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Completed

NCT Number: NCT05993962

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BCCHR Clinical Research and Evaluation Unit (CREU), Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Dairy Farmers of Canada

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 15, 2023
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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