Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344377
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-27
Brief Title:
Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women
Sponsor:
Poznan University of Life Sciences
Organization:
Poznan University of Life Sciences
Study Overview
Official Title:
The Impact of Betaine Supplementation on Body Composition and Lipid Metabolism in a Group of Overweight and Obese Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
Obesity represents a serious global health issue with significant consequences including an increased risk of chronic diseases Statistics indicate a growing trend of obesity highlighting the need to seek methods that improve fat tissue metabolism and reduce obesity-related complications Previous research on animals has shown that betaine a substance engaged in one-carbon metabolism may enhance fat oxidation and lower adipose tissue Therefore the aim of the research will be to assess the impact of 8-week betaine supplementation on body composition and lipid metabolism markers as well as expression of genes related to lipid metabolism in a group of adult women with abdominal obesity
This study is designed in a placebo-controlled double-blinded randomized fashion The participants will be overweight or obese pre-menopausal females Upon enrollment participants will be randomly assigned to one of two parallel groups betaine 3gd or placebo The supplementation period will last for 8 weeks There will be three study meetings T1 before supplementation T2 after 4 weeks of supplementation and T3 after 8 weeks of supplementation Blood will be drawn and body composition measured and adipose tissue biopsy taken at meetings T1 and T3 The T2 meeting will involve only body composition measurement Study outcomes will include body mass and composition including body fat percent lipid profile and the expression of genes related to lipid metabolism in adipose tissue and peripheral blood mononuclear cells
This study is designed in a placebo-controlled double-blinded randomized fashion The participants will be overweight or obese pre-menopausal females Upon enrollment participants will be randomly assigned to one of two parallel groups betaine 3gd or placebo The supplementation period will last for 8 weeks There will be three study meetings T1 before supplementation T2 after 4 weeks of supplementation and T3 after 8 weeks of supplementation Blood will be drawn and body composition measured and adipose tissue biopsy taken at meetings T1 and T3 The T2 meeting will involve only body composition measurement Study outcomes will include body mass and composition including body fat percent lipid profile and the expression of genes related to lipid metabolism in adipose tissue and peripheral blood mononuclear cells
Detailed Description:
None
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