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.

Oxaloacetate Supplementation for Emotional PMS

Premenstrual Syndrome (PMS)

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.

Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid)

rice flour (Placebo)

Oxaloacetate Supplementation for Emotional PMS; Measuring Improvements in Depression, Anxiety, Perceived Stress, and Aggression

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 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 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 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.

Safety of oxaloacetate supplementation in Emotional PMS patients

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.

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.

Oxaloacetate Supplementation for Emotional PMS

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?