Effect of Multi-ingredient on Visceral Adiposity & Non-alcoholic Fatty Liver Disease in Postmenopausal Women With Abdominal Obesity (FATHIS+)

Fundació Eurecat

Status: Completed

Conditions: Visceral Obesity; Postmenopausal; Non-alcoholic Fatty Liver

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06377631

FATHIS+

Details and patient eligibility

About

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.

Full description

In postmenopausal women, the risk of non-alcoholic fatty liver disease (NAFLD) increases due to hormonal changes and metabolic shifts. Menopause leads to a decline in estrogen levels, affecting lipid metabolism and promoting abdominal and visceral fat accumulation. This visceral adiposity poses a significant risk factor for insulin resistance, type 2 diabetes, dyslipidemia, cardiovascular diseases, and NAFLD. While the prevalence of NAFLD is initially higher in men, it becomes comparable or even higher in postmenopausal women due to these metabolic changes.

Studies suggest that estrogen deficiency post-menopause contributes to the development of NAFLD in women. Lower serum estrogen levels are associated with a higher likelihood of NAFLD development, indicating the potential role of hormone replacement therapy (HRT) in mitigating NAFLD risk in postmenopausal women. However, the use of HRT must be carefully evaluated due to potential adverse effects on cardiovascular health.

Thus, novel, effective and safety therapeutic strategies for managing metabolic disorders in postmenopausal women are highly desirable.

The main objective of this study is 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 in postmenopausal women with abdominal obesity.

The secondary objectives of this study are to evaluate the effect of daily intake of the multi-ingredient aforementioned in liver function markers, anthropometric parameters, blood pressure and heart rate, markers of lipid metabolism, markers of glucidic metabolism, inflammatory markers, histidine serum levels, sexual hormones, the temperature of supraclavicular brown adipose tissue, changes in the intestinal microbiota, changes in the expression of lipid metabolism-related genes and symptoms associated with postmenopause.

A randomized, parallel, placebo-controlled, single-center, triple-blind clinical trial with a 1:1:1 ratio between interventions with 50 participants will be conducted.

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 43 +/- 3 day; week 6) and at 12 weeks of treatment (V3; day 85 +/- 3 days; week 12).

Enrollment: 50 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 diabetes.
• 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.
• 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

---

50 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