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

• ClinicalTrials.gov Identifier: NCT05993962
• Recruitment Status: Completed
• First Posted: August 15, 2023
• Last Update Posted: August 15, 2023
• Sponsor: University of British Columbia
• Collaborator: Dairy Farmers of Canada
• Information provided by (Responsible Party): Yvonne Lamers, University of British Columbia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vitamin B 12 Deficiency	Dietary Supplement: Fortified yoghurt; Other: Control yoghurt	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: January 10, 2019
• Actual Primary Completion Date: October 31, 2019
• Actual Study Completion Date: December 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Serum total B12 concentration [ Time Frame: Change after 8 weeks of intervention ]
   Direct biomarker of vitamin B12 status
2. Serum total B12 concentration [ Time Frame: Change after 4 weeks of intervention ]
   Direct biomarker of vitamin B12 status

Secondary Outcome Measures :

1. Serum holotranscobalamin (holoTC) concentration [ Time Frame: Change after 8 weeks ]
   Direct biomarker of vitamin B12 status
2. Serum holotranscobalamin (holoTC) concentration [ Time Frame: Change after 4 weeks ]
   Direct biomarker of vitamin B12 status
3. Plasma methylmalonic acid (MMA) concentration [ Time Frame: Change after 8 weeks ]
   Functional biomarker of vitamin B12 status
4. Plasma methylmalonic acid (MMA) concentration [ Time Frame: Change after 4 weeks ]
   Functional biomarker of vitamin B12 status
5. Plasma homocysteine concentration [ Time Frame: Change after 8 weeks ]
   Functional biomarker of vitamin B12 status
6. Plasma homocysteine concentration [ Time Frame: Change after 4 weeks ]
   Functional biomarker of vitamin B12 status

Other Outcome Measures:

1. Plasma total folate concentration [ Time Frame: Change after 8 weeks ]
   Biomarker for folate status
2. Plasma total folate concentration [ Time Frame: Change after 4 weeks ]
   Biomarker for folate status

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Canada, British Columbia

BCCHR Clinical Research and Evaluation Unit (CREU)

Vancouver, British Columbia, Canada, V5Z 4H4

UBC Western Nutrition Research Center (WNRC)

Vancouver, British Columbia, Canada, V6T 1Z4

Sponsors and Collaborators

University of British Columbia

Dairy Farmers of Canada

Investigators

• Principal Investigator: Yvonne Lamers, PhD; Associate Professor, UBC Food, Nutrition and Health

More Information

• Responsible Party: Yvonne Lamers, Associate Professor, Food, Nutrition and Health, University of British Columbia
• ClinicalTrials.gov Identifier: NCT05993962
• Other Study ID Numbers: H18-01353
• First Posted: August 15, 2023
• Last Update Posted: August 15, 2023
• Last Verified: August 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yvonne Lamers, University of British Columbia:

Food fortification; Yogurt; Vitamin B12; Older adults; Fortified food; Yoghurt; Vitamin

Additional relevant MeSH terms:

Vitamin B 12 Deficiency; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders