NCT05807204Completed
Effect of a Multi-ingredient on Visceral Adiposity and Non-alcoholic Fatty Liver Disease in Individuals With Abdominal Obesity
Effect of a Multi-ingredient of L-Histidine, L-Serine, L-Carnosine and N-Acetylcysteine on Visceral Adiposity and Non-alcoholic Fatty Liver Disease in Individuals With Abdominal Obesity. Randomized, Parallel, Placebo Controlled, Triple Blind Study.
Source: ClinicalTrials.gov · Last updated 23 Feb 2024
Brief summary (registry, in English)
The aim of this study is to validate the efficacy of specific combination of different natural histidine-related amino acids in the reduction of visceral fat and liver steatosis, as well their associated comorbidities, in individuals with abdominal obesity.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 15 Mar 2023
- Start date
- 1 May 2023
- Primary completion date
- 20 Dec 2023
- Lead sponsor
- Fundació Eurecat
- NCT number
- NCT05807204
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 May 2023 to the primary completion date, 20 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Follow a pharmacological treatment with immunosuppressants, cytotoxic agents, corticosteroids or other drugs that could cause hepatic steatosis or alter the measurements in the liver.
- Being participating or having participated in a clinical trial or nutritional intervention study in the last 30 days before inclusion in the study.
Other illness
- Present diabetes.
- Present any diagnosed liver disease other than NAFLD.
- Present food intolerances and/or allergies related to the study products, such as hypersensitivity to maltodextrin or N-Acetylcysteine.
- Presenting any chronic or autoimmune disease in clinical manifestation such as hepatitis, hyper or hypothyroidism or metabolic diseases.
- Suffering from eating behavior disorders or psychiatric disorders.
Lab values
- Present dyslipidemia (LDL cholesterol ≥ 189 mg/dL and/or triglycerides ≥ 350 mg/dL).
Other
- Present values of body mass index \> 35 kg/m\^2
- Present values of waist circumference \> 150 cm.
- Present anemia.
- Taking supplements, multivitamin supplements or phytotherapeutic products that interfere with the treatment under study.
- Consume 4 or more Standard Beverage Units (SBU) daily or 28 SBU weekly.
- Be a smoker.
- Have lost more than 3 kg of weight in the last 3 months.
- Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
- Being unable to follow study guidelines.
Who the study is looking for
- Men older than 40 years.
- BMI ≥30.0 kg/m\^2 and ≤35.0 kg/m\^2
- Waist circumference ≥102 cm.
- Read, write and speak Catalan or Spanish.
- Sign the informed consent.
Age in the registry: 40 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eurecat Coordinator of this site? Confirm its status | Reus | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.