Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392893
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2024-04-16
Brief Title:
Evaluation of the Beneficial Health Effects of an Additive-free Meat Product in Healthy Subjects HIPOCARNE
Sponsor:
Universidad de Murcia
Organization:
Universidad de Murcia
Study Overview
Official Title:
Evaluation of the Beneficial Health Effects of an Additive-free Meat Product in Healthy Subjects HIPOCARNE
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None