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Oxaloacetate CFS – