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

Effectiveness of a fortified drink at improving B vitamin biomarkers in older adults: a controlled intervention trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61709781
Enrollment
95
Registered
2021-07-28
Start date
2018-06-29
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving B vitamin biomarkers Nutritional, Metabolic, Endocrine

Interventions

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 m

Sponsors

University College Dublin
Lead Sponsor
University of Ulster
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Ireland, Northern Ireland, United Kingdom

Contacts

Public ContactLorraine Brennan
lorraine.brennan@ucd.ie+353 (0)17166815

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026