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

Primary Purpose

Nutritional Deficiency

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Study 1: Whey Supplement Day 1
Study 1: Whey Supplement Day 2
Study 2: Whey Supplement
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nutritional Deficiency focused on measuring Zinc absorption, Iron Absorption, Whey Protein, Mexico, Stable isotopes

Eligibility Criteria

2 Years - 3 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Colorado Anschutz Medical Campus
  • Universidad Autonoma de Queretaro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Study 1: Whey Supplement Day 1

Study 1: Whey Supplement Day 2

Study 2: Whey Supplement

Study 2: Control

Arm Description

Children in this arm received the whey supplement as part if their diet on day 1.

Children in this arm received whey supplement as part of their diet on day 2.

Children in this arm received a whey supplement as part of their diet.

Children in this arm did not receive a whey supplement as part of their diet.

Outcomes

Primary Outcome Measures

Zinc Absorption
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).
Iron Absorption
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).

Secondary Outcome Measures

Full Information

First Posted
August 1, 2014
Last Updated
July 1, 2019
Sponsor
University of Colorado, Denver
Collaborators
Universidad Autonoma de Queretaro, International Atomic Energy Agency
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1. Study Identification

Unique Protocol Identification Number
NCT02208622
Brief Title
Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet
Official Title
Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Universidad Autonoma de Queretaro, International Atomic Energy Agency

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Deficiency
Keywords
Zinc absorption, Iron Absorption, Whey Protein, Mexico, Stable isotopes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study 1: Whey Supplement Day 1
Arm Type
Experimental
Arm Description
Children in this arm received the whey supplement as part if their diet on day 1.
Arm Title
Study 1: Whey Supplement Day 2
Arm Type
Experimental
Arm Description
Children in this arm received whey supplement as part of their diet on day 2.
Arm Title
Study 2: Whey Supplement
Arm Type
Experimental
Arm Description
Children in this arm received a whey supplement as part of their diet.
Arm Title
Study 2: Control
Arm Type
No Intervention
Arm Description
Children in this arm did not receive a whey supplement as part of their diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
Study 1: Whey Supplement Day 1
Intervention Description
Whey supplement was given on day 1, control diet on day 2
Intervention Type
Dietary Supplement
Intervention Name(s)
Study 1: Whey Supplement Day 2
Intervention Description
Control diet was given day 1, whey supplement was given day 2
Intervention Type
Dietary Supplement
Intervention Name(s)
Study 2: Whey Supplement
Intervention Description
Whey supplement was given as part of diet for both day 1 and 2 of study
Primary Outcome Measure Information:
Title
Zinc Absorption
Description
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).
Time Frame
2 days
Title
Iron Absorption
Description
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).
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hambidge, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Universidad Autonoma de Queretaro
City
Queretaro
Country
Mexico

12. IPD Sharing Statement

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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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