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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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 groups in NCT03218956
Study groupRoleWhat they receive
Protein intakeExperimentalDietary 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.

  1. 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.

  1. First posted17 Jul 2017
  2. Study start30 Sep 2017
  3. Primary completion16 Mar 2020
  4. Study completion17 Mar 2020

Resources

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)
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

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.

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