Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk

January 7, 2015 updated by: Enette Larson-Meyer, University of Wyoming

Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk

Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk Studies suggest that childbearing is an important contributor to the development of obesity in many women and that breastfeeding may be protective.

Ghrelin and peptide YY (PYY) are gut hormones involved in appetite regulation and energy homeostasis and are biological neuroendocrine signals that potentially affect body weight and adiposity/

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk.

This study evaluated whether fasting or postprandial ghrelin or PYY is different between lactating and nonlactating postpartum women matched for age, body weight, and adiposity.

Eligibility Criteria: Healthy females, 18+ years old, non-smokers, no major food allergies, first-time mom, currently pregnant or within 1 month of giving birth.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wyoming
      • Laramie, Wyoming, United States, 82071
        • Nutritional and Exercise Lab University of Wyoming

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy women (non-smokers) at least 18 years old who did not have any pregnancy complications, and gave birth to their first child within one month.
  • The study is open to women who are breastfeeding or formula feeding.

Exclusion Criteria:

  • Smoker,
  • had twins or triples,
  • had any major complication of pregnancy(example,
  • gestational diabetes);
  • have kidney, liver, hormonal, stomach, intestine,lung, heart or blood disease. This also includes high blood pressure;
  • use prescription or over-the-counter medicine or herbal drinks or pills.
  • History of depression, anxiety, disordered eating, other psychological problems, alcoholism or other substance abuse.
  • Severely claustrophobic.
  • Having a strong fear of needles and/or do not feel you can have blood drawn every 30 minutes from a plastic catheter.
  • Are not able to or willing to fully participate in the study, and are pregnant, anemic or have a thyroid problem.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Four weeks Postpartum Lactating
women between 18 and 45 who delivered their first child 4 weeks prior and who were currently lactating and planning to lactate for one year postpartum.
Monitoring two recently discovered appetite hormones called "ghrelin" and "neuropeptide YY (PYY)." This study evaluated whether fasting or postprandial ghrelin or PYY is different btween lactating and nonlactating postpartum women matched for age, body weight, and adiposity.
Other: Control Never Pregnant
women between 18 and 45 who have never been pregnant
Monitoring two recently discovered appetite hormones called "ghrelin" and "neuropeptide YY (PYY)." This study evaluated whether fasting or postprandial ghrelin or PYY is different btween lactating and nonlactating postpartum women matched for age, body weight, and adiposity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk"
Time Frame: 5 years
Biomedical Research Study that will provide information on reducing maternal obesity.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dawine E. Larson-Meyer, Phd, RD, University of Wyoming

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (Estimate)

January 23, 2012

Study Record Updates

Last Update Posted (Estimate)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • P20RR016474 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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