Visceral ObesityFATHISNCT05807204
Effect of a Multi-ingredient on Visceral Adiposity and Non-alcoholic Fatty Liver Disease in Individuals With Abdominal Obesity
A study testing Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine in people with Visceral Obesity and Non-Alcoholic Fatty Liver Disease, run by Fundació Eurecat at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Visceral Obesity, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2023to 11 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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 Individuals With Abdominal Obesity. Randomized, Parallel, Placebo Controlled, Triple Blind Study.
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.
Read the detailed 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).
- Being tested
- Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine, Placebo
- Keywords
- Nutraceuticals, Visceral Obesity, NAFLD, Metabolic risk, L-histidine, L-serine, N-Acetylcysteine, L-carnosine, Glucose metabolism, Lipid metabolism, Hepatic steatosis, Hypertension
- Medical subject headings
- Obesity, Abdominal, Non-alcoholic Fatty Liver Disease, Fatty Liver, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-ingredient of L-histidine, L-serine, L-carnosine and N-AcetylcysteineDietary supplement
The product will be presented in powder format in a single container and with a measuring spoon of the daily dose.
PlaceboDietary supplement
The product will be presented in powder format in a single container and with a measuring spoon of the daily dose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visceral Adiposity
Visceral fat content measured using a dual energy x-ray absorptiometry (DXA) scanner
Measured: 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
Liver steatosis will be qualitative determined by ultrasound
Measured: Change from Baseline Hepatic Steatosis at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Height (cm)
Height measured with standardized method
Measured: At Baseline
Change in Weight (kg)
Weight measured with standardized method
Measured: 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)
Weight and height will be combined to report BMI in kg/m^2
Measured: 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)
Neck circumference using a measuring tape
Measured: Change from Baseline Neck circumference at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Arm circumference (cm)
Arm circumference using a measuring tape
Measured: Change from Baseline Arm circumference at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Waist circumference (cm)
Waist circumference using a measuring tape
Measured: Change from Baseline Waist circumference at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Conicity Index
Weight, height and waist circumference will be combined to report Conicity index.
Measured: Change from Baseline Conicity Index at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Systolic Blood Pressure (mm Hg)
Systolic blood pressure will be measured using an automatic sphygmomanometer
Measured: Change from Baseline Systolic Blood Pressure at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Diastolic Blood Pressure (mm Hg)
Diastolic blood pressure will be measured using an automatic sphygmomanometer
Measured: Change from Baseline Systolic Blood Pressure at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in intestinal microbiota composition
Metagenomic analysis in fecal samples. The bacteria DNA will be extracted and massive sequenced by the Ion Torrent platform.
Measured: Change from Baseline intestinal microbiota composition at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change of biomarkers of oxidative stress (8-OHdG, F2-isoprostanes)
Biomarkers of oxidative stress will be evaluated in urine by standardized chemiluminescence methods
Measured: Change from Baseline biomarkers of oxidative stress at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum glucose levels (mg/dL)
Serum glucose levels will be determined by standardized spectrophotometry methods
Measured: Change from Baseline serum glucose levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum total cholesterol (mg/dL)
Total cholesterol will be determined by standardized spectrophotometry methods
Measured: Change from Baseline serum total cholesterol at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum high-density lipoprotein cholesterol (HDL-C,mg/dL)
High-density lipoprotein cholesterol will be determined by standardized spectrophotometry methods
Measured: Change from Baseline serum high-density lipoprotein cholesterol at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum low-density lipoprotein cholesterol (LDL-C, mg/dL)
Low-density lipoprotein cholesterol will be calculated using the Friedewald formula
Measured: Change from Baseline serum low-density lipoprotein cholesterol at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum triglycerides (TG, mg/dL)
Triglycerides will be determined by standardized spectrophotometry methods
Measured: Change from Baseline serum triglycerides at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum alanine aminotransferase (ALT, U/L)
Alanine aminotransferase will be determined by standardized spectrophotometry methods
Measured: Change from Baseline serum alanine aminotransferase at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum aspartate aminotransferase (AST, U/L)
Aspartate aminotransferase will be determined by standardized spectrophotometry methods
Measured: Change from Baseline serum aspartate aminotransferase at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum gamma glutamyl transferase (GGT, U/L)
Gamma glutamyl transferase will be determined by standardized spectrophotometry methods
Measured: Change from Baseline serum gamma glutamyl transferase at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum insulin levels (mU/L)
Insulin levels will be measured by standardized chemiluminescence methods.
