Evaluation of the Beneficial Health Effects of an Additive-free Meat Product in Healthy Subjects … (NCT06392893) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in seric lipid profile
Timeframe: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
2
Changes in serum levels of oxidative stress
Timeframe: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
3
Changes in serum levels of inflammation markers
Timeframe: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)
4
Changes in microbiota composition
Timeframe: At the beginning of the intervention (baseline) and after 5 weeks of product intake (final time)