Visceral ObesityFATHIS+NCT06377631
Effect of Multi-ingredient on Visceral Adiposity & Non-alcoholic Fatty Liver Disease in Postmenopausal Women 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, run by Fundació Eurecat at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Visceral Obesity, Non-alcoholic Fatty Liver, Postmenopausal
- 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
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 7 Jun 2024to 8 Apr 2025
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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 locations and contacts
2 sites in 1 country.
Spain2 sites
Anna Crescenti
Reus, Catalonia. Spain, 43204
Fundació Eurecat
Reus, Tarragona, 43204
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 Postmenopausal Women With Abdominal Obesity
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.
Read the detailed 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).
- Conditions
- Visceral Obesity, Non-alcoholic Fatty Liver, Postmenopausal
- Being tested
- Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine, Placebo
- Keywords
- Nutraceuticals, Metabolic risk, Visceral obesity, NAFLD, Hepatic steatosis, Lipid metabolism, Cardiovascular risk, Postmenopause, Histidine
- Medical subject headings
- Obesity, Abdominal, Non-alcoholic Fatty Liver Disease, Fatty Liver
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 (53)
Height (cm)
Height measured with standardized method
Measured: At baseline
Age
The age of the volunteers will be recorded in the case report form.
Measured: At day -7 (pre-selection visit)
Ethnicity
The ethnicity of the volunteers will be recorded in the case report form.
Measured: At day -7 (pre-selection visit)
Change in Body 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 Hip circumference (cm)
Hip circumference using a measuring tape
Measured: Change from Baseline hip 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 Waist-to-Hip ratio
Waist and Hip circumference will be combined to report Waist-to-Hip ratio
Measured: Change from Baseline Waist-to-Hip ratio at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Lipid Accumulation Product (LAP)
Waist circumference and fasting plasma Triglycerides will be combined to report Lipid Accumulation Product
Measured: Change from Baseline Lipid Accumulation Product ratio 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 heart rate (bpm)
Heart rate will be measured using an automatic sphygmomanometer
Measured: Change from Baseline Heart rate at 6 and 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 Acylcarnitine levels in blood (umol/L)
Serum Acylcarnitine levels will be determined by Liquid Chromatography coupled to tandem Mass Spectrometry
Measured: Change from Baseline Acylcarnitine levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in 17-beta-estradiol (E2) levels in blood (pg/mL)
Serum 17-beta-estradiol (E2) levels will be determined by standardized chemiluminescence methods
Measured: Change from Baseline 17-beta-estradiol (E2) levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Follicle-stimulating hormone (FSH) levels in blood (mU/mL)
Follicle-stimulating hormone (FSH) levels will be determined by standardized chemiluminescence methods
Measured: Change from Baseline FSH 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 lipidomic profile
Lipidomic analyses will be done by Liquid Chromatography coupled to tandem Mass Spectrometry
Measured: Change from Baseline Lipidomic profile at 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 in the expression of lipid-metabolism genes in PBMC
Peripheral blood mononuclear cell (PBMC) will be isolated to obtain the RNA for gene expression analyses by Quantitative reverse transcription PCR (RT-qPCR)
Measured: Change from Baseline gene expression 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. Scores will be reported in categories: LOW activity levels, MODERATE activity levels or HIGH activity levels with the latter indicating better outcomes.
Measured: Change from Baseline Physical activity at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Concomitant medication
Concomitant medication consumed during the study will be recorded in the case report form.
Measured: At day -7 (pre-selection visit), day 1 (visit V1), day 43 (visit 2) and day 85 (visit 3)
Consumption of dietary supplements
Dietary supplements consumed during the study will be recorded in the case report form.
Measured: At day -7 (pre-selection visit), day 1 (visit V1), day 43 (visit 2) and day 85 (visit 3)
Change in the Supraclavicular skin temperature
Supraclavicular skin temperature will be measured with the FLIR T530 thermal imaging camera
Measured: Change from Baseline Supraclavicular skin temperature at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in postmenopausal symptoms
Postmenopausal symptoms will be evaluated through the Menopause Rating Scale (MRS) questionnaire. The MRS comprises 11 items representing various symptoms or complaints. Each symptom can be rated from 0 (indicating no complaints) to 4 points (indicating severe symptoms), depending on the perceived severity reported by the women completing the scale. The total MRS score ranges from 0 (asymptomatic) to 44 (maximum complaint severity).
Measured: Change from Baseline postmenopausal symptoms at 6 and 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: At 6 weeks (V2) and at 12 weeks (V3) 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 posted22 Apr 2024
- Study start7 Jun 2024
- Primary completion8 Apr 2025
- Study completion8 Apr 2025
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Diagnosi per la Imatge, Instituto de Investigación Biomédica de Girona (IDIBGI), Laboratorio de Referencia de Cataluña
- Responsible party
- Sponsor
- Investigators
- Antoni Caimari, PhD, Principal investigator, Fundació Eurecat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377631
- Sponsor's protocol ID
- FATHIS+
- Acronym
- FATHIS+
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2024
- Last updated
- 17 Apr 2025
- 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 17 Apr 2025. 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 Postmenopausal Women With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT06377631
- Acronym / sponsor ID
- FATHIS+ / FATHIS+
- Conditions
- Visceral Obesity, Non-alcoholic Fatty Liver, Postmenopausal
- Keywords
- Nutraceuticals, Metabolic risk, Visceral obesity, NAFLD, Hepatic steatosis, Lipid metabolism, Cardiovascular risk, Postmenopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- Centre de Diagnosi per la Imatge, Instituto de Investigación Biomédica de Girona (IDIBGI), Laboratorio de Referencia de Cataluña
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 22 Apr 2024 (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.
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.
Detailed 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).
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
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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
53 secondary outcomes
Height (cm)
Time frame: At baseline
Age
Time frame: At day -7 (pre-selection visit)
Ethnicity
Time frame: At day -7 (pre-selection visit)
Change in Body 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 Hip circumference (cm)
Time frame: Change from Baseline hip 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 Waist-to-Hip ratio
Time frame: Change from Baseline Waist-to-Hip ratio at 6 and 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Lipid Accumulation Product (LAP)
Time frame: Change from Baseline Lipid Accumulation Product ratio 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 heart rate (bpm)
Time frame: Change from Baseline Heart rate at 6 and 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 Acylcarnitine levels in blood (umol/L)
Time frame: Change from Baseline Acylcarnitine levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in 17-beta-estradiol (E2) levels in blood (pg/mL)
Time frame: Change from Baseline 17-beta-estradiol (E2) levels at 12 weeks for each of the two treatments (multi-ingredient and placebo)
Change in Follicle-stimulating hormone (FSH) levels in blood (mU/mL)
Time frame: Change from Baseline FSH 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)
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 17 Apr 2025.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link 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.
Antoni Caimari, PhD principal investigator
Fundació Eurecat
2 sites 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, run by Fundació Eurecat at 2 sites 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 6 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 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 17 Apr 2025.