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Protein Requirement During Lactation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03218956
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : October 26, 2017
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Rajavel Elango, PhD, University of British Columbia

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: Dietary supplement: Protein intake Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Determination of Dietary Protein Requirements in Healthy Women During Stages of Lactation
Actual Study Start Date : September 30, 2017
Estimated Primary Completion Date : May 15, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Protein intake
Dietary supplement: Protein intake
Dietary Supplement: Dietary supplement: Protein intake

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03218956

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Contact: Rajavel Elango, PhD 604 875 2000 ext 4911
Contact: Betina Rasmussen, MSc 604 875 2000 ext 4607

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Canada, British Columbia
BC Children's Hospital Research Institute, University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z4H4
Contact: Rajavel Elango, PhD    604 ext 4911   
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Rajavel Elango, PhD University of British Columbia

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Responsible Party: Rajavel Elango, PhD, Principal investigator, University of British Columbia Identifier: NCT03218956     History of Changes
Other Study ID Numbers: H17-00079
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rajavel Elango, PhD, University of British Columbia:
Protein requirement