Back to resultsHormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk
Primary Purpose
Maternal Obesity Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cross-sectional
Sponsored by
About this trial
This is an interventional prevention trial for Maternal Obesity Syndrome focused on measuring Human milk, Ghrelin,PYY and maternal obesity.
Eligibility 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.
Sites / Locations
- Nutritional and Exercise Lab University of Wyoming
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Four weeks Postpartum Lactating
Control Never Pregnant
Arm Description
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.
women between 18 and 45 who have never been pregnant
Outcomes
Primary Outcome Measures
"Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk"
Biomedical Research Study that will provide information on reducing maternal obesity.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01514539
Brief Title
Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk
Official Title
Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wyoming
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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/
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Obesity Syndrome
Keywords
Human milk, Ghrelin,PYY and maternal obesity.
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Four weeks Postpartum Lactating
Arm Type
Other
Arm Description
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.
Arm Title
Control Never Pregnant
Arm Type
Other
Arm Description
women between 18 and 45 who have never been pregnant
Intervention Type
Other
Intervention Name(s)
cross-sectional
Intervention Description
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 Measure Information:
Title
"Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk"
Description
Biomedical Research Study that will provide information on reducing maternal obesity.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawine E. Larson-Meyer, Phd, RD
Organizational Affiliation
University of Wyoming
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutritional and Exercise Lab University of Wyoming
City
Laramie
State/Province
Wyoming
ZIP/Postal Code
82071
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk
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