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Oxaloacetate Supplementation for Emotional PMS (OAA4PMS)

Primary Purpose

Premenstrual Syndrome (PMS)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid)
rice flour (Placebo)
Sponsored by
Terra Biological LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome (PMS)

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with Emotional Premenstrual Syndrome (PMS),
  • Women who speak English as their primary language
  • Women who understand the Human Consent Form
  • Ability to swallow capsules

Exclusion Criteria:

  • Formal diagnosis of clinical depression
  • Formal diagnosis of premenstrual dysphoric disorder (PMDD).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Experimental: Part 1 Oxaloacetate Random

    Experimental: Part 2 Oxaloacetate Second

    Arm Description

    Participants take 2 capsules Jubilance 100 mg Oxaloacetate/150 mg Ascorbic Acid blend per day during their entire menstrual cycle (approximately 28 days) or 2 capsules of 250 mg rice flour (Placebo). After one menstrual cycle, they cross-over to the other option.

    Participants take 2 capsules of 250 mg rice flour (Placebo) per day during their entire menstrual cycle (approximately 28 days). After one menstrual cycle, they cross-over to 2 capsules of Jubilance 100 mg Oxaloacetate/150 mg Ascorbic Acid blend.

    Outcomes

    Primary Outcome Measures

    Depression associated with Emotional PMS
    Depression as measured during Emotional PMS with Beck's Depression Inventory Survey, which scores depression with 26 questions rated 0 to 3. Total score ranges from 0 to 78. Higher values indicate worse depression.
    Anxiety associated with Emotional PMS
    Anxiety as measured during Emotional PMS with Generalized Anxiety Disorder Survey, which scores anxiety with 7 questions rated 0 to 3. Total score ranges from 0 to 21. Higher values indicate worse anxiety.
    Perceived Stress with Emotional PMS
    Perceived Stress as measured during Emotional PMS with Cohen's Perceived Stress Survey, which scores perceived stress with 9 questions rated 0 to 4. Total score ranges from 0 to 36. Higher values indicate worse perceived stress.
    Aggression with Emotional PMS
    Aggression as measured during Emotional PMS with Buss-Perry Aggression Scale, which scores depression with 29 questions rated 1 to 5. Total score ranges from 29 to 145. Higher values indicate worse aggression.
    Adverse Event Reporting
    Safety of oxaloacetate supplementation in Emotional PMS patients

    Secondary Outcome Measures

    Suicidal Ideation with Emotional PMS
    Suicidal Ideation as measured with a subscale of Beck's Depression Inventory, with a scale ranging from 0 to 3 in women who initially record suicidal ideation of greater than 0.

