Nutritional DeficiencyNCT02208622
Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet
A study testing Study 1: Whey Supplement Day 1, Study 1: Whey Supplement Day 2 and Study 2: Whey Supplement in people with Nutritional Deficiency, run by University of Colorado, Denver at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Deficiency
- What is being tested?
- Study 1: Whey Supplement Day 1, Study 1: Whey Supplement Day 2 and Study 2: Whey Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2013to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2-3 years of age
- Live in poor, rural communities
- Healthy
- Parents had provided informed consent
Who cannot join
- An acute or chronic illness which affects gut function, or
- They are breast feeding.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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).
Read the 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
- Being tested
- Study 1: Whey Supplement Day 1, Study 1: Whey Supplement Day 2, Study 2: Whey Supplement
- Keywords
- Zinc absorption, Iron Absorption, Whey Protein, Mexico, Stable isotopes
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study 1: Whey Supplement Day 1Dietary supplement
Whey supplement was given on day 1, control diet on day 2
Study 1: Whey Supplement Day 2Dietary supplement
Control diet was given day 1, whey supplement was given day 2
Study 2: Whey SupplementDietary supplement
Whey supplement was given as part of diet for both day 1 and 2 of study
| Study group | Role | What they receive |
|---|---|---|
| Study 1: Whey Supplement Day 1 | Experimental | Children in this arm received the whey supplement as part if their diet on day 1. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startAug 2013
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DeficiencyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de Queretaro, International Atomic Energy Agency
- Responsible party
- Sponsor
- Investigators
- Michael Hambidge, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208622
- Sponsor's protocol ID
- 13-0398
- Status last verified
- Jul 2019
- First submitted
- 1 Aug 2014
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet
- ClinicalTrials.gov ID
- NCT02208622
- Acronym / sponsor ID
- 13-0398
- Conditions
- Nutritional Deficiency
- Keywords
- Zinc absorption, Iron Absorption, Whey Protein, Mexico, Stable isotopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Universidad Autonoma de Queretaro, International Atomic Energy Agency
- Study start
- Aug 2013 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study 1: Whey Supplement Day 1 | Experimental | Dietary Supplement: Study 1: Whey Supplement Day 1Children in this arm received the whey supplement as part if their diet on day 1. |
| Study 1: Whey Supplement Day 2 | Experimental | Dietary Supplement: Study 1: Whey Supplement Day 2Children in this arm received whey supplement as part of their diet on day 2. |
| Study 2: Whey Supplement | Experimental | Dietary Supplement: Study 2: Whey SupplementChildren in this arm received a whey supplement as part of their diet. |
| Study 2: Control | No intervention | –Children in this arm did not receive a whey supplement as part of their diet. |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 2-3 years of age
- Live in poor, rural communities
- Healthy
- Parents had provided informed consent
Key exclusion criteria (2 listed)
- An acute or chronic illness which affects gut function, or
- They are breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study 1: Whey Supplement Day 1Whey supplement was given on day 1, control diet on day 2 | Dietary supplement | Study 1: Whey Supplement Day 1 |
| Study 1: Whey Supplement Day 2Control diet was given day 1, whey supplement was given day 2 | Dietary supplement | Study 1: Whey Supplement Day 2 |
| Study 2: Whey SupplementWhey supplement was given as part of diet for both day 1 and 2 of study | Dietary supplement | Study 2: Whey Supplement |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hambidge, MD principal investigator
University of Colorado, Denver
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study 1: Whey Supplement Day 1, Study 1: Whey Supplement Day 2 and Study 2: Whey Supplement in people with Nutritional Deficiency, run by University of Colorado, Denver at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zinc Absorption (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.