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

NCT ID: NCT02208622

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2018-04-30

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).

Conditions

Nutritional Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Study 1: Whey Supplement Day 1

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

Group Type: EXPERIMENTAL

Study 1: Whey Supplement Day 1

Intervention Type: DIETARY_SUPPLEMENT

Whey supplement was given on day 1, control diet on day 2

Study 1: Whey Supplement Day 2

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

Group Type: EXPERIMENTAL

Study 1: Whey Supplement Day 2

Intervention Type: DIETARY_SUPPLEMENT

Control diet was given day 1, whey supplement was given day 2

Study 2: Whey Supplement

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

Group Type: EXPERIMENTAL

Study 2: Whey Supplement

Intervention Type: DIETARY_SUPPLEMENT

Whey supplement was given as part of diet for both day 1 and 2 of study

Study 2: Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Study 1: Whey Supplement Day 1

Whey supplement was given on day 1, control diet on day 2

Intervention Type: DIETARY_SUPPLEMENT

Study 1: Whey Supplement Day 2

Control diet was given day 1, whey supplement was given day 2

Intervention Type: DIETARY_SUPPLEMENT

Study 2: Whey Supplement

Whey supplement was given as part of diet for both day 1 and 2 of study

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Autonoma de Queretaro

OTHER

Sponsor Role: collaborator

International Atomic Energy Agency

OTHER_GOV

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Hambidge, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Universidad Autonoma de Queretaro

Querétaro, , Mexico

Countries

United States; Mexico

Other Identifiers

13-0398

Identifier Type: -

Identifier Source: org_study_id