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

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ClinicalTrials.gov Identifier: NCT01514539
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
Enette Larson-Meyer, University of Wyoming

Brief Summary:

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/


Condition or disease Intervention/treatment
Maternal Obesity Syndrome Other: cross-sectional

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  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk
Study Start Date : August 2009
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Other: cross-sectional
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.
Control Never Pregnant
women between 18 and 45 who have never been pregnant
Other: cross-sectional
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.



Primary Outcome Measures :
  1. "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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT01514539


Locations
United States, Wyoming
Nutritional and Exercise Lab University of Wyoming
Laramie, Wyoming, United States, 82071
Sponsors and Collaborators
University of Wyoming
Investigators
Principal Investigator: Dawine E. Larson-Meyer, Phd, RD University of Wyoming

Responsible Party: Enette Larson-Meyer, Phd, RD, FACSM, University of Wyoming
ClinicalTrials.gov Identifier: NCT01514539     History of Changes
Other Study ID Numbers: P20RR016474 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Enette Larson-Meyer, University of Wyoming:
Human milk, Ghrelin,PYY and maternal obesity.

Additional relevant MeSH terms:
Hyperphagia
Prader-Willi Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders