Oxaloacetate Supplementation for Emotional PMS
Condition: Premenstrual Syndrome (PMS)
MeSH terms: Premenstrual Syndrome
Study type: Interventional

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.
    

Intervention name(s): Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid); rice flour (Placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 Pills to be taken orally per day during their entire menstrual cycle; 250 mg rice flour (Placebo)
Other intervention name(s): Jubilance for Emotional PMS
Intervention MeSH terms: Ascorbic Acid
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)
Primary purpose: Treatment