    Full Information

    First Posted
    April 6, 2018
    Last Updated
    April 20, 2018
    Sponsor
    Terra Biological LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03509714
    Brief Title
    Oxaloacetate Supplementation for Emotional PMS
    Acronym
    OAA4PMS
    Official Title
    Oxaloacetate Supplementation for Emotional PMS; Measuring Improvements in Depression, Anxiety, Perceived Stress, and Aggression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 17, 2016 (Actual)
    Primary Completion Date
    September 1, 2017 (Actual)
    Study Completion Date
    September 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Terra Biological LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Emotional Premenstrual Syndrome (PMS) affects millions of women worldwide. For Emotional PMS, including depression, anxiety, perceived stress and aggression, there are very few options. Recent observational data suggest that nutritional supplementation with oxaloacetate, a human energy metabolite, greatly reduced the symptoms of Emotional PMS. The aim of this study was to confirm these observations on the effects of oxaloacetate on Emotional PMS symptom severity within a controlled clinical trial setting.
    Detailed Description
    Oxaloacetate is an energy metabolite found in every cell of the human body. It holds a key place in the Krebs Cycle within the mitochondria, providing energy to the cells. It is also a critical early metabolite in gluconeogenesis, which provides glucose for the heart and brain during times of low glucose. It is critical to human metabolism, proper cellular function and it is central to energy production and use in the body. Oxaloacetate may affect Emotional PMS through multiple mechanisms. During PMS, there is a large increase in glucose utilization in the cerebellum of the brain in women who are affected with emotional mood swings. Oxaloacetate supplementation has been shown to support proper glucose levels in the body. Having an excess of oxaloacetate allows gluconeogenesis take place upon demand, thereby fueling the brain, and perhaps meeting cerebellum glucose need. In addition to oxaloacetate's ability to support proper glucose regulation, oxaloacetate affects two chemicals in the brain, GABA and glutamate. Altering the GABA/Glutamate ratio can affect mood. Oxaloacetate supplementation can reduce glutamate levels in the brain via a process called "Glutamate Scavenging". In addition, oxaloacetate supplementation was shown to increase GABA levels in animal models. By both lowering glutamate and increasing GABA, the GABA/Glutamate ratio is affected, which may also help women with Emotional PMS. This study will investigate oxaloacetate's effect on Emotional PMS using patient completed surveys to measure depression, anxiety, perceived stress, and aggression, and statistically compare these results against placebo (rice flour) and baseline measurements.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premenstrual Syndrome (PMS)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Baseline measurement of all participants. Randomized double-blinded placebo controlled crossover study for Phase 1. Due to carry-over effects, Phase 2 of the study started each participant with placebo.
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Oxaloacetate/Vitamin C capsules were bottled in 30 count HDPE bottles. Placebo capsules (rice flour) were manufactured to similar size capsules and bottles. Bottles were labeled either Group A or Group 1. Code was broken at the end of Phase 1 of the study.
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: Part 1 Oxaloacetate Random
    Arm Type
    Active Comparator
    Arm Description
    Participants take 2 capsules Jubilance 100 mg Oxaloacetate/150 mg Ascorbic Acid blend per day during their entire menstrual cycle (approximately 28 days) or 2 capsules of 250 mg rice flour (Placebo). After one menstrual cycle, they cross-over to the other option.
    Arm Title
    Experimental: Part 2 Oxaloacetate Second
    Arm Type
    Active Comparator
    Arm Description
    Participants take 2 capsules of 250 mg rice flour (Placebo) per day during their entire menstrual cycle (approximately 28 days). After one menstrual cycle, they cross-over to 2 capsules of Jubilance 100 mg Oxaloacetate/150 mg Ascorbic Acid blend.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid)
    Other Intervention Name(s)
    Jubilance for Emotional PMS
    Intervention Description
    2 Pills to be taken orally per day during their entire menstrual cycle
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    rice flour (Placebo)
    Intervention Description
    250 mg rice flour (Placebo)
    Primary Outcome Measure Information:
    Title
    Depression associated with Emotional PMS
    Description
    Depression as measured during Emotional PMS with Beck's Depression Inventory Survey, which scores depression with 26 questions rated 0 to 3. Total score ranges from 0 to 78. Higher values indicate worse depression.
    Time Frame
    Change from baseline value to value after supplementation for entire menstrual cycle (about 28 days) for each study arm in cross-over design (3 data points compared 1 at baseline 1 after menstrual cycle 1 and 1 after menstrual cycle 2).
    Title
    Anxiety associated with Emotional PMS
    Description
    Anxiety as measured during Emotional PMS with Generalized Anxiety Disorder Survey, which scores anxiety with 7 questions rated 0 to 3. Total score ranges from 0 to 21. Higher values indicate worse anxiety.
    Time Frame
    Change from baseline value to value after supplementation for one entire menstrual cycle (about 28 days) for each study arm in cross-over design (3 data points compared 1 at baseline 1 after menstrual cycle 1 and 1 after menstrual cycle 2).
    Title
    Perceived Stress with Emotional PMS
    Description
    Perceived Stress as measured during Emotional PMS with Cohen's Perceived Stress Survey, which scores perceived stress with 9 questions rated 0 to 4. Total score ranges from 0 to 36. Higher values indicate worse perceived stress.
    Time Frame
    Change from baseline value to value after supplementation for one entire menstrual cycle (about 28 days) for each study arm in cross-over design (3 data points compared 1 at baseline 1 after menstrual cycle 1 and 1 after menstrual cycle 2).
    Title
    Aggression with Emotional PMS
    Description
    Aggression as measured during Emotional PMS with Buss-Perry Aggression Scale, which scores depression with 29 questions rated 1 to 5. Total score ranges from 29 to 145. Higher values indicate worse aggression.
    Time Frame
    Change from baseline value to value after supplementation for one entire menstrual cycle (about 28 days) for each study arm in cross-over design (3 data points compared 1 at baseline 1 after menstrual cycle 1 and 1 after menstrual cycle 2).
    Title
    Adverse Event Reporting
    Description
    Safety of oxaloacetate supplementation in Emotional PMS patients
    Time Frame
    Through study completion, an average of 60 days (2 menstrual cycles)
    Secondary Outcome Measure Information:
    Title
    Suicidal Ideation with Emotional PMS
    Description
    Suicidal Ideation as measured with a subscale of Beck's Depression Inventory, with a scale ranging from 0 to 3 in women who initially record suicidal ideation of greater than 0.
    Time Frame
    Change from baseline value to value after supplementation for one entire menstrual cycle (about 28 days) for each study arm in cross-over design (3 data points compared 1 at baseline 1 after menstrual cycle 1 and 1 after menstrual cycle 2).