Measured: Change from Baseline serum insulin levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum leptin levels (pg/mL)
Leptin levels will be measured by standardized chemiluminescence methods
Measured: Change from Baseline serum leptin levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum adiponectin levels (ng/mL)
Adiponectin levels will be measured by standardized chemiluminescence methods
Measured: Change from Baseline serum adiponectin levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Adiponectin/Leptin ratio (numerical ratio)
Adiponectin and leptin will be combined to report adiponectin/leptin ratio
Measured: Change from Baseline Adiponectin/Leptin ratio at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum Monocyte chemoattractant protein-1 (MCP-1) levels (pg/mL)
MCP-1 levels will be measured by standardized chemiluminescence methods
Measured: Change from Baseline serum MCP-1 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma tumor necrosis factor alpha (TNF-alpha) levels (pg/mL)
TNF-alpha levels will be measured by standardized chemiluminescence methods
Measured: Change from Baseline plasma TNF-alpha levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma Interleukin 6 (IL-6) levels (pg/mL)
IL-6 levels will be measured by standardized chemiluminescence methods
Measured: Change from Baseline plasma IL-6 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma Interleukin 10 (IL-10) levels (pg/mL)
IL-10 levels will be measured by standardized chemiluminescence methods
Measured: Change from Baseline plasma IL-10 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma Intercellular Adhesion Molecule 1 (ICAM-1) levels (ng/mL)
ICAM-1 levels will be measured by standardized chemiluminescence methods
Measured: Change from Baseline plasma ICAM-1 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma Cluster of Differentiation 14 (CD14) levels (pg/mL)
CD14 levels will be measured by standardized chemiluminescence methods
Measured: Change from Baseline plasma CD14 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma oxidized low density lipoproteins (LDLox) levels (mU/L)
LDLox levels will be measured by standardized chemiluminescence methods
Measured: Change from Baseline plasma LDLox levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum C-Reactive protein levels (mg/L)
C-Reactive protein levels will be determined by standardized spectrophotometry methods
Measured: Change from Baseline serum C-Reactive protein levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Histidine levels in blood (umol/L)
Serum histidine levels will be determined by Liquid Chromatography coupled to tandem Mass Spectrometry
Measured: Change from Baseline Histidine levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR)
HOMA-IR will be calculated using serum glucose and insulin levels.
Measured: Change from Baseline HOMA-IR at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Fatty Liver Index (FLI)
FLI will be calculated using BMI, waist circumference, serum triglycerides and gamma glutamyl transferase levels
Measured: Change from Baseline FLI at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Triglyceride glucose index (TyG)
TyG will be calculated using serum glucose and triglycerides levels
Measured: Change from Baseline TyG at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Plasma atherogenic index
Plasma atherogenic index will be calculated as the logarithm of the TG to HDL-c ratio
Measured: Change from Baseline Plasma atherogenic index at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Dietary habits
Nutritional habits will be determined based on the results obtained from the 3-day dietary record.
Measured: Change from Baseline Dietary habits at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Physical activity
Physical activity will be evaluated through the International Physical Activity Questionnaire (IPAQ)-short for physical activity questionnaire
Measured: Change from Baseline Physical activity at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in concomitant medication
The consumption of concomitant medication by the volunteers will be controlled by the record of concomitant medication in the case report form
Measured: Change from Baseline concomitant medication at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in the consumption of food supplements
The consumption of food supplements by the volunteers will be controlled by the record of food supplements in the case report form
Measured: Change from Baseline consumption of food supplements at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Analysis of genetic polymorphisms
Single Nucleotide Polymorphisms (SNPs) in saliva samples will be analysed by Illumina sequencing
Measured: Single nucleotide polymorphisms (SNPs) in loci of genetic susceptibility to abdominal adiposity will be studied at 12 weeks after treatment for each of the two treatments (multi-ingredient and placebo)
Change of Food Intake Biomarkers
Food Intake biomarkers will be evaluated in urine using Metabolomics analyses (UHPLC MS)
Measured: Change from Baseline Food Intake Biomarkers at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Adverse events
Possible adverse events derived from taking study's products will be recorded in the case report form
Measured: After 6 (V2) and 12 weeks (V3) of treatment period for each of the two treatments (multi-ingredient and placebo)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 May 2023
- Primary completion20 Dec 2023
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Diagnosi per la Imatge, Laboratorio de Referencia Sud, Centro OWLiver
- Responsible party
- Sponsor
- Investigators
- Xavier Escoté, PhD, Principal investigator, Eurecat, Technology Centre of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807204
- Sponsor's protocol ID
- FATHIS
- Acronym
- FATHIS
- Status last verified
- Feb 2024
- First submitted
- 15 Mar 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Individuals With Abdominal Obesity. Randomized, Parallel, Placebo Controlled, Triple Blind Study.
