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

NCT05993962 | Completed

• 1 other identifier: H18-01353
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Serum holotranscobalamin (holoTC) concentration

  Change after 8 weeks

• Serum holotranscobalamin (holoTC) concentration

  Change after 4 weeks

• Plasma methylmalonic acid (MMA) concentration

  Change after 8 weeks

• Plasma methylmalonic acid (MMA) concentration

  Change after 4 weeks

• Plasma homocysteine concentration

  Change after 8 weeks

Other Outcomes (2)

• Plasma total folate concentration

  Change after 8 weeks

• Plasma total folate concentration

  Change after 4 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Other: Control yoghurt

Fortified group

EXPERIMENTAL

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

Dietary Supplement: Fortified yoghurt

Interventions

Fortified yoghurt 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.

Fortified group

Control yoghurt 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.

Control group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Dairy Farmers of Canada: collaborator

Study Sites (2)

BCCHR Clinical Research and Evaluation Unit (CREU)

Vancouver, British Columbia, V5Z 4H4, Canada

Location

UBC Western Nutrition Research Center (WNRC)

Vancouver, British Columbia, V6T 1Z4, Canada

Location

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Yvonne Lamers, PhD

  Associate Professor, UBC Food, Nutrition and Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Food, Nutrition and Health

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: August 15, 2023
• Study Start: January 10, 2019
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2020
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

CA (2)