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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of The Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status of Healthy Older Adults - A Double-blind, Randomized Controlled Trial

Conditions
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Vitamin B 12 Deficiency

Intervention / Treatment
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* Dietary Supplement: Fortified yoghurt
* Other: Control yoghurt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Participants received one daily serving (provided in one cup of 150grams) of unfortified yoghurt for 8 weeks | Other: Control yoghurt<br>* 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.<br>|
| Experimental: Fortified group<br>Participants received one daily serving (provided in one cup of 150grams) of yoghurt fortified with vitamin B12 for 8 weeks | Dietary Supplement: Fortified yoghurt<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum holotranscobalamin (holoTC) concentration | Direct biomarker of vitamin B12 status | Change after 8 weeks | 
| Serum holotranscobalamin (holoTC) concentration | Direct biomarker of vitamin B12 status | Change after 4 weeks | 
| Plasma methylmalonic acid (MMA) concentration | Functional biomarker of vitamin B12 status | Change after 8 weeks | 
| Plasma methylmalonic acid (MMA) concentration | Functional biomarker of vitamin B12 status | Change after 4 weeks | 
| Plasma homocysteine concentration | Functional biomarker of vitamin B12 status | Change after 8 weeks | 
| Plasma homocysteine concentration | Functional biomarker of vitamin B12 status | Change after 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yogurt, Food fortification, Vitamin B12, Older adults, Fortified food, Yoghurt, Vitamin