Postmenopausal Clinical Trial
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.
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). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02235051 -
Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors
|
N/A | |
| Completed |
NCT01635413 -
Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
|
N/A | |
| Completed |
NCT00701337 -
Effect of 17ß-estradiol on Inflammatory-immune Responses in Post-menopausal Women According to Administration Route
|
Phase 4 | |
| Recruiting |
NCT04705623 -
Influence of Iyengar Yoga on the Bio-functional Age of Postmenopausal Women
|
N/A | |
| Withdrawn |
NCT03238703 -
Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer
|
Phase 4 | |
| Completed |
NCT03756272 -
Stellate Ganglion Block to Reduce Hot Flushes
|
N/A | |
| Recruiting |
NCT03953157 -
Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors
|
N/A | |
| Completed |
NCT00338728 -
Letrozole and Imatinib Mesylate in Treating Postmenopausal Participants With Estrogen or Progesterone Positive Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT01482702 -
Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors
|
N/A | |
| Not yet recruiting |
NCT05009238 -
Effect of l S Exercises on Balance and Spatiotemporal Gait Parameters in P M Women
|
N/A | |
| Terminated |
NCT01842217 -
Validation of [18F]FES for Imaging of Brain Estrogen Receptors
|
N/A | |
| Completed |
NCT01172574 -
Motor Control Exercise in Osteoporotic Women
|
N/A | |
| Completed |
NCT00530582 -
Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women
|
Phase 4 | |
| Completed |
NCT01825785 -
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)
|
Phase 1 | |
| Completed |
NCT04364061 -
Post Exercise Substrate Oxidation, Appetite and Energy Intakes in Overweight/Obese Postmenopausal Women (EScAPE)
|
N/A | |
| Completed |
NCT03180294 -
Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer
|
Phase 2 | |
| Completed |
NCT01753908 -
Broccoli Sprout Extract in Treating Patients With Breast Cancer
|
Early Phase 1 | |
| Recruiting |
NCT06228768 -
Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast Cancer
|
N/A | |
| Terminated |
NCT01294397 -
Effects of Denosumab on the Pharmacokinetics of Etanercept
|
Phase 1 | |
| Completed |
NCT00603967 -
Effect of Aromatase Inhibitors on Bones and Genes
|
N/A |