Protein Requirement During Lactation

NCT03218956 | Completed

• 1 other identifier: H17-00079
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Protein requirement

Outcome Measures

Primary Outcomes (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.

  8 hours

Study Arms (1)

Protein intake

EXPERIMENTAL

Dietary supplement: Protein intake

Dietary Supplement: Dietary supplement: Protein intake

Interventions

Dietary supplement: Protein intake DIETARY_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.

Protein intake

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

BC Children's Hospital Research Institute, University of British Columbia

Vancouver, British Columbia, V5Z4H4, Canada

Location

Related Links

• Abstract

Study Officials

• Rajavel Elango, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 17, 2017
• Study Start: September 30, 2017
• Primary Completion: March 16, 2020
• Study Completion: March 17, 2020
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)