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 ID	0000-0002-7711-7499
Phone	+353 (0)17166815
Email	lorraine.brennan@ucd.ie

Study information

Study design	Double-blind randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Home
Study type	Other
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Effectiveness of a fortified drink at improving B vitamin biomarkers in older adults: a controlled intervention trial
Study acronym	Opti-Age
Study objectives	A 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) studied	Improving B vitamin biomarkers
Intervention	Participants 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 type	Supplement
Primary outcome measure	1. 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 measures	Measured 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 date	01/01/2017
Completion date	01/01/2020

Eligibility

Participant type(s)	Healthy volunteer
Age group	Senior
Sex	Both
Target number of participants	95
Total final enrolment	95
Key inclusion criteria	1. 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 criteria	1. 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 enrolment	29/06/2018
Date of final enrolment	01/01/2019

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

University College Dublin
University/education

Belfield
Dublin 4
Dublin
D04 V1W8
Ireland

Phone	+353 (0)1 7166700
Email	rfo@ucd.ie
Website	http://www.ucd.ie/
"ROR"	https://ror.org/05m7pjf47

University of Ulster
University/education

Cromore Road
Coleraine
BT52 1SA
Northern Ireland
United Kingdom

Phone	+44 (0)28 7012 3039
Email	hisu@ulster.ac.uk
Website	http://www.ulster.ac.uk/
"ROR"	https://ror.org/01yp9g959

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 date	01/10/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal. No additional documents are available.
IPD sharing plan	The 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.