Status:
COMPLETED
Effect of Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status in Older Adults
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Dairy Farmers of Canada
Conditions:
Vitamin B 12 Deficiency
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
Older adults are recommended to meet their daily vitamin B12 (B12) requirements by consuming foods with added B12 and/or taking B12 supplements (i.e. sources of free B12) because of an age-related dec...
Eligibility Criteria
Inclusion
- Non-smoking and apparently healthy female and male volunteers aged 50-75 years, who are comfortable speaking, reading and understanding English.
Exclusion
- Chronic health conditions, especially those related to B12 metabolism and the digestive tract. Chronic health conditions include diabetes, cancer, liver disease, psychiatric illnesses (depression, bipolar disorder, schizophrenia, anxiety disorder, eating disorder), cardiovascular disease, renal impairment, pancreatic dysfunction, gastrointestinal diseases (such as, Crohn's disease, Irritable Bowel Syndrome, Colitis, pernicious anemia, Celiac disease, acid indigestion, constipation, diverticulitis/ diverticulosis, gastroesophageal reflux disorder, or atrophic gastritis), total or partial gastrectomy, gastric bypass or other bariatric surgery, ileal resection or organ reconstructive surgery.
- Use of prescription or over-the-counter medications that may interfere with B12 status, i.e., Metformin, anti-cancer treatment, antibiotics, proton pump inhibitors, antacids; the use of high-dose B12 supplements for the last 1 month (e.g., 1000ug of B12 per day); intramuscular B12 injections in the last 1 month; vitamin supplements containing B-vitamins over the past three months; or Brewer's yeast over the past three months.
- Individuals who are unwilling to consume one daily serving of yoghurt for 8 weeks, provide blood samples and measures of height and weight, enroll and start the study in early 2019, or come to the University of British Columbia (UBC) or the BC Children's Hospital Research Institute (BCCHRI) site for study visits.
- Participants with deficient or high serum total B12 concentrations (\<148 and \>400pmol/L)
- Individuals with allergies or sensitivities to any ingredients of yoghurt (i.e. dairy)
- Individuals who smoke or consume more than one drink containing alcohol each day
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05993962
Start Date
January 10 2019
End Date
December 31 2020
Last Update
August 15 2023
Active Locations (2)
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1
BCCHR Clinical Research and Evaluation Unit (CREU)
Vancouver, British Columbia, Canada, V5Z 4H4
2
UBC Western Nutrition Research Center (WNRC)
Vancouver, British Columbia, Canada, V6T 1Z4