Effect of a Multi-ingredient on Visceral Adiposity and Non-alcoholic Fatty Liver Disease in Indiv… (NCT05807204) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Multi-ingredient on Visceral Adiposity and Non-alcoholic Fatty Liver Disease in Individuals With Abdominal Obesity
Spain20 participantsStarted 2023-05-01
Plain-language summary
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.
Who can participate
Age range40 Years
SexMALE
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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:
* 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.
Exclusion Criteria:
* Present values of body mass index \> 35 kg/m\^2
* Present values of waist circumference \> 150 cm.
* Present diabetes.
* Present dyslipidemia (LDL cholesterol ≥ 189 mg/dL and/or triglycerides ≥ 350 mg/dL).
* 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.
* Present any diagnosed liver disease other than NAFLD.
* Have lost more than 3 kg of weight in the last 3 months.
* 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.
* 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.
* Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
* Suffering from eating behavior disorders o…
What they're measuring
1
Change in Visceral Adiposity
Timeframe: Change from Baseline Visceral Adiposity at 12 weeks for each of the two treatments (multi-ingredient and placebo)