PregnancyNCT03218956
Protein Requirement During Lactation
A study testing Dietary supplement: Protein intake in people with Pregnancy, run by University of British Columbia at 1 site in Canada.
Trial summary
It is well established that a breast-feeding women need more protein in their diet compared to non-lactating women, but how much additional protein is needed remains unclear. There is reason to believe that the current Dietary Reference Intake (DRI) recommendations for breast-feeding women are too low. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Dietary supplement: Protein intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2017to 17 Mar 2020
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy lactating women
- With a healthy baby
- Exclusively breast feeding (3 - 5 months) and are partially breast-feeding women (6 - 8 months) - not supplementing with infant formula
Who cannot join
- Women below 20 yrs or above 45 yrs of age
- Women who are breast-feeding more than one child
- Women who are not exclusively breast feeding (3 - 5 months) and women who are supplementing with infant formula or have not transitioned to solid foods by 6 - 8 months.
- Women not in good health and have a metabolic, neurological, genetic, or immune disorder.
- Women who are claustrophobic (we will place a clear hood, which can easily be removed, over the participants head for approximately 20 min to measure energy expenditure).
- Women who are substance dependent (i.e. alcohol, cigarette, illicit drugs)
- Women who are allergic to eggs and egg protein
- Women who do not have a healthy baby
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital Research Institute, University of British Columbia
Vancouver, British Columbia, V5Z4H4
About this study
Official title: Determination of Dietary Protein Requirements in Healthy Women During Stages of Lactation
It is well established that a breast-feeding women need more protein in their diet compared to non-lactating women, but how much additional protein is needed remains unclear. There is reason to believe that the current Dietary Reference Intake (DRI) recommendations for breast-feeding women are too low. To gain better understanding, we plan to study healthy breast-feeding women 20 - 45 yrs, between 3 - 5 months lactation and 6 - 8 months lactation. We will use the indicator amino acid oxidation technique (IAAO), which is a modern, quick and safe research method.
Read the detailed description
Purpose:
To determine the dietary protein intake requirement in healthy lactating women during the exclusive breast-fed period (3 - 5 months lactation) and during weaning (6 - 8 months lactation).
Hypothesis:
Recent stable isotope-based research using the IAAO technique indicate that current protein intake recommendations are underestimated in adults by ~40 %, in school aged children ~75 % and pregnant women during early and late gestation by ~39 % and ~73 %, respectively.
Therefore we hypothesize that that protein requirements will be increased during both phases of lactation above that of the current recommendations
Justification:
The WHO advocates that all newborn infants are exclusively breast-fed for the first 6 months of life, followed by a period of weaning, with appropriate complementary feeds, which is recommended to continue until the child's second birthday. The period of lactation from the mother's perspective of up to 2 years for each child, represents a considerable period of adult life. Adequate protein intake during lactation is important - if a woman's dietary intake of protein is inadequate, her own lean mass will be depleted to support the growth of the infant. Currently, dietary protein intake recommendations are based on nitrogen balance studies conducted in men and recommendations for breast-feeding women are extrapolated from these studies, and there is little breast-feeding specific data.
Objectives:
To determine the protein requirements during lactation and examine whether protein needs are significantly altered during exclusive breastfeeding (~3 - 5 mo post parturition) and partial breast feeding (~6 - 8 mo post parturition).
Research design:
A minimum of 10 women will be recruited. Each mother will participate in up to 8 study days, 4 during the exclusively breast-fed period and 4 during the partial breast-fed period, for a total of 40 data points (study days) during each lactation period. We hope to retain the same women for all 8 study days to minimize data variability.
Potential participants will meet us for a preliminary assessment where we will evaluate their eligibility to participate in the study. The preliminary assessment will take approximately 1 hour during which we will examine body composition (Bioelectrical impedance, skin-fold measurements, height and weight), resting energy expenditure (by indirect calorimetry) and medical history (questionnaire). We will collect a 3 day food diary, to determine usual food intake and food preferences. Based on the 3 day food record we will prescribe a standardized diet two days prior to the study day to ensure protein intake of 1.5 g/kg/day and 1.7 x resting energy.
During each study day, the participants will randomly receive 1 of 40 test protein intakes. Each subject will participate in one study day at approximately 14, 16, 18, 20 weeks postpartum and 24, 28, 30 and 32 weeks postpartum, respectively, for a total of up to 8 study days.
The test protein intakes will be administered in an experimental diet. The study day diets will consist of 8 isocaloric and isonitrogenic meals provided hourly, each meal presenting 1/12 of the daily energy requirement. Study day diet is composed of a crystalline amino acid mixture based on the composition of egg-protein, flavored with orange Tang, orange Kool-aid crystals and corn oil.
A stable isotope tracer will be added to the 5th - 8th meal. We will measure the rate of oxidation of this tracer expired in breath (F13CO2), and flux of this tracer by its enrichment in urine.
- Conditions
- Pregnancy
- Being tested
- Dietary supplement: Protein intake
- Keywords
- Protein requirement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement: Protein intakeDietary supplement
Oral consumption of houly experimental meals. Includes 4 meals containing a mixture of free amino acids, carbohydrates from a flavored liquid, fat from corn oil and protein free cookies.
The last 4 meals will in addition contain labelled labelled 13C phenylalanine.
| Study group | Role | What they receive |
|---|---|---|
| Protein intake | Experimental | Dietary supplement: Protein intake Receives: Dietary Supplement: Dietary supplement: Protein intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
13C Phenylalanine Oxidation
Urine, breath and a single blood sample will be collected during the study to measure the rate of oxidation of 13C phenylalanine.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start30 Sep 2017
- Primary completion16 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Rajavel Elango, PhD, University of British Columbia
- Investigators
- Rajavel Elango, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218956
- Sponsor's protocol ID
- H17-00079
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2017
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Dietary Protein Requirements in Healthy Women During Stages of Lactation
- ClinicalTrials.gov ID
- NCT03218956
- Acronym / sponsor ID
- H17-00079
- Conditions
- Pregnancy
- Keywords
- Protein requirement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 17 Jul 2017 (actual)
- 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.
It is well established that a breast-feeding women need more protein in their diet compared to non-lactating women, but how much additional protein is needed remains unclear. There is reason to believe that the current Dietary Reference Intake (DRI) recommendations for breast-feeding women are too low. To gain better understanding, we plan to study healthy breast-feeding women 20 - 45 yrs, between 3 - 5 months lactation and 6 - 8 months lactation. We will use the indicator amino acid oxidation technique (IAAO), which is a modern, quick and safe research method.
Detailed description
Purpose:
To determine the dietary protein intake requirement in healthy lactating women during the exclusive breast-fed period (3 - 5 months lactation) and during weaning (6 - 8 months lactation).
Hypothesis:
Recent stable isotope-based research using the IAAO technique indicate that current protein intake recommendations are underestimated in adults by ~40 %, in school aged children ~75 % and pregnant women during early and late gestation by ~39 % and ~73 %, respectively.
Therefore we hypothesize that that protein requirements will be increased during both phases of lactation above that of the current recommendations
Justification:
The WHO advocates that all newborn infants are exclusively breast-fed for the first 6 months of life, followed by a period of weaning, with appropriate complementary feeds, which is recommended to continue until the child's second birthday. The period of lactation from the mother's perspective of up to 2 years for each child, represents a considerable period of adult life. Adequate protein intake during lactation is important - if a woman's dietary intake of protein is inadequate, her own lean mass will be depleted to support the growth of the infant. Currently, dietary protein intake recommendations are based on nitrogen balance studies conducted in men and recommendations for breast-feeding women are extrapolated from these studies, and there is little breast-feeding specific data.
Objectives:
To determine the protein requirements during lactation and examine whether protein needs are significantly altered during exclusive breastfeeding (~3 - 5 mo post parturition) and partial breast feeding (~6 - 8 mo post parturition).
Research design:
A minimum of 10 women will be recruited. Each mother will participate in up to 8 study days, 4 during the exclusively breast-fed period and 4 during the partial breast-fed period, for a total of 40 data points (study days) during each lactation period. We hope to retain the same women for all 8 study days to minimize data variability.
Potential participants will meet us for a preliminary assessment where we will evaluate their eligibility to participate in the study. The preliminary assessment will take approximately 1 hour during which we will examine body composition (Bioelectrical impedance, skin-fold measurements, height and weight), resting energy expenditure (by indirect calorimetry) and medical history (questionnaire). We will collect a 3 day food diary, to determine usual food intake and food preferences. Based on the 3 day food record we will prescribe a standardized diet two days prior to the study day to ensure protein intake of 1.5 g/kg/day and 1.7 x resting energy.
During each study day, the participants will randomly receive 1 of 40 test protein intakes. Each subject will participate in one study day at approximately 14, 16, 18, 20 weeks postpartum and 24, 28, 30 and 32 weeks postpartum, respectively, for a total of up to 8 study days.
The test protein intakes will be administered in an experimental diet. The study day diets will consist of 8 isocaloric and isonitrogenic meals provided hourly, each meal presenting 1/12 of the daily energy requirement. Study day diet is composed of a crystalline amino acid mixture based on the composition of egg-protein, flavored with orange Tang, orange Kool-aid crystals and corn oil.
A stable isotope tracer will be added to the 5th - 8th meal. We will measure the rate of oxidation of this tracer expired in breath (F13CO2), and flux of this tracer by its enrichment in urine.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protein intake | Experimental | Dietary Supplement: Dietary supplement: Protein intakeDietary supplement: Protein intake |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy lactating women
- With a healthy baby
- Exclusively breast feeding (3 - 5 months) and are partially breast-feeding women (6 - 8 months) - not supplementing with infant formula
Key exclusion criteria (8 listed)
- Women below 20 yrs or above 45 yrs of age
- Women who are breast-feeding more than one child
- Women who are not exclusively breast feeding (3 - 5 months) and women who are supplementing with infant formula or have not transitioned to solid foods by 6 - 8 months.
- Women not in good health and have a metabolic, neurological, genetic, or immune disorder.
- Women who are claustrophobic (we will place a clear hood, which can easily be removed, over the participants head for approximately 20 min to measure energy expenditure).
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 |
|---|---|---|
| Dietary supplement: Protein intakeOral consumption of houly experimental meals. Includes 4 meals containing a mixture of free amino acids, carbohydrates from a flavored liquid, fat from corn oil and protein free cookies. The last 4 meals will in addition contain labelled labelled 13C phenylalanine. | Dietary supplement | Protein intake |
Primary outcome
13C Phenylalanine Oxidation
Time frame: 8 hours
Urine, breath and a single blood sample will be collected during the study to measure the rate of oxidation of 13C phenylalanine.
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 19 Jul 2024.
- AbstractLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share data with other researchers
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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.
Rajavel Elango, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement: Protein intake in people with Pregnancy, run by University of British Columbia at 1 site in Canada.
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 3 inclusion and 8 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 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
13C Phenylalanine Oxidation (time frame: 8 hours). 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 19 Jul 2024.