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women with Emotional Premenstrual Syndrome (PMS), Women who speak English as their primary language Women who understand the Human Consent Form Ability to swallow capsules Exclusion Criteria: Formal diagnosis of clinical depression Formal diagnosis of premenstrual dysphoric disorder (PMDD).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisa Tully, PhD
    Organizational Affiliation
    Energy Medicine research Institute
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19793063
    Citation
    Williams DS, Cash A, Hamadani L, Diemer T. Oxaloacetate supplementation increases lifespan in Caenorhabditis elegans through an AMPK/FOXO-dependent pathway. Aging Cell. 2009 Dec;8(6):765-8. doi: 10.1111/j.1474-9726.2009.00527.x. Epub 2009 Sep 30.
    Results Reference
    background
    PubMed Identifier
    4884771
    Citation
    Yoshikawa K. Studies on the anti-diabetic effect of sodium oxaloacetate. Tohoku J Exp Med. 1968 Oct;96(2):127-41. doi: 10.1620/tjem.96.127. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21092938
    Citation
    Rapkin AJ, Berman SM, Mandelkern MA, Silverman DH, Morgan M, London ED. Neuroimaging evidence of cerebellar involvement in premenstrual dysphoric disorder. Biol Psychiatry. 2011 Feb 15;69(4):374-80. doi: 10.1016/j.biopsych.2010.09.029. Epub 2010 Nov 18.
    Results Reference
    background
    PubMed Identifier
    20821056
    Citation
    Schmahmann JD. The role of the cerebellum in cognition and emotion: personal reflections since 1982 on the dysmetria of thought hypothesis, and its historical evolution from theory to therapy. Neuropsychol Rev. 2010 Sep;20(3):236-60. doi: 10.1007/s11065-010-9142-x. Epub 2010 Sep 7.
    Results Reference
    background
    PubMed Identifier
    25027327
    Citation
    Wilkins HM, Harris JL, Carl SM, E L, Lu J, Eva Selfridge J, Roy N, Hutfles L, Koppel S, Morris J, Burns JM, Michaelis ML, Michaelis EK, Brooks WM, Swerdlow RH. Oxaloacetate activates brain mitochondrial biogenesis, enhances the insulin pathway, reduces inflammation and stimulates neurogenesis. Hum Mol Genet. 2014 Dec 15;23(24):6528-41. doi: 10.1093/hmg/ddu371. Epub 2014 Jul 15.
    Results Reference
    background
    PubMed Identifier
    32206660
    Citation
    Tully L, Humiston J, Cash A. Oxaloacetate reduces emotional symptoms in premenstrual syndrome (PMS): results of a placebo-controlled, cross-over clinical trial. Obstet Gynecol Sci. 2020 Mar;63(2):195-204. doi: 10.5468/ogs.2020.63.2.195. Epub 2020 Feb 25.
    Results Reference
    derived

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    Oxaloacetate Supplementation for Emotional PMS

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