Mineral Absorption From Fortified Rice Produced With Different Fortification Techniques
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The investigators studies will compare iron, respectively iron and zinc bioavailability from
      fortified rice produced from different fortification techniques using stable isotopic labels.
      Study 1 aims to compare the iron bioavailability from hot and cold extruded rice, in Study 2
      the iron and zinc bioavailability from rice using one coating technique and hot extrusion
      will be compared.
    

Detailed description: 
      Both studies will have a randomized single-blind, cross-over design. Study 1 will be
      conducted at the Institute for Nutrition and Health (IFNH), Swiss Federal Institute of
      Technology (ETH) Zurich exclusively; Study 2 will be conducted partly at Clinical Trials
      Center (CTC) Zurich and at Institute for Nutrition and Health (IFNH).

      Study 1: From an initial screening of interested candidates, the investigators will include
      20 participants to participate in the study. The participants will consume two different test
      meals containing 48g regular Basmati rice and 2g fortified rice with a vegetable sauce (in a
      random order as defined in the study plan). The meals will be based on fortified rice
      fortified with 57FePP, ZnO and a micronutrient mix, produced with hot (meal A) or cold (meal
      B) extrusion. The micronutrient mix will contain per served meal 170 µg Folic acid, 1.3 µg
      vitamin B12, 0.195 mg Vitamin A, 0.65 mg thiamin, 9.1 mg niacin, 0.78 mg vitamin B6 (17) as
      well as 1,26 mg citric acid and 36,16 mg trisodium-citrate serving as an enhancer for iron
      absorption. Randomization will include the random order of test meal A and B. Stable iron
      isotopes will be incorporated in the fortified rice.

      The whole study duration from the screening to the last contact with the participant will be
      about 1 month (36 days, including screening). At screening, on the days of test meal
      administration and at the study endpoint visit, the participants will spend about 30 minutes
      at the IFNH in the morning (0700 - 0900h).

      Study 2: From an initial screening of interested candidates, 24 non-pregnant non-lactating
      women will be recruited. The participants will be randomly assigned to one of 3 cohorts (1,
      2, 3). The only differences between the cohorts will be the time of study-start and the time
      of reference meal administration. The participants will consume two different test meals (in
      a random order as defined in the study plan) and one reference meal. The meals will be based
      on rice fortified with stable isotopes of iron (57FePP) and zinc (67ZnO) as well as a
      micronutrient mix, produced with coated rice from Wright Enrichment Inc. (meal A) or hot
      extruded rice produced at ETH Zurich (meal B). The reference meal (meal C) will consist of
      extruded rice with the micronutrient mix only (with no extra added iron or zinc) and regular
      rice where a 58FeSO4 (Ferrous Sulfate) solution is added prior to consumption. Randomization
      will include the random order of test meals A and B. Meal C will be given one day before the
      first (cohort 1) or second (cohort 2) test meal. Additionally, stable zinc isotopes will be
      given to the subjects intravenously.

      The whole study duration from the screening to the last contact with the participant will be
      about 2 months (51 days including screening). At screening and on the days of test meal
      administration, the participants will spend about 20 - 30 minutes at the IFNH or at the CTC
      in the morning (0700 - 0900h).

      For both studies, the blood samples will be used for determining iron bioavailability. In
      Study 2, additional urine samples will be collected for determining the zinc bioavailability.
      The baseline blood and urine samples and the blood samples collected 14 days (Study 1),
      respectively 15 days (Study 2), after test meal administration as well as the urine samples
      collected 4 days (96 hours) after test meal administration will be analyzed by inductively
      coupled plasma mass spectrometry (ICP-MS) for isotope enrichment, and fractional as well as
      absolute Fe and Zn absorption will be calculated for each test meal in each subject.
    

Intervention name(s): Fortified rice
Intervention type(s): Other
Intervention description(s): Study 1: Hot or cold extruded rice fortified test meals fortified with Ferric Pyrophosphate and Zinc oxide will be administered - subjects serve as their own controls.
Study 2: Hot extruded rice or coated rice fortified with Ferric Pyrophosphate and Zinc Oxide will be administered.
Regular rice fortified with Ferrous Sulfate (FeSO4) will act as a control in study 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science