Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377631
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-17
Brief Title:
Effect of Multi-ingredient on Visceral Adiposity Non-alcoholic Fatty Liver Disease in Postmenopausal Women With Abdominal Obesity
Sponsor:
Fundació Eurecat
Organization:
Fundació Eurecat
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FATHIS
Brief 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
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 111 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
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 111 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None