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

Primary Purpose

Vitamin B 12 Deficiency

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fortified yoghurt
Control yoghurt
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin B 12 Deficiency focused on measuring Food fortification, Yogurt, Vitamin B12, Older adults, Fortified food, Yoghurt, Vitamin

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • BCCHR Clinical Research and Evaluation Unit (CREU)
  • UBC Western Nutrition Research Center (WNRC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Fortified group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Serum total B12 concentration
Direct biomarker of vitamin B12 status
Serum total B12 concentration
Direct biomarker of vitamin B12 status

Secondary Outcome Measures

Serum holotranscobalamin (holoTC) concentration
Direct biomarker of vitamin B12 status
Serum holotranscobalamin (holoTC) concentration
Direct biomarker of vitamin B12 status
Plasma methylmalonic acid (MMA) concentration
Functional biomarker of vitamin B12 status
Plasma methylmalonic acid (MMA) concentration
Functional biomarker of vitamin B12 status
Plasma homocysteine concentration
Functional biomarker of vitamin B12 status
Plasma homocysteine concentration
Functional biomarker of vitamin B12 status

Full Information

First Posted
December 6, 2022
Last Updated
August 14, 2023
Sponsor
University of British Columbia
Collaborators
Dairy Farmers of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT05993962
Brief Title
Effect of Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status in Older Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Dairy Farmers of Canada

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B 12 Deficiency
Keywords
Food fortification, Yogurt, Vitamin B12, Older adults, Fortified food, Yoghurt, Vitamin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants received one daily serving (provided in one cup of 150grams) of unfortified yoghurt for 8 weeks
Arm Title
Fortified group
Arm Type
Experimental
Arm Description
Participants received one daily serving (provided in one cup of 150grams) of yoghurt fortified with vitamin B12 for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortified yoghurt
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control yoghurt
Intervention Description
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 Outcome Measure Information:
Title
Serum total B12 concentration
Description
Direct biomarker of vitamin B12 status
Time Frame
Change after 8 weeks of intervention
Title
Serum total B12 concentration
Description
Direct biomarker of vitamin B12 status
Time Frame
Change after 4 weeks of intervention
Secondary Outcome Measure Information:
Title
Serum holotranscobalamin (holoTC) concentration
Description
Direct biomarker of vitamin B12 status
Time Frame
Change after 8 weeks
Title
Serum holotranscobalamin (holoTC) concentration
Description
Direct biomarker of vitamin B12 status
Time Frame
Change after 4 weeks
Title
Plasma methylmalonic acid (MMA) concentration
Description
Functional biomarker of vitamin B12 status
Time Frame
Change after 8 weeks
Title
Plasma methylmalonic acid (MMA) concentration
Description
Functional biomarker of vitamin B12 status
Time Frame
Change after 4 weeks
Title
Plasma homocysteine concentration
Description
Functional biomarker of vitamin B12 status
Time Frame
Change after 8 weeks
Title
Plasma homocysteine concentration
Description
Functional biomarker of vitamin B12 status
Time Frame
Change after 4 weeks
Other Pre-specified Outcome Measures:
Title
Plasma total folate concentration
Description
Biomarker for folate status
Time Frame
Change after 8 weeks
Title
Plasma total folate concentration
Description
Biomarker for folate status
Time Frame
Change after 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Lamers, PhD
Organizational Affiliation
Associate Professor, UBC Food, Nutrition and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
BCCHR Clinical Research and Evaluation Unit (CREU)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4H4
Country
Canada
Facility Name
UBC Western Nutrition Research Center (WNRC)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada

12. IPD Sharing Statement

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

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