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Oxaloacetate Supplementation for Emotional PMS (OAA4PMS)

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ClinicalTrials.gov Identifier: NCT03509714
Recruitment Status : Completed
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Terra Biological LLC

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.

Condition or disease Intervention/treatment Phase
Premenstrual Syndrome (PMS) Dietary Supplement: Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid) Dietary Supplement: rice flour (Placebo) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Triple (Participant, Care Provider, Investigator)
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.
Primary Purpose: Treatment
Official Title: Oxaloacetate Supplementation for Emotional PMS; Measuring Improvements in Depression, Anxiety, Perceived Stress, and Aggression
Actual Study Start Date : October 17, 2016
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Experimental: Part 1 Oxaloacetate Random
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.
Dietary Supplement: Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid)
2 Pills to be taken orally per day during their entire menstrual cycle
Other Name: Jubilance for Emotional PMS

Dietary Supplement: rice flour (Placebo)
250 mg rice flour (Placebo)

Active Comparator: Experimental: Part 2 Oxaloacetate Second
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.
Dietary Supplement: Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid)
2 Pills to be taken orally per day during their entire menstrual cycle
Other Name: Jubilance for Emotional PMS

Dietary Supplement: rice flour (Placebo)
250 mg rice flour (Placebo)




Primary Outcome Measures :
  1. Depression associated with Emotional PMS [ 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). ]
    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.

  2. Anxiety associated with Emotional PMS [ 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). ]
    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.

  3. Perceived Stress with Emotional PMS [ 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). ]
    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.

  4. Aggression with Emotional PMS [ 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). ]
    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.

  5. Adverse Event Reporting [ Time Frame: Through study completion, an average of 60 days (2 menstrual cycles) ]
    Safety of oxaloacetate supplementation in Emotional PMS patients


Secondary Outcome Measures :
  1. Suicidal Ideation with Emotional PMS [ 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). ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509714


Sponsors and Collaborators
Terra Biological LLC
Investigators
Study Director: Lisa Tully, PhD Energy Medicine research Institute

Publications:
Responsible Party: Terra Biological LLC
ClinicalTrials.gov Identifier: NCT03509714     History of Changes
Other Study ID Numbers: EmotionalPMS1
TV-OX-108 ( Other Identifier: The Institute for Regenerative and Cellular Medicine )
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances