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

NCT ID: NCT05993962

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2020-12-31

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.

Conditions

Vitamin B 12 Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

Participants received one daily serving (provided in one cup of 150grams) of unfortified yoghurt for 8 weeks

Group Type: PLACEBO_COMPARATOR

Control yoghurt

Intervention Type: OTHER

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.

Fortified group

Participants received one daily serving (provided in one cup of 150grams) of yoghurt fortified with vitamin B12 for 8 weeks

Group Type: EXPERIMENTAL

Fortified yoghurt

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dairy Farmers of Canada

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Yvonne Lamers

Associate Professor, Food, Nutrition and Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yvonne Lamers, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, UBC Food, Nutrition and Health

Locations

BCCHR Clinical Research and Evaluation Unit (CREU)

Vancouver, British Columbia, Canada

UBC Western Nutrition Research Center (WNRC)

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H18-01353

Identifier Type: -

Identifier Source: org_study_id