Camu Camu in ART-treated People Living with HIV
- Conditions
- HIV Infections
- Interventions
- Biological: Camu Camu Capsules
- Registration Number
- NCT04058392
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Camu Camu Camu Camu Capsules Assessments will be done at baseline, during and after 12 weeks of Camu Camu intake.
- Primary Outcome Measures
Name Time Method Reduction of the plasma marker of microbial translocation LPS, assessed using ELISA. 12 weeks
- Secondary Outcome Measures
Name Time Method Changes in HIV reservoir size in biopsies using qPCR 12 weeks Association between baseline gut microbiota composition (16S rDNA sequencing), and markers of gut integrity (I-FABP, tissue staining) and inflammation (T-cell activation, inflammatory cytokines). 2 weeks Safety and tolerability of CC 20 weeks measured by evaluating adverse events, hematology, and serum chemistries over the course of the study. These evaluations will include HIV viral load, glucose levels, a lipid profile and plasma levels of hsCRP and D-dimer.
Changes in gut integrity markers I-FABP, and sST2, measured by ELISA 12 weeks and 20 weeks Changes in microbial translocation marker 1-3-b-D-Glucan assessed using the Fungitell assay 12 weeks and 20 weeks. Changes in pro-inflammatory markers (IL-1β, IL-6, IL-8, IL-18. IP-10, IL-17A and F, IL-22, and soluble CD14) and anti-inflammatory markers (IL-10) assessed by ELISA. 12 weeks and 20 weeks Changes in T-cell and monocyte activation levels assessed by flow cytometry using markers CD38, HLA-DR and PD-1 12 weeks and 20 weeks Changes in A. muciniphila levels in stools using qPCR 12 weeks and 20 wekks Changes in microbiota composition and diversity in stools assessed using 16s rDNA sequencing 12 weeks and 20 wekks Changes in HIV reservoir size in blood assessed by PCR 12 weeks and 20 wekks Evaluate intra-patient variability using data from two baseline visits, approximately two weeks apart from each other to confirm reliability of baseline results. 2 weeks Changes in gut mucosa architecture in a subset of participants who will consent to have colon biopsies before and at the end of the 12 weeks of CC treatment. 12 weeks Changes in inflammation in gut mucosa biopsy assessed by myeloperoxidase staining before and at the end of the 12 weeks of CC treatment 12 weeks
Trial Locations
- Locations (1)
Mcgill University Health Center
🇨🇦Montreal, Quebec, Canada