markers in blood, faeces and urine. | Combination product | Intervention |
| Commercial meat productBaseline time: Measurement of anthropometric parameters and inflammatory and oxidative markers in blood, faeces and urine. Consumption of commercial meat products (6 days a week; 5 weeks). Final time: Measurement of anthropometric parameters and inflammatory and oxidative markers in blood, faeces and urine. | Combination product | Control |
Primary outcome
Changes in seric lipid profile
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Seric measurement of triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and total cholesterol.
Changes in serum levels of oxidative stress
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Seric measurement of malondialdehyde (MDA), serum glutathione peroxidase (GPx), catalase (CAT), oxidized LDL, Ferric reducing ability of plasma (FRAP) and ABTS (2,2'-azino-bis(3-methylbenzothiazole-6-sulfonic acid).
Changes in serum levels of inflammation markers
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Seric measurement of C-reactive protein (CRP), Tumor necrosis factor α (TNF-α), Interleukin 1β (IL-1β), Interleukin 6 (IL-6) and Interleukin 10 (IL-10).
Changes in microbiota composition
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Measurement of changes in the abundance of the different bacteria present in the gut.
9 secondary outcomes
Serum levels of glucose
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Serum levels of Alanine Transaminase (ALT) and Aspartate Aminotransferase (AST)
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in the concentration of nitrates in urine
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in faecal levels of oxidative stress
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in urine levels of oxidative stress
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in the concentration of short chain fatty acids in faeces.
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in body mass Index (BMI)
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in hip-to-waist ratio
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
Changes in body fat mass percentage
Time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
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 1 May 2024.
- 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.
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 Meat product without additives and allergens and Commercial meat product in people with Inflammation and Oxidative Stress, run by Universidad de Murcia 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 2 inclusion and 13 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 1 May 2024. 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 seric lipid profile (time frame: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2024.