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

Vitamin B 12 Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05993962
• Other study ID #: H18-01353
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency

Intervention

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.

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.

Locations

Country	Name	City	State
Canada	BCCHR Clinical Research and Evaluation Unit (CREU)	Vancouver	British Columbia
Canada	UBC Western Nutrition Research Center (WNRC)	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Dairy Farmers of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma total folate concentration	Biomarker for folate status	Change after 8 weeks
Other	Plasma total folate concentration	Biomarker for folate status	Change after 4 weeks
Primary	Serum total B12 concentration	Direct biomarker of vitamin B12 status	Change after 8 weeks of intervention
Primary	Serum total B12 concentration	Direct biomarker of vitamin B12 status	Change after 4 weeks of intervention
Secondary	Serum holotranscobalamin (holoTC) concentration	Direct biomarker of vitamin B12 status	Change after 8 weeks
Secondary	Serum holotranscobalamin (holoTC) concentration	Direct biomarker of vitamin B12 status	Change after 4 weeks
Secondary	Plasma methylmalonic acid (MMA) concentration	Functional biomarker of vitamin B12 status	Change after 8 weeks
Secondary	Plasma methylmalonic acid (MMA) concentration	Functional biomarker of vitamin B12 status	Change after 4 weeks
Secondary	Plasma homocysteine concentration	Functional biomarker of vitamin B12 status	Change after 8 weeks
Secondary	Plasma homocysteine concentration	Functional biomarker of vitamin B12 status	Change after 4 weeks