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The goal of this pilot study is to determine if taking a commercially available probiotic product can influence levels of vitamins B12, B6 and folate after a 4-week supplementation period in reproductive-aged women without any micronutrient deficiencies. The main question it aims to answer is:
• Does a probiotic product influence blood folate, vitamin B12 and B6 levels in reproductive-aged women when it is taken regularly for 4 weeks?
Participants in this clinical trial will consume the probiotic product containing multiple probiotic strains regularly for 4 weeks. One group will consume one capsule per day at a particular dose, and the second group will consume two capsules per day at another dose. Participants will also have to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic product (high dose) | Experimental | Probiotic product in capsule form to be consumed once per day over the course of the study. |
|
| Probiotic product (low dose) | Experimental | Probiotic product in capsule form to be consumed once per day over the course of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Capsule | Dietary Supplement | Jamieson 10 Billion Daily Maintenance Probiotic. The probiotic formulation contains Bifidobacterium animalis subsp. lactis (UABla-12), Lactobacillus paracasei (UALpc-04), Bifidobacterium breve (UABbr-11), Lactobacillus gasseri (UALg-05), Lactobacillus rhamnosus (UALr-06), Lactobacillus rhamnosus (UALr-18), Lactobacillus acidophilus (DDS-1), Lactobacillus plantarum (UALp-05), Bifidobacterium longum subsp. longum (UABl-14), Bifidobacterium bifidum (UABb-10), Lactobacillus casei (UALc-03), Lactobacillus reuteri (UALre-16), Lactococcus lactis (UALl-08), and Bifidobacterium longum subsp. infantis (UABi-13). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome - Folate, vitamin B12 and B6 concentrations at endline (4-week assessment) compared to baseline | Folate, vitamin B12 and B6 concentrations will be measured using standard clinical lab assay. | Baseline, 4 weeks |
| Receptivity Outcome | Participant receptivity captured using the receptivity questionnaire at baseline. | Baseline |
| Acceptability Outcome | Participant acceptability captured using the acceptability questionnaire at endline (4-week assessment). | 4 weeks |
| Safety Outcome - Reported adverse events at midline (2-week assessment) and endline (4-week assessment) | Reported adverse events, including detailed information related to these adverse events (e.g. frequency, severity, symptoms, timing), will be measured using the bi-weekly study diaries at midline and endline. Proportion of adverse events (AEs) will be measured at midline and endline. | 2 weeks, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of metabolites (circulating metabolome) at baseline, and endline (4-week assessment) | Functional metabolites in plasma will be measured by Liquid Chromatography-Mass Spectrometry (LC-MS) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS). | Baseline, 4 weeks |
| Dietary intake using 24-hour dietary recall at baseline and endline (4-week assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Gut microbial metagenome at baseline and endline (4-week assessment) | Bacterial genomic DNA will be isolated from stool samples and analysed by whole genome sequencing. Exploratory analyses of inferred function of the metagenome will be undertaken using compositional approaches and standardised pipelines to summarise relative taxonomic abundance, diversity and variance within and between groups (2,3). We will further assess metagenome inferred function (mapping reads to KEGG and HUMAnN3), and visualise using compositional and scale-aware approaches (4) (and relate to computationally-derived functions from metagenome data) by measuring functional metabolites (see outcome 7 for additional details). |
Inclusion Criteria:
Exclusion Criteria:
Women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin Connor, PhD | Contact | 613-520-2600 | kristin.connor@carleton.ca | |
| Tim Van Mieghem, MD, PhD | Contact | 416-586-4800 | tim.vanmieghem@sinaihealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kristin Connor, PhD | Carleton University | Principal Investigator |
| Tim Van Mieghem, MD, PhD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carleton University | Recruiting | Ottawa | Ontario | K1S 5B6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38587201 | Background | Pang Z, Lu Y, Zhou G, Hui F, Xu L, Viau C, Spigelman AF, MacDonald PE, Wishart DS, Li S, Xia J. MetaboAnalyst 6.0: towards a unified platform for metabolomics data processing, analysis and interpretation. Nucleic Acids Res. 2024 Jul 5;52(W1):W398-W406. doi: 10.1093/nar/gkae253. | |
| 25201272 | Background | Abdel Rahman AM, Pawling J, Ryczko M, Caudy AA, Dennis JW. Targeted metabolomics in cultured cells and tissues by mass spectrometry: method development and validation. Anal Chim Acta. 2014 Oct 3;845:53-61. doi: 10.1016/j.aca.2014.06.012. Epub 2014 Jun 12. |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Single-blind, dose-masked, randomized trial
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Single-blind, dose-masked trial with blinded investigator allocation.
|
Dietary recalls will be conducted using the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) for Canada 2018 (1). This tool measures all food and beverages consumed over a 24-hour period. Dietary recalls will be considered complete if participants provide a minimum of two days of 24-hour recalls. |
| Baseline, 4 weeks |
| Dietary intake - exploratory analyses at baseline and endline (4-week assessment) | The investigators will perform exploratory dietary intake analyses, including proportion of participants meeting dietary reference intakes, and dietary patterns of foods. | Baseline, 4 weeks |
| Dietary intake - HEI and DRI at baseline and endline (4-week assessment) | The investigators will perform exploratory dietary intake analyses, including the proportion of participants meeting the Healthy Eating Index (HEI), and Dietary Inflammatory Index (DRI). | Baseline, 4 weeks |
| Baseline, 4 weeks |
| Exploratory: Gut microbial metabolome at baseline and endline (4-week assessment) | Microbial metabolome (microbial products, short chain fatty acids, vitamins, metals/minerals) will be measured in both groups (5) and data related to computationally-derived functions from metagenome data) using LC-MS and ICP-MS. Data will be processed under standard pipelines with visualisation and pathway analysis by MetaboAnalyst and KEGG databases (6). | Baseline, 4 weeks |
| 24910773 | Background | Fernandes AD, Reid JN, Macklaim JM, McMurrough TA, Edgell DR, Gloor GB. Unifying the analysis of high-throughput sequencing datasets: characterizing RNA-seq, 16S rRNA gene sequencing and selective growth experiments by compositional data analysis. Microbiome. 2014 May 5;2:15. doi: 10.1186/2049-2618-2-15. eCollection 2014. |
| 27143475 | Background | Gloor GB, Wu JR, Pawlowsky-Glahn V, Egozcue JJ. It's all relative: analyzing microbiome data as compositions. Ann Epidemiol. 2016 May;26(5):322-9. doi: 10.1016/j.annepidem.2016.03.003. Epub 2016 Apr 2. |
| 21048977 | Background | Gloor GB, Hummelen R, Macklaim JM, Dickson RJ, Fernandes AD, MacPhee R, Reid G. Microbiome profiling by illumina sequencing of combinatorial sequence-tagged PCR products. PLoS One. 2010 Oct 26;5(10):e15406. doi: 10.1371/journal.pone.0015406. |
| 22704899 | Background | Subar AF, Kirkpatrick SI, Mittl B, Zimmerman TP, Thompson FE, Bingley C, Willis G, Islam NG, Baranowski T, McNutt S, Potischman N. The Automated Self-Administered 24-hour dietary recall (ASA24): a resource for researchers, clinicians, and educators from the National Cancer Institute. J Acad Nutr Diet. 2012 Aug;112(8):1134-7. doi: 10.1016/j.jand.2012.04.016. Epub 2012 Jun 15. No abstract available. |
| D019602 |
| Food and Beverages |