Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06057389
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-09-14
Brief Title:
The Effects of Aronia Melanocarpa Extract on Obese Individuals With Impaired Fasting Blood Glucose
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
The Effects of Black Aronia Melanocarpa Extract Combined With a Energy-restricted Diet on Metabolic Indicators and Intestinal Microecology in Obese Individuals With Impaired Fasting Blood Glucose
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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 is closely related to many chronic diseases such as hypertension coronary heart disease hyperlipidemia type 2 diabetes fatty liver certain types of tumors etc which are associated with adverse health outcomes Limiting energy intake is one of the most important treatment measures for weight loss The fruits of Aronia melanocarpa Aronia berries have been found to show multiple bioactivities potentially beneficial to human health including antidiabetic anti-infective antineoplastic antiobesity antioxidant and gut microbiota-regulating activities Thus it is worth investigating whether consumption of aronia melanocarpa extract have additional benefits in improving anthropometric indicators glucose and lipid metabolism inflammatory status adipocyte cytokines and intestinal microbiota in obese individuals on the basis of an energy-restricted diet
Obese individuals will be divided into intervention group and control group in this 8-week trial Both groups will be given an energy-restricted diet with an additional dose of aronia melanocarpa extract in capsules in intervention group and an additional dose of maltodextrin in capsules in control group
Fecal and blood samples from participants before and after the intervention will be collected for the analysis of gut microbiota glucose and lipid metabolism inflammatory status and adipocyte cytokines
Obese individuals will be divided into intervention group and control group in this 8-week trial Both groups will be given an energy-restricted diet with an additional dose of aronia melanocarpa extract in capsules in intervention group and an additional dose of maltodextrin in capsules in control group
Fecal and blood samples from participants before and after the intervention will be collected for the analysis of gut microbiota glucose and lipid metabolism inflammatory status and adipocyte cytokines
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