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

NCT05807204 | Completed

• 1 other identifier: FATHIS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Visceral Obesity; Non-Alcoholic Fatty Liver Disease

Keywords

Nutraceuticals; Visceral Obesity; NAFLD; Metabolic risk; L-histidine; L-serine; N-Acetylcysteine; L-carnosine; Glucose metabolism; Lipid metabolism; Hepatic steatosis; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Visceral Adiposity

  Visceral fat content measured using a dual energy x-ray absorptiometry (DXA) scanner

  Change from Baseline Visceral Adiposity at 12 weeks for each of the two treatments (multi-ingredient and placebo)

Secondary Outcomes (44)

• Change in Hepatic Steatosis

  Change from Baseline Hepatic Steatosis at 12 weeks for each of the two treatments (multi-ingredient and placebo)

• Height (cm)

  At Baseline

• Change in Weight (kg)

  Change from Baseline Weight at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)

• Change in Body Mass Index (BMI) (Kg/m^2)

  Change from Baseline Body Mass Index at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)

• Change in Neck circumference (cm)

  Change from Baseline Neck circumference at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)

Study Arms (2)

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

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

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

The product will be presented in powder format in a single container and with a measuring spoon of the daily dose.

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

Placebo DIETARY_SUPPLEMENT

The product will be presented in powder format in a single container and with a measuring spoon of the daily dose.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
• Suffering from eating behavior disorders or psychiatric disorders.

Sponsors & Collaborators

• Fundació Eurecat: lead
• Centre de Diagnosi per la Imatge: collaborator
• Laboratorio de Referencia Sud: collaborator
• Centro OWLiver: collaborator

Study Sites (1)

Eurecat

Reus, 43204, Spain

Location

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus

MeSH Terms

Conditions

Obesity, Abdominal; Non-alcoholic Fatty Liver Disease; Fatty Liver; Hypertension

Interventions

Serine; Carnosine; Acetylcysteine

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Neuropeptides; Peptides; Dipeptides; Oligopeptides; Nerve Tissue Proteins; Proteins; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals

Study Officials

• Xavier Escoté, PhD

  Eurecat, Technology Centre of Catalonia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 11, 2023
• Study Start: May 1, 2023
• Primary Completion: December 20, 2023
• Study Completion: January 11, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)