Effectiveness of a fortified drink at improving B vitamin biomarkers in older adults

ISRCTN ISRCTN61709781
DOI https://doi.org/10.1186/ISRCTN61709781
Secondary identifying numbers LS-18-60
Submission date
27/07/2021
Registration date
28/07/2021
Last edited
12/04/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Many older Irish adults are reported to have low B vitamin levels, while insufficient folate and vitamin B12 is much more common among non-consumers of fortified foods compared to regular consumers. Therefore, new strategies, including new foods targeted at older people, are needed to improve B vitamin levels.
Fortified drinks may improve vitamin status, but most previous studies that investigated the effect of fortified drinks on blood biomarkers were performed in children and included multiple vitamins and minerals to improve nutritional status in areas where deficiencies are common. A limited number of studies investigated the effect of B vitamin fortified drinks in improving B vitamin levels in older adults.
The aim of this study is to investigate the effectiveness of a novel drink product, fortified with folic acid, vitamin B12, vitamin B6 and riboflavin, in optimising B vitamin status in healthy older adults.

Who can participate?
Healthy older adults aged 50 years and over

What does the study involve?
Participants are randomly allocated to receive either a drink supplemented with B vitamins or a placebo (dummy) drink. Measurements include the following: blood samples to measure levels of vitamins B and D, weight, height, waist circumference, hip circumference, and blood pressure. Participants consume the drink once daily for 16 weeks and then measurements are repeated to see if there were any improvements.

What are the possible benefits and risks of participating?
There is no direct benefit to the participants. A small percentage of people feel faint or faint after giving blood. The researchers asked all participants to rest for a few minutes following the blood collection. Trained phlebotomists or health care individuals take the blood samples.

Where is the study run from?
University College Dublin (Ireland) and Ulster University (UK)

When is the study starting and how long is it expected to run for?
January 2017 to January 2020

Who is funding the study?
1. Department of Agriculture, Food and the Marine (Ireland)
2. Department of Agriculture, Environment and Rural Affairs (UK)
3. Smartfish AS (Norway)

Who is the main contact?
Prof. Lorraine Brennan
lorraine.brennan@ucd.ie

Contact information

Dr Lorraine Brennan
Public

University College Dublin
Belfield
Dublin 4
Dublin
D04 V1W8
Ireland

ORCiD logo 0000-0002-7711-7499
+353 (0)17166815
lorraine.brennan@ucd.ie

Study information

Study designDouble-blind randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEffectiveness of a fortified drink at improving B vitamin biomarkers in older adults: a controlled intervention trial
Study acronymOpti-Age
Study objectivesA B vitamin-fortified drink is effective at improving B vitamin biomarkers in older Irish adults.
Ethics approval(s)1. Approved 28/06/2018, UCD Human Research Ethics Committee (Roebuck Castle, University College Dublin, Belfield, Dublin 4, Ireland; +353 (0)1 716 8767; hrec@ucd.ie), ref: LS-18-60-Brennan
2. Approved 28/06/2018, Ulster University Research Ethics Committee (Cromore Road, Coleraine, BT52 1SA, UK; +44 (0)28 9536 7124; cherp@ulster.ac.uk), ref: UU: REC/18/0033
Health condition(s) or problem(s) studiedImproving B vitamin biomarkers
InterventionParticipants are randomised by block randomisation to one of two groups:
1. Intervention group receive a 200 ml drink manufactured to contain 200 µg folic acid, 10 µg vitamin B12, 10 mg vitamin B6 and 5 mg riboflavin in the active version.
2. Control group receive a placebo drink in an identical presentation, isocaloric formulation which did not contain B vitamins.

Both the intervention and placebo drinks contain 10 µg vitamin D. Participants consume the drink once daily for 16 weeks.
Intervention typeSupplement
Primary outcome measure1. B vitamin biomarker concentrations measured at baseline and 16 weeks:
1.1. Riboflavin measured by erythrocyte glutathione reductase activation coefficient assay (EGRac)
1.2. Serum folate concentrations measured by a microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei
1.3. Serum vitamin B12 determined by microbiological assay using Lactobacillus leichmanni
1.4. Homocysteine measured by fluorescence polarisation assay
Secondary outcome measuresMeasured at baseline and at 16 weeks:
1. Vitamin D measured as 25-hydroxyvitamin D using liquid chromatography – mass spectrometry (LC–MS)
2. Anthropometric variables: weight measured on a scale, BMI calculated, systolic and diastolic blood pressure measured using an Omron 705IT monitor
Overall study start date01/01/2017
Completion date01/01/2020

Eligibility

Participant type(s)Healthy volunteer
Age groupSenior
SexBoth
Target number of participants95
Total final enrolment95
Key inclusion criteria1. Free-living adults
2. Aged 50 years and over
3. Consumption of four or less portions of fortified food per week
4. Did not currently or had not in the previous 4 months consumed a supplement containing B vitamins
Key exclusion criteria1. Diagnosis of coeliac disease, Crohn’s disease, ulcerative colitis, liver disease (NAFLD and hepatitis) or chronic obstructive pulmonary disease
2. Medication known to interfere with B vitamin metabolism
3. Women taking hormone replacement therapy, pregnant or lactating
4. Taking part in another research
5. Unable to give informed consent to take part
Date of first enrolment29/06/2018
Date of final enrolment01/01/2019

Locations

Countries of recruitment

  • Ireland
  • Northern Ireland
  • United Kingdom

Study participating centres

University College Dublin
Belfield
Dublin 4
Dublin
D04 V1W8
Ireland
Ulster University
Cromore Road
Coleraine
BT52 1SA
United Kingdom

Sponsor information

Funders

Funder type

Government

Department of Agriculture, Food and the Marine, Ireland
Government organisation / National government
Alternative name(s)
An Roinn Talmhaíochta, Bia agus Mara, An Roinn Talmhaiochta Bia agus Mara, Department of Agriculture, Food and the Marine, agriculture_ie, Department of Agriculture, Food and the Marine (Ireland), DAFM
Location
Ireland
Department of Agriculture, Environment and Rural Affairs, UK Government
Government organisation / National government
Alternative name(s)
DAERA
Location
United Kingdom
Smartfish AS (Norway)

No information available

Results and Publications

Intention to publish date01/10/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal. No additional documents are available.
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available as the researchers do not have consent for this.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 07/12/2021 12/04/2022 Yes No

Editorial Notes

12/04/2022: Publication reference added.
27/07/2021: Trial's existence confirmed by the UCD Human Research Ethics Committee.

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