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Sheffield University Breakfast Study (SUBS): To determine the effectiveness of eating a fortified breakfast cereal in improving micronutrient status in adolescent girls

Randomised controlled trial of the effectiveness of a fortified breakfast cereal in improving micronutrient status in adolescent girls

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55141306
Enrollment
72
Registered
2014-01-30
Start date
2012-07-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Micronutrient status in adolescent girls, breakfast cereal consumption Nutritional, Metabolic, Endocrine

Interventions

Girls are randomised to receive a daily intake of either fortified or unfortified cereal (50 g) with semi-skimmed milk (150 ml) for 12 weeks. Half of the girls are instructed to consume their cereal a

Sponsors

University of Sheffield (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female 2. Aged between 16 and 19 years 3. Skips breakfast on a regular basis 4. Healthy 5. Screening riboflavin status as measured by the erythrocyte glutathione reductase coefficient assay (EGRAC) of >1.4 and a haemoglobin level between 11.5 and 13.7g/L

Exclusion criteria

Exclusion criteria: 1. Blood donation within the last 3 months 2. Taking multivitamin or iron supplements 3. Pregnant or breastfeeding 4. Allergic to wheat, barley or milk

Design outcomes

Primary

MeasureTime frame
Dietary intake: the 4-day diet diaries will be used to assess changes in micronutrient intakes and dietary patterns during the study. Nutritional status: the following biomarkers of micronutrient status will be measured at baseline and midway at 6 weeks: 1. Riboflavin status, as the erythrocyte glutathione reductase activation coefficient 2. Folate status, as plasma 5-methyltetrahydrofolate (5-MeTHF) 3. Vitamin B-12 status as plasma holotranscobalamin 4. Vitamin D status as plasma 25-OH vitamin D 5. Full blood count, including haemoglobin (Hb), packed cell volume (PCV), mean cell volume (MCV), mean cell haemoglobin (MCH) and red blood cell numbers 6. Plasma ferritin

Secondary

MeasureTime frame
1. Height and weight are measured at the beginning and end of the study to calculate BMI measured at baseline and at the end (12 weeks) 2. Modulating effect of the time of consumption of cereal will also be examined by looking at the data from the point of view of timing of the cereal consumption

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026