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
|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|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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).
- 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).
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
|United States, Colorado|
|University of Colorado Anschutz Medical Campus|
|Aurora, Colorado, United States, 80045|
|Universidad Autonoma de Queretaro|
|Principal Investigator:||Michael Hambidge, MD||University of Colorado, Denver|