CompletedNot Applicable

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

Spain58 participantsStarted 2023-04-15

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Changes in seric lipid profile

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

Changes in serum levels of oxidative stress

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

Changes in serum levels of inflammation markers

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

Changes in microbiota composition

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

Trial details

NCT IDNCT06392893

SponsorUniversidad de Murcia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-07

View on ClinicalTrials.gov More Inflammation trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in seric lipid profile

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

Changes in serum levels of oxidative stress

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

Changes in serum levels of inflammation markers

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

Changes in microbiota composition

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