- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01514539
Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk
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
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wyoming
-
Laramie, Wyoming, United States, 82071
- Nutritional and Exercise Lab University of Wyoming
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Dawine E. Larson-Meyer, Phd, RD, University of Wyoming
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P20RR016474 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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