Effect of a Multi-ingredient on Visceral Adiposity and Non-alcoholic Fatty Liver Disease in Individuals With Abdominal Obesity (FATHIS)

Fundació Eurecat

Status: Completed

Conditions: Visceral Obesity; Non-Alcoholic Fatty Liver Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT05807204

FATHIS

Details and patient eligibility

About

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.

Full description

World Health Organization (WHO) defines obesity as an excess of fat accumulation in adipose tissues and in other metabolic organs, leading to serious health implications. Obesity is a rising issue whose prevalence has defined as a global pandemic or globesity (>30% world population) being responsible of millions of deaths annually. Also, obesity is related with several comorbidities such as non-alcoholic fatty liver disease (NAFLD), with a global prevalence of >25%. Thus, strategies to ameliorate obesity and NAFLD are critical to improve life expectancy and quality of life and to reduce the economic burden of both diseases.

Current therapies against obesity are mainly focused on weight loss, including lifestyle intervention, to modify eating behaviours and to promote physical activity. However, the compliance of patients with these therapies is small. In addition, there are some drugs to fight against these diseases. In obesity, these medical therapies are focused to decrease fat gastrointestinal absorption using lipase inhibitors with several side effects: faecal incontinence, abdominal cramping and raise in blood pressure. In NAFLD, medical therapies are designed to reduce insulin resistance, using pioglitazone and metformin. However, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) recommend avoiding pioglitazone use by its relationship with heart failure and cancer, and metformin provides just a modest improvement in NAFLD.

Thus, the finding of new and efficient therapeutic agents is highly desirable to combat these global diseases.

The main objective of this study is to evaluate the effect of daily intake of a specific combination of L-histidine, L-serine, L-carnosine and N-Acetylcysteine, in combination with dietary recommendations, on the amount of visceral fat in individuals with abdominal obesity.

The secondary objectives of this study are to evaluate the effect of daily intake of the multi-ingredient aforementioned in liver fat content and obesity related comorbidities.

Participants who fulfilled the inclusion and exclusion criteria will be randomly assigned to the intervention and control group.

During the study there will be 4 visits: a preselection visit (V0; day -7) and 3 study visits during the consumption of the treatments, which will take place on the first day of the study (V1; day 1 +/- 3 days; week 1), at 6 weeks of treatment (V2; day 44 +/- 3 day; week 6) and at 12 weeks of treatment (V3; day 90 +/- 3 days; week 12).

Enrollment: 20 patients

Sex: Male

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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 or psychiatric disorders.
• Being unable to follow study guidelines.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine

Experimental group

Description:

Participants will daily consume the multi-ingredient (L-Histidine, L-Serine, L-Carnosine and N-Acetylcysteine) for 12 weeks.

Treatment:

Dietary Supplement: Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine

Placebo

Placebo Comparator group

Description:

Participants will daily consume the placebo (maltodextrin) for 12 weeks.

Treatment:

Dietary Supplement: Placebo