Oxaloacetate Supplementation for Emotional PMS (OAA4PMS)

Terra Biological

Status: Completed

Conditions: Premenstrual Syndrome (PMS)

Treatments: Dietary Supplement: rice flour (Placebo); Dietary Supplement: Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03509714

TV-OX-108 (Other Identifier)

EmotionalPMS1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

Experimental: Part 1 Oxaloacetate Random

Active Comparator group

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.

Treatment:

Dietary Supplement: Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid)

Dietary Supplement: rice flour (Placebo)

Experimental: Part 2 Oxaloacetate Second

Active Comparator group

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.

Treatment:

Dietary Supplement: Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid)

Dietary Supplement: rice flour (Placebo)