This trial is active, not recruiting.

Condition nutritional deficiency
Treatments study 1: whey supplement day 1, study 1: whey supplement day 2, study 2: whey supplement
Sponsor University of Colorado, Denver
Collaborator Universidad Autonoma de Queretaro
Start date August 2013
End date December 2013
Trial size 50 participants
Trial identifier NCT02208622, 13-0398


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Children in this arm received the whey supplement as part if their diet on day 1.
study 1: whey supplement day 1
Whey supplement was given on day 1, control diet on day 2
Children in this arm received whey supplement as part of their diet on day 2.
study 1: whey supplement day 2
Control diet was given day 1, whey supplement was given day 2
Children in this arm received a whey supplement as part of their diet.
study 2: whey supplement
Whey supplement was given as part of diet for both day 1 and 2 of study
(No Intervention)
Children in this arm did not receive a whey supplement as part of their diet.

Primary Outcomes

Zinc Absorption
time frame: 2 days
Iron Absorption
time frame: 2 days

Eligibility Criteria

Male or female participants from 2 years up to 3 years old.

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.

Additional Information

Official title Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet
Principal investigator Michael Hambidge, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.