Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-02 @ 6:55 AM
Study NCT ID:
NCT04058392
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2019-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Camu Camu in ART-treated People Living with HIV
Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Organization:
Study Overview
Official Title:
FULL TITLE: Camu Camu Effects on Circulating LPS and Systemic Immune Activation in ART-treated Participants: the Camu Camu Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-11
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:
Persons living with HIV and receiving antiretroviral therapy (ART) remain with inflammation leading to higher risks of cardiovascular diseases, fatty liver and cancer. It has been observed in colitis and in HIV infection that abnormal composition of the gut microbes and leaky gut induce inflammation contributing to diabetes, fatty liver and cardiovascular risks. Abundance of Akkermansia muciniphila in stool, a type of good bacteria acting as a shield on the gut barrier has been shown to prevent obesity, diabetes and to improve cancer treatment response. Health food (prebiotic) increases the frequency of A. muciniphila in overweight individuals.
Dr Marette, a study collaborator from Laval University, has recently published (Gut, 2018) that an extract from a Brazilian fruit called Camu Camu (CC) protects mice from obesity, reduce LPS, a marker for passage of microbes from the gut into the blood and decreases inflammation in association with the frequency of A. muciniphila in stools. The extract of CC is sold in nutritional stores to regulate body fat.
The investigators will invite 22 participants to take 2 capsules of CC daily for 12 weeks in addition to their ART. CC tolerance and changes in blood and stools for inflammation and microbe composition will be evalutated at the end of the 12-week treatment and 8 weeks post-intake. An optional sub study will assess the changes of gut barrier by doing biopsies by colonoscopy.
CC is expected to beassociated with an enrichment of A. muciniphila in stools, combined with reduced gut damage and inflammation.
Dr Marette, a study collaborator from Laval University, has recently published (Gut, 2018) that an extract from a Brazilian fruit called Camu Camu (CC) protects mice from obesity, reduce LPS, a marker for passage of microbes from the gut into the blood and decreases inflammation in association with the frequency of A. muciniphila in stools. The extract of CC is sold in nutritional stores to regulate body fat.
The investigators will invite 22 participants to take 2 capsules of CC daily for 12 weeks in addition to their ART. CC tolerance and changes in blood and stools for inflammation and microbe composition will be evalutated at the end of the 12-week treatment and 8 weeks post-intake. An optional sub study will assess the changes of gut barrier by doing biopsies by colonoscopy.
CC is expected to beassociated with an enrichment of A. muciniphila in stools, combined with reduced gut damage and inflammation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: