- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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/
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Wyoming
-
Laramie, Wyoming, Forente stater, 82071
- Nutritional and Exercise Lab University of Wyoming
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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.
|
|
Annen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
"Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk"
Tidsramme: 5 years
|
Biomedical Research Study that will provide information on reducing maternal obesity.
|
5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Dawine E. Larson-Meyer, Phd, RD, University of Wyoming
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P20RR016474 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .