NCT06377631Completed
Effect of Multi-ingredient on Visceral Adiposity & Non-alcoholic Fatty Liver Disease in Postmenopausal Women 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 Postmenopausal Women With Abdominal Obesity
Source: ClinicalTrials.gov · Last updated 17 Apr 2025
Brief summary (registry, in English)
This study aims to evaluate the effect of daily intake of a specific combination of different natural histidine-related amino acids in combination with dietary recommendations, in the reduction of visceral fat, as well as their associated comorbidities, in postmenopausal women with abdominal obesity.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 17 Apr 2024
- Start date
- 7 Jun 2024
- Primary completion date
- 8 Apr 2025
- Lead sponsor
- Fundació Eurecat
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06377631
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 7 Jun 2024 to the primary completion date, 8 Apr 2025
- 2 sites 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.
Other
- Present values of body mass index \< 27.5 kg/m\^2 or \> 32.5 kg/m\^2
- Present values of waist circumference \> 115 cm.
- Present dyslipidemia.
- Present anemia.
- Taking supplements, multivitamin supplements or phytotherapeutic products that interfere with the treatment under study.
- Consume 2 or more Standard Beverage Units (SBU) daily or 17 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
- Postmenopausal women aged 50 to 65 years.
- BMI ≥27.5 kg/m\^2 and ≤32.5 kg/m\^2.
- Waist circumference ≥88 cm.
- No hormone replacement therapy.
- Read, write and speak Catalan or Spanish.
- Sign the informed consent.
Age in the registry: 50 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anna Crescenti Coordinator of this site? Confirm its status | Reus | Spain | Unknown status |
| Fundació 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.