Development of Dietary Supplements for Mood Symptoms in Postpartum
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 1R8
- Centre for Addiciton and Mental Health
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 18 to 45
- The subject, as reported by them, should be in a good health.
- The subject is not taking any medication.
- The subject is not taking any investigational medicinal product within 8 weeks.
- BMI 19 to 40 (kg/m2)
- Resting pulse between 45 and 100 bpm
- Systolic blood pressure between 91 and 139 mmHg (inclusive)
- Diastolic blood pressure between 51 and 90 mmHg (inclusive)
Exclusion Criteria:
- The subject has been diagnosed with any axis 1 and 2 disorders based on Structured Clinical Interview (SCID) for DSM-IV interview.
- Substance abuse disorder
- Subjects who have been smoking in the past 5 years.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Postpartum with crying spells-Full dose
Healthy women who are within the first 18 months postpartum and have crying spells but do not have major depression. The effect of the dietary supplement in reducing sadness in this group will be assessed. Intervention: Full dose dietary supplement Motherwell |
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
|
|
Eksperimentel: Day-5 postpartum - Full dose
Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the dietary supplement consumption is being done after delivery and during postpartum. Intervention: Full dose dietary supplement Motherwell |
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
|
|
Eksperimentel: Day-5 postpartum - Half dose
Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the proposed dietary supplement consumption, is being done after delivery and during postpartum. Intervention: Half dose dietary supplement Motherwell |
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
|
|
Eksperimentel: Day-5 postpartum - Quarter dose
Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the proposed dietary supplement consumption, is being done after delivery and during postpartum. Intervention: Quarter dose dietary supplement Motherwell |
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
|
|
Andet: Day-5 postpartum - Control
Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving a control supplement consumption, is being done after delivery and during postpartum. Intervention: Control protein to compare with Motherwell |
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Visual Analog Scale (VAS)
Tidsramme: Assessment will be done on day-5 postpartum or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the VAS will be administered before and after sad mood indcution and compared
|
VAS uses a 10-cm scale for participants to indicate the extent to which each of them feel happy or sad.
The change in VAS before versus after sad mood induction is the change score in VAS.
The change score on the day with active dietary supplement is compare to the change score of the subjects who have not received any supplement and have been recently recruited
|
Assessment will be done on day-5 postpartum or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the VAS will be administered before and after sad mood indcution and compared
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Profile of Mood States (POMS) Scores
Tidsramme: Assessment will be done on day-5 postpartum or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the POMS will be administered before and after sad mood indcution and compared
|
The POMS contains 65 adjectives rated by participants on a 5-point scale.
Six factors are derived that include tension, depression, anger, fatigue, vigor and confusion.
|
Assessment will be done on day-5 postpartum or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the POMS will be administered before and after sad mood indcution and compared
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jeffrey H Meyer, MD,PhD,FRCPC, Research Imaging Centre, Centre for Addiction and Mental Health
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 112/2013
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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