Evaluation of the Beneficial Health Effects of an Additive-free Meat Product in Healthy Subjects (HIPOCARNE)

NCT06392893 | Completed

• 1 other identifier: Hipocarne UMU 550/2023
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Oxidative Stress; Food Toxicity

Keywords

Additives; Allergens; Cooked ham; Cooked turkey breast; Inflammation; Oxidation; Nitrates; Gut microbiota

Outcome Measures

Primary Outcomes (4)

• Changes in seric lipid profile

  Seric measurement of triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and total cholesterol.

  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).

  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).

  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.

  At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)

Secondary Outcomes (9)

• Serum levels of glucose

  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)

  At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)

• Changes in the concentration of nitrates in urine

  At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)

• Changes in faecal levels of oxidative stress

  At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)

• Changes in urine levels of oxidative stress

  At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)

Study Arms (2)

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.

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.

Combination Product: Commercial meat product

Interventions

Meat product without additives and allergens COMBINATION_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.

Intervention

Commercial meat product COMBINATION_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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Edificio Pleyades-Vitalys

Murcia, 30100, Spain

Location

MeSH Terms

Conditions

Inflammation

Interventions

Meat Products; Allergens

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, randomised, controlled, unicentric trial with two parallel arms depending on the product consumed

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 1, 2024
• Study Start: April 15, 2023
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)