- ClinicalTrials.gov ID
- NCT05807204
- Acronym / sponsor ID
- FATHIS / FATHIS
- Keywords
- Nutraceuticals, Visceral Obesity, NAFLD, Metabolic risk, L-histidine, L-serine, N-Acetylcysteine, L-carnosine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- Centre de Diagnosi per la Imatge, Laboratorio de Referencia Sud, Centro OWLiver
- Study start
- 1 May 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine | Experimental | Dietary Supplement: Multi-ingredient of L-histidine, L-serine, L-carnosine and N-AcetylcysteineParticipants will daily consume the multi-ingredient (L-Histidine, L-Serine, L-Carnosine and N-Acetylcysteine) for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will daily consume the placebo (maltodextrin) for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-ingredient of L-histidine, L-serine, L-carnosine and N-AcetylcysteineThe product will be presented in powder format in a single container and with a measuring spoon of the daily dose. | Dietary supplement | Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine |
| PlaceboThe product will be presented in powder format in a single container and with a measuring spoon of the daily dose. | Dietary supplement | Placebo |
Primary outcome
Change in Visceral Adiposity
Time frame: Change from Baseline Visceral Adiposity at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Visceral fat content measured using a dual energy x-ray absorptiometry (DXA) scanner
44 secondary outcomes
Change in Hepatic Steatosis
Time frame: Change from Baseline Hepatic Steatosis at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Height (cm)
Time frame: At Baseline
Change in Weight (kg)
Time frame: 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)
Time frame: 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)
Time frame: Change from Baseline Neck circumference at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Arm circumference (cm)
Time frame: Change from Baseline Arm circumference at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Waist circumference (cm)
Time frame: Change from Baseline Waist circumference at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Conicity Index
Time frame: Change from Baseline Conicity Index at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Systolic Blood Pressure (mm Hg)
Time frame: Change from Baseline Systolic Blood Pressure at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Diastolic Blood Pressure (mm Hg)
Time frame: Change from Baseline Systolic Blood Pressure at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in intestinal microbiota composition
Time frame: Change from Baseline intestinal microbiota composition at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change of biomarkers of oxidative stress (8-OHdG, F2-isoprostanes)
Time frame: Change from Baseline biomarkers of oxidative stress at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum glucose levels (mg/dL)
Time frame: Change from Baseline serum glucose levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum total cholesterol (mg/dL)
Time frame: Change from Baseline serum total cholesterol at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum high-density lipoprotein cholesterol (HDL-C,mg/dL)
Time frame: Change from Baseline serum high-density lipoprotein cholesterol at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum low-density lipoprotein cholesterol (LDL-C, mg/dL)
Time frame: Change from Baseline serum low-density lipoprotein cholesterol at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum triglycerides (TG, mg/dL)
Time frame: Change from Baseline serum triglycerides at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum alanine aminotransferase (ALT, U/L)
Time frame: Change from Baseline serum alanine aminotransferase at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum aspartate aminotransferase (AST, U/L)
Time frame: Change from Baseline serum aspartate aminotransferase at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum gamma glutamyl transferase (GGT, U/L)
Time frame: Change from Baseline serum gamma glutamyl transferase at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum insulin levels (mU/L)
Time frame: Change from Baseline serum insulin levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum leptin levels (pg/mL)
Time frame: Change from Baseline serum leptin levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum adiponectin levels (ng/mL)
Time frame: Change from Baseline serum adiponectin levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Adiponectin/Leptin ratio (numerical ratio)
Time frame: Change from Baseline Adiponectin/Leptin ratio at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum Monocyte chemoattractant protein-1 (MCP-1) levels (pg/mL)
Time frame: Change from Baseline serum MCP-1 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma tumor necrosis factor alpha (TNF-alpha) levels (pg/mL)
Time frame: Change from Baseline plasma TNF-alpha levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma Interleukin 6 (IL-6) levels (pg/mL)
Time frame: Change from Baseline plasma IL-6 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma Interleukin 10 (IL-10) levels (pg/mL)
Time frame: Change from Baseline plasma IL-10 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma Intercellular Adhesion Molecule 1 (ICAM-1) levels (ng/mL)
Time frame: Change from Baseline plasma ICAM-1 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma Cluster of Differentiation 14 (CD14) levels (pg/mL)
Time frame: Change from Baseline plasma CD14 levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in plasma oxidized low density lipoproteins (LDLox) levels (mU/L)
Time frame: Change from Baseline plasma LDLox levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in serum C-Reactive protein levels (mg/L)
Time frame: Change from Baseline serum C-Reactive protein levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Histidine levels in blood (umol/L)
Time frame: Change from Baseline Histidine levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR)
Time frame: Change from Baseline HOMA-IR at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Fatty Liver Index (FLI)
Time frame: Change from Baseline FLI at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Triglyceride glucose index (TyG)
Time frame: Change from Baseline TyG at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Plasma atherogenic index
Time frame: Change from Baseline Plasma atherogenic index at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Dietary habits
Time frame: Change from Baseline Dietary habits at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Physical activity
Time frame: Change from Baseline Physical activity at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in concomitant medication
Time frame: Change from Baseline concomitant medication at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Technological Centre of Nutrition and Health. Eurecat\_ReusLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Escoté, PhD principal investigator
Eurecat, Technology Centre of Catalonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine in people with Visceral Obesity and Non-Alcoholic Fatty Liver Disease, run by Fundació Eurecat at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visceral Adiposity (time frame: Change from Baseline Visceral Adiposity at 12 weeks for each of the two treatments (multi-ingredient and placebo)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.