Clinical trial NCT05993962: Effect of Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status in Older Adults
Official title: Efficacy of The Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status of Healthy Older Adults - A Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin B 12 Deficiency
Keywords: Food fortification
Yogurt
Vitamin B12
Older adults
Fortified food
Yoghurt
Vitamin
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Dairy Farmers of Canada
First posted: 2023-08-15
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 decreased digestion and absorption capacity for food-bound B12. Currently, B12 is not added to foods in Canada, except for simulated dairy and meat products. Yoghurt with added B12 is a novel dairy product that could fill a gap that presently exists in the Canadian market and has the potential to provide Canadian older adults with an alternative dietary source of B12 that could help improve their B12 status. Thus, the objective of this study was to assess the efficacy of the daily consumption of one serving of yoghurt fortified with B12 versus unfortified yoghurt for 8 weeks on the B12 status of healthy older adults, assessed using serum total B12. The primary hypothesis of this study was that the daily consumption of B12-fortified yoghurt would increase serum total B12 concentration of older adults compared to the consumption of unfortified yoghurts.


Eligibility criteria: Inclusion Criteria: Non-smoking and apparently healthy female and male volunteers aged 50-75 years, who are comfortable speaking, reading and understanding English.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Serum total B12 concentration
timeFrame: Change after 8 weeks of intervention
measure: Serum total B12 concentration
timeFrame: Change after 4 weeks of intervention
Secondary outcomes:
measure: Serum holotranscobalamin (holoTC) concentration
timeFrame: Change after 8 weeks
measure: Serum holotranscobalamin (holoTC) concentration
timeFrame: Change after 4 weeks
measure: Plasma methylmalonic acid (MMA) concentration
timeFrame: Change after 8 weeks
measure: Plasma methylmalonic acid (MMA) concentration
timeFrame: Change after 4 weeks
measure: Plasma homocysteine concentration
timeFrame: Change after 8 weeks
measure: Plasma homocysteine concentration
timeFrame: Change after 4 weeks
Other outcomes:
measure: Plasma total folate concentration
timeFrame: Change after 8 weeks
measure: Plasma total folate concentration
timeFrame: Change after 4 weeks
Locations:
city: Vancouver
country: Canada
facility: BCCHR Clinical Research and Evaluation Unit (CREU)
state: British Columbia
city: Vancouver
country: Canada
facility: UBC Western Nutrition Research Center (WNRC)
state: British Columbia
Study officials:
affiliation: Associate Professor, UBC Food, Nutrition and Health
name: Yvonne Lamers, PhD
role: PRINCIPAL_INVESTIGATOR
References: