None listed
Conditions
Brief summary
Iron deficiency and consequently iron deficiency anaemia develops when iron intake does not meet iron requirements over the long term. Iron fortification of foods is considered to be the most cost-effective intervention to combat iron deficiency. Fortification of foods can however be a challenge with problems ranging from undesirable taste issues to decreased nutrient absorption. The Riddet Institute has developed an iron fortificant known as FERRI PRO Trademark that allows the addition of iron to food products with minimal effect on sensory characteristics and product shelf-life. The purpose of this project is to evaluate the bioavailability of iron (how much iron is absorbed and utilised by the body) from a FERRI PRO Trademark fortified instant milk beverage. A stable isotope technique, based on the analysis of the incorporation of stable (non-radioactive) isotopes into red blood cells will be used to determine bioavailability. Participants will be required to consume two iron fortified milk-based beverages on two consecutive days. The two iron fortificants, FERRI PRO Trademark and ferrous sulphate will be prepared using stable iron isotopes 57Fe and 58Fe to allow us to track the incorporation of the iron into the blood cells. Blood samples will be collected at the start and 14 days after the consumption of the drinks. Analysis of these samples will tell us how much iron from each beverage has been absorbed and a comparison to be made.
Interventions
Iron absorption from isotopically Fe labelled FERRI PRO Trademark was directly compared against iron absorption from isotopically Fe labelled ferrous sulphate in a randomized cross-over study.
An instant milk drink (250 ml) containing isotopically labelled FERRI PRO Trademark (2.4 mg fortification iron per serving) was fed twice after an overnight fast with both feedings being separated by a 3 h interval. Emptied glasses were washed twice with 25 ml of milli-q water. Participants consume
Iron absorption from isotopically Fe labelled FERRI PRO Trademark was directly compared against iron absorption from isotopically Fe labelled ferrous sulphate in a randomized cross-over study. An instant milk drink (250 ml) containing isotopically labelled FERRI PRO Trademark (2.4 mg fortification iron per serving) was fed twice after an overnight fast with both feedings being separated by a 3 h interval. Emptied glasses were washed twice with 25 ml of milli-q water. Participants consumed the washings in order to ensure complete intake of the drink and the isotopically labelled fortificant. Participants were asked not to eat or drink between the two servings and for 3 h following the second administration. All feedings were performed under close supervision of the investigators. Half of the participants were fed the FERRI PRO Trademark on the first day followed by the comparator ferrous sulphate on the second day whilst the other half of the participants were fed the comparator on the first day and FERRI PRO Trademark on the second day.
Sponsors
Massey University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
19 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy, non-anaemic, non-iron deficient (serum ferritin concentrations are > 12 ug/L and < 150 ug/L; haemoglobin > 120 g/L. Stable body weight and normal body mass index (18.5-25 kg/m2). Caucasian/European descent. C-reactive protein concentrations < 5 mg/L.
Exclusion criteria
History of gastrointestinal disorders including ulcers or gastrointestinal surgery. Established health problems likely to influence iron status such as inflammatory bowel disease, endocrine disorders, diabetes, celiac disease, red blood cell disorders, menorrhagia, haemorrhoids, haematuria or have had malaria. Donated blood or had significant blood loss during the 6 months prior to the study. Participated in a study involving administration of stable isotopes. Participated in another clinical trial during the three months leading up to the start of the study. Consumed antibiotics one month before the study and/or during the study. Be anaemic Be pregnant or have been pregnant in the 12 months prior to the study. Be breastfeeding. Regular consumers of iron supplements (define as >20 mg elemental iron at least 3-4 times per week for one month prior to the trial. Smoke cigarettes. Consume more than two units of alcohol per day. Vegetarian or vegan. Allergies to dairy products. On a controlled diet or dietary weight loss regimen within 4 weeks before and/or during the study. Experienced significant weight loss during the 6 months prior to the study. Taking any medications regularly, including antacids, except oral contraceptives. Have an aversion to blood sample collection.
Outcome results
None listed