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Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet

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ClinicalTrials.gov Identifier: NCT02208622
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : July 3, 2019
Sponsor:
Collaborators:
Universidad Autonoma de Queretaro
International Atomic Energy Agency
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Bioavailability of iron and zinc from habitual plant-based diets consumed by young children in Mexico is low due to the high phytate content. Whey protein has been found to increase zinc absorption, thus, providing a whey based supplement with micronutrients may be an effective strategy to increase iron and zinc bioavailability from plant-based foods and alleviate iron and zinc deficiencies. The investigators compared absorption of zinc and iron in children receiving diets with and without whey protein supplements (WPS).

Condition or disease Intervention/treatment Phase
Nutritional Deficiency Dietary Supplement: Study 1: Whey Supplement Day 1 Dietary Supplement: Study 1: Whey Supplement Day 2 Dietary Supplement: Study 2: Whey Supplement Not Applicable

Detailed Description:

Study 1: Zinc absorption studies The zinc study employed a 2-day cross-over design, labeling the WPS diet with a different zinc stable isotope (67Zn) than the control diet (70Zn). All meals during the 2-day period were labeled with tracer. The dual isotope ratio technique was used with a 3rd Zn stable isotope (68Zn) given intravenously and urine enrichment of all isotopes measured on Study Days 6-9 to measure fractional absorption of Zn (FAZ). The amount of Zn absorbed for the day was determined by multiplying the Zn intake for the day (determined from lab analyses of duplicate test meals) by the FAZ. Children (n=16) were randomized as to the order in which they consume the test and control meals on Study Day 1 and 2.

Study 2: Iron absorption studies The iron study was a cross sectional study with one group receiving control meals and the second group receiving the same control meal plus WPS. Iron absorption was measured using the erythrocyte iron incorporation technique with labeling of all meals over 2 days (58Fe). This was preceded by a reference dose of Fe57 and ascorbate on the previous day. Children (n=32) were randomized to receive the control diet or intervention diet (control diet + WPS).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet
Actual Study Start Date : August 2013
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study 1: Whey Supplement Day 1
Children in this arm received the whey supplement as part if their diet on day 1.
Dietary Supplement: Study 1: Whey Supplement Day 1
Whey supplement was given on day 1, control diet on day 2

Experimental: Study 1: Whey Supplement Day 2
Children in this arm received whey supplement as part of their diet on day 2.
Dietary Supplement: Study 1: Whey Supplement Day 2
Control diet was given day 1, whey supplement was given day 2

Experimental: Study 2: Whey Supplement
Children in this arm received a whey supplement as part of their diet.
Dietary Supplement: Study 2: Whey Supplement
Whey supplement was given as part of diet for both day 1 and 2 of study

No Intervention: Study 2: Control
Children in this arm did not receive a whey supplement as part of their diet.



Primary Outcome Measures :
  1. Zinc Absorption [ Time Frame: 2 days ]
    Absorption of zinc was compared in young children when given a habitual diet with and without a whey protein supplement. Fractional absorption of zinc for a day was measured by extrinsic labeling with stable isotopes of zinc. Fractional absorption of zinc was measured by a dual isotope tracer ratio technique. Measurement of total zinc in duplicate diets on test day will allow determination of quantity of this micronutrient absorbed (mg/d).

  2. Iron Absorption [ Time Frame: 2 days ]
    Absorption of iron was compared in young children when given a habitual diet with and without a whey protein supplement. Fractional absorption of iron for two days was measured by extrinsic labeling with stable isotopes of iron and measuring erythrocyte enrichment. Measurement of total iron in duplicate diets on test days will allow determination of quantity of this micronutrient absorbed (mg/d).



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Ages Eligible for Study:   2 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 2-3 years of age
  • Live in poor, rural communities
  • Healthy
  • Parents had provided informed consent

Exclusion Criteria:

  • An acute or chronic illness which affects gut function, or
  • They are breast feeding.

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): NCT02208622


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Mexico
Universidad Autonoma de Queretaro
Queretaro, Mexico
Sponsors and Collaborators
University of Colorado, Denver
Universidad Autonoma de Queretaro
International Atomic Energy Agency
Investigators
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Principal Investigator: Michael Hambidge, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02208622     History of Changes
Other Study ID Numbers: 13-0398
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019

Keywords provided by University of Colorado, Denver:
Zinc absorption
Iron Absorption
Whey Protein
Mexico
Stable isotopes

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders