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

This study is currently recruiting participants.
Verified January 2012 by University of Wyoming
Sponsor:
Information provided by (Responsible Party):
Enette Larson-Meyer, University of Wyoming
ClinicalTrials.gov Identifier:
NCT01514539
First received: January 9, 2012
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Maternal Obesity Syndrome
 Behavioral: Behavioral
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wyoming:

Primary Outcome Measures:
  • "Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk" [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Biomedical Research Study that will provide information on reducing maternal obesity.


Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Four months Postpartum Lactating Behavioral: Behavioral
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.
No Intervention: Four months Postpartum Non-lactating Behavioral: Behavioral
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.
No Intervention: Control Never Pregnant Behavioral: Behavioral
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514539

Locations
United States, Wyoming
Nutritional and Exercise Lab University of Wyoming Recruiting
Laramie, Wyoming, United States, 82071
Contact: Enette Larson-Meyer, PhD     307-766-4378     enette@uwyo.edu    
Contact: Brenda Alexander, PhD     (307) 766-6278     balex@uwyo.edu    
Sponsors and Collaborators
University of Wyoming
Investigators
Principal Investigator: Dawine E. Larson-Meyer, Phd, RD University of Wyoming
  More Information

No publications provided

Responsible Party: Enette Larson-Meyer, Phd, RD, FACSM, University of Wyoming
ClinicalTrials.gov Identifier: NCT01514539     History of Changes
Other Study ID Numbers: P20RR016474
Study First Received: January 9, 2012
Last Updated: January 18, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013