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

NCT02208622 | Completed

• 1 other identifier: 13-0398
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

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).

Conditions

Nutritional Deficiency

Keywords

Zinc absorption; Iron Absorption; Whey Protein; Mexico; Stable isotopes

Outcome Measures

Primary Outcomes (2)

• 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).

  2 days

• 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).

  2 days

Study Arms (4)

Study 1: Whey Supplement Day 1

EXPERIMENTAL

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

Dietary Supplement: Study 1: Whey Supplement Day 1

Study 1: Whey Supplement Day 2

EXPERIMENTAL

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

Dietary Supplement: Study 1: Whey Supplement Day 2

Study 2: Whey Supplement

EXPERIMENTAL

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

Dietary Supplement: Study 2: Whey Supplement

Study 2: Control

NO INTERVENTION

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

Interventions

Study 1: Whey Supplement Day 1 DIETARY_SUPPLEMENT

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

Study 1: Whey Supplement Day 1

Study 1: Whey Supplement Day 2 DIETARY_SUPPLEMENT

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

Study 1: Whey Supplement Day 2

Study 2: Whey Supplement DIETARY_SUPPLEMENT

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

Study 2: Whey Supplement

Eligibility Criteria

• Age: 2 Years - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Universidad Autonoma de Queretaro: collaborator
• International Atomic Energy Agency: collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Universidad Autonoma de Queretaro

Querétaro, Mexico

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Michael Hambidge, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 5, 2014
• Study Start: August 1, 2013
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

US (1); ME (1)