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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Nutritional Deficiency

Treatments: Dietary Supplement: Study 1: Whey Supplement Day 2; Dietary Supplement: Study 2: Whey Supplement; Dietary Supplement: Study 1: Whey Supplement Day 1

Study type: Interventional

Funder types: Other

Identifiers

NCT02208622

13-0398

Details and patient eligibility

About

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).

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 2 to 3 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 4 patient groups

Study 1: Whey Supplement Day 1

Experimental group

Description:

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

Treatment:

Dietary Supplement: Study 1: Whey Supplement Day 1

Study 1: Whey Supplement Day 2

Experimental group

Description:

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

Treatment:

Dietary Supplement: Study 1: Whey Supplement Day 2

Study 2: Whey Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Study 2: Whey Supplement

Study 2: Control

No Intervention group

Description:

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