Premenstrual Syndrome (PMS) Clinical Trial
Official title:
Oxaloacetate Supplementation for Emotional PMS; Measuring Improvements in Depression, Anxiety, Perceived Stress, and Aggression
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 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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01961479 -
Treatment of Premenstrual Syndrome - Internet-based Self-help
|
N/A |