Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT03692806
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2018-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of STABLOR® on Visceral Fat Mass Reduction in Patients With Metabolic Syndrome
Sponsor:
LNC THERAPEUTICS
Organization:
Study Overview
Official Title:
A 3-month Randomized Double Blind Placebo-controlled Multicenter Study to Assess the Efficacy of STABLOR® on Visceral Fat Mass Reduction in Patients With Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2020-12
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:
OBEMINALE2
Brief Summary:
The primary objective of the study is to assess the efficacy of STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome during 12 weeks of consumption.
Detailed Description:
It is expected that the food product STABLOR will reduce visceral fat mass in subjects with metabolic syndrome and therefore will improve cardiometabolic risk factors. The aim of the current study is to assess the impact of a 12-week intake of STABLOR, compared to a placebo, on visceral fat in patients with metabolic syndrome. The primary objective of the study is to assess the efficacy of 12-week STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome. The Secondary outcomes include Anthropometric measurements and body composition, metabolic syndrome status, STABLOR® metabolism, Cardiovascular biomarkers, Systemic inflammation, Quality of life and Behavior.
Study Oversight
Has Oversight DMC:
False
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?: