Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mineral Absorption From Fortified Rice Produced With Different Fortification Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572128
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : July 12, 2016
Sponsor:
Collaborators:
United Nations World Food Programme (WFP)
Global Alliance for Improved Nutrition
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Other: Fortified rice Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Comparative Evaluations of Micronutrient Absorption From Mineral Fortified Rice Produced With Different Fortification Techniques: An Evaluation of Hot and Cold Extrusion (Study 1) and Coating Technologies (Study 2)
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Minerals

Arm Intervention/treatment
Experimental: Study 1
Iron fortified rice hot or cold extruded.
Other: Fortified rice

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.


Experimental: Study 2
Iron and zinc fortified rice hot extruded or coated.
Other: Fortified rice

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.





Primary Outcome Measures :
  1. Study 1: Fractional iron absorption; [ Time Frame: 6 months ]
    Fractional iron (Study 1 and 2) absorption from different isotopically labelled meals will be calculated based on the shift of the isotope ratios in collected blood (for iron determination) samples. The iron absorption will be assessed from blood samples collected 14 or 15 days after meal administration. Iron isotope ratios will be determined by mass spectrometry. Total absorbed iron: measurement unit = mg; Fractional absorbed zinc: measurement unit = %

  2. Study 2: Additionally fractional Zinc absorption [ Time Frame: 3 months ]
    Fractional zinc (Study 2) absorption from different isotopically labelled meals will be calculated based on the shift of the isotope ratios in collected urine (for zinc determination) samples. The zinc absorption will be assessed from urine samples collected 4 days after meal administration. Zinc isotope ratios will be determined by mass spectrometry. Total absorbed zinc: measurement unit = mg; Fractional absorbed zinc: measurement unit = %


Secondary Outcome Measures :
  1. Hemoglobin [ Time Frame: 6 months ]
    The secondary outcomes in both studies are the assessment of haemoglobin, plasma ferritin and c-reactive protein in the participants. Unit: mg/l

  2. Plasma Ferritin [ Time Frame: 6 months ]
    The secondary outcomes in both studies are the assessment of haemoglobin, plasma ferritin and c-reactive protein in the participants. Unit: mg/l

  3. C- Reactive Protein [ Time Frame: 6 months ]
    The secondary outcomes in both studies are the assessment of haemoglobin, plasma ferritin and c-reactive protein in the participants. Unit: mg/l

  4. Plasma Zinc [ Time Frame: 6 months ]
    This secondary outcome will be assessed in study 2 only. Unit: mg/l



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female, 18 to 45 years old
  • Normal body Mass Index (18.5 - 25 kg/m2)
  • Body weight < 65 kg
  • Signed informed consent

Exclusion Criteria:

  • Pregnancy (assessed by a pregnancy test) or intention to become pregnant during the study
  • Lactating/ Breastfeeding
  • Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
  • Continuous/long-term use of medication during the whole study (except for contraceptives)
  • Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration and during the intervention time
  • Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months and during the intervention time
  • Earlier participation in a study using Fe or Zn stable isotopes or participation in any clinical study within the last 30 days
  • Participants who cannot be expected to comply with the study protocol (e.g. not available on certain study appointments)
  • Smoking
  • Vegan diet

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572128


Locations
Layout table for location information
Switzerland
Clinical Trials Center, University Hospital
Zurich, Switzerland, 8091
Human Nutrition Laboratory, ETH Zurich
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
United Nations World Food Programme (WFP)
Global Alliance for Improved Nutrition
Investigators
Layout table for investigator information
Principal Investigator: Michael Zimmermann, Prof. Dr. Head of Laboratory
Layout table for additonal information
Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT02572128    
Other Study ID Numbers: Rice_FeZnEC
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases