Effect of Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status in Older Adults

Efficacy of The Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status of Healthy Older Adults - A Double-blind, Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Vitamin B 12 Deficiency
• Intervention / Treatment: Other: Control yoghurt; Dietary supplement: Fortified yoghurt

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4H4
      • BCCHR Clinical Research and Evaluation Unit (CREU)
    • Vancouver, British Columbia, Canada, V6T 1Z4
      • UBC Western Nutrition Research Center (WNRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Participants received one daily serving (provided in one cup of 150grams) of unfortified yoghurt for 8 weeks	Other: Control yoghurt; Yoghurts were locally produced by a yoghurt company in British Columbia, Canada. Yoghurts produced were Greek-style and packaged into white cups, each containing 150 grams of yoghurt, labelled with the date of production and study code.
Experimental: Fortified group; Participants received one daily serving (provided in one cup of 150grams) of yoghurt fortified with vitamin B12 for 8 weeks	Dietary supplement: Fortified yoghurt; Food-grade vitamin B12 in the form of methylcobalamin (purity: 99%) was used for fortification. Yoghurts were Greek-style and locally produced by a yoghurt company in British Columbia, Canada. The pre-measured vitamin B12 was added into yoghurt vats in amounts that corresponded to the chosen dosage (50 µg of B12 per 150 g). The yoghurt was packaged into white cups, each containing 150 grams of yoghurt, labelled with the date of production and study code.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum total B12 concentration	Direct biomarker of vitamin B12 status	Change after 8 weeks of intervention
Serum total B12 concentration	Direct biomarker of vitamin B12 status	Change after 4 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum holotranscobalamin (holoTC) concentration	Direct biomarker of vitamin B12 status	Change after 8 weeks
Serum holotranscobalamin (holoTC) concentration	Direct biomarker of vitamin B12 status	Change after 4 weeks
Plasma methylmalonic acid (MMA) concentration	Functional biomarker of vitamin B12 status	Change after 8 weeks
Plasma methylmalonic acid (MMA) concentration	Functional biomarker of vitamin B12 status	Change after 4 weeks
Plasma homocysteine concentration	Functional biomarker of vitamin B12 status	Change after 8 weeks
Plasma homocysteine concentration	Functional biomarker of vitamin B12 status	Change after 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma total folate concentration	Biomarker for folate status	Change after 8 weeks
Plasma total folate concentration	Biomarker for folate status	Change after 4 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Dairy Farmers of Canada
• Investigators: Principal Investigator: Yvonne Lamers, PhD, Associate Professor, UBC Food, Nutrition and Health

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin B12; Older adults; Fortified food; Yogurt; Yoghurt; Vitamin; Food fortification
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Vitamin B 12 Deficiency
• Other Study ID Numbers: H18-01353

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No