A Dietary Supplement for Mood Symptoms in Early Postpartum: A Double Blind Randomized Placebo Controlled Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood in postpartum as compared to placebo.

Detailed Description
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This double blind placebo controlled randomized trial will evaluate the effect of administration of a dietary supplement (DS) on the intensity of postpartum blues. It is expected that the administration will result in less sadness in day-5 postpartum women after negative mood induction in those receiving the dietary supplement compared to placebo.

Official Title
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A Dietary Supplement for Mood Symptoms in Early Postpartum: A Double Blind Randomized Placebo Controlled Trial

Conditions
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Postpartum Blues, Healthy

Intervention / Treatment
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* Dietary Supplement: Motherwell
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 45 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) Orthostatic blood pressure change <20 mmHg (based on the difference between supine and standing (1 minute) systolic blood pressure) Exclusion Criteria: The subject has been diagnosed with any axis 1 and 2 disorders based on Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) interview within the past 10 years. Subjects who have been smoking cigarettes in the past 5 years (to reduce variability in mood attributable to cigarette withdrawal and monoamine oxidase A (MAO-A)). Intolerance to any of the components of the intervention. If in the principal investigator's judgement the obstetric or neonatal complications were so severe that would cause change in the results of the study, such as infant death, the subject will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: one arm receives Motherwell and one arm receives placebo; randomized double blind The supplement is expected to prevent depressed mood induction during postpartum blues whereas the placebo is not. The effect of depressed mood induction is strong during postpartum blues in 75% to 95% of mothers (who do not take Motherwell). The supplement is the intervention.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Day-5 postpartum - Active dietary supplement<br>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 | Dietary Supplement: Motherwell<br>* The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in day-5 postpartum women.<br>|
| Placebo Comparator: Day-5 postpartum - Placebo<br>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: Placebo | Other: Placebo<br>* Matching placebo for appearance, taste<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) | 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 received placebo | Assessment will be done on day-5 postpartum. On the assessment day, the VAS will be administered before and after sad mood induction and compared] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Profile of Mood States (POMS) Scores | 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. On the assessment day, the POMS will be administered before and after sad mood induction and compared] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum, Dietary Supplement, Mood Symptoms