Probiotic Intervention
Conditions
Keywords
B vitamins, Reproductive-aged women, Probiotics
Brief summary
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: * Attend two in-person visits with a researcher: at enrolment (baseline), and endline (day 28/4 weeks) * Provide a blood sample at baseline (day 0) and endline (day 28/4 weeks) * Provide two stool samples (following each in-person visit) * Complete an online "study diary" every two weeks for 4 weeks (2 study diaries) * Complete two sets of online questionnaires (following each in-person visit) * Complete two sets of dietary assessments (following each in-person visit)
Interventions
DIETARY_SUPPLEMENTProbiotic Capsule
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).
Sponsors
Carleton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Single-blind, dose-masked trial with blinded investigator allocation.
Intervention model description
Single-blind, dose-masked, randomized trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Non-pregnant and non-lactating * English speaking with the ability to give informed consent * 18-40 years of age (inclusive) * Women who are biologically female * Willing and able to agree to the requirements and lifestyle restrictions of this study * Able to understand and read the questionnaires in English and carry out all study-related procedures * Located in the greater Ottawa area and a resident of Ontario
Exclusion criteria
* Individuals who are lactating, pregnant, or planning to become pregnant during the study * Individuals who are not maintaining adequate birth control measures * Adequate birth control measures include any option that will adequately prevent pregnancy including: contraceptives, lifestyle choices, complete abstinence, or as a result of other medical methods, procedures, or conditions * Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients * Are using vitamin and mineral supplements containing B vitamins * Intake of a B-vitamin-containing micronutrient supplement or probiotic product in the previous 4 weeks * Expecting to change diet and exercise regimen in the next 4 weeks * Have planned surgery during the course of the study * Use of investigational product(s) in another research study within 30 days prior to the baseline visit or during the study duration * Taking probiotics during the study period * More than 2 alcoholic beverages per day throughout the duration of the study * Known medical history of specific conditions including: Gastrointestinal disorders: celiac disease, ulcerative colitis, and Crohn's disease; Gastric cancer and gastric polyps; Inflammatory bowel diseases; Helicobacter pylori infection; Gastrectomy, duodenal bypass, bariatric surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome - Folate, vitamin B12 and B6 concentrations at endline (4-week assessment) compared to baseline | Baseline, 4 weeks | Folate, vitamin B12 and B6 concentrations will be measured using standard clinical lab assay. |
| Receptivity Outcome | Baseline | Participant receptivity captured using the receptivity questionnaire at baseline. |
| Acceptability Outcome | 4 weeks | Participant acceptability captured using the acceptability questionnaire at endline (4-week assessment). |
| Safety Outcome - Reported adverse events at midline (2-week assessment) and endline (4-week assessment) | 2 weeks, 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of metabolites (circulating metabolome) at baseline, and endline (4-week assessment) | Baseline, 4 weeks | Functional metabolites in plasma will be measured by Liquid Chromatography-Mass Spectrometry (LC-MS) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS). |
| Dietary intake using 24-hour dietary recall at baseline and endline (4-week assessment) | Baseline, 4 weeks | 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. |
| Dietary intake - exploratory analyses at baseline and endline (4-week assessment) | Baseline, 4 weeks | The investigators will perform exploratory dietary intake analyses, including proportion of participants meeting dietary reference intakes, and dietary patterns of foods. |
| Dietary intake - HEI and DRI at baseline and endline (4-week assessment) | Baseline, 4 weeks | The investigators will perform exploratory dietary intake analyses, including the proportion of participants meeting the Healthy Eating Index (HEI), and Dietary Inflammatory Index (DRI). |
Countries
Canada
Contacts
CONTACTKristin Connor, PhD
CONTACTTim Van Mieghem, MD, PhD
PRINCIPAL_INVESTIGATORKristin Connor, PhD
Carleton University
PRINCIPAL_INVESTIGATORTim Van Mieghem, MD, PhD
MOUNT SINAI HOSPITAL
Outcome results
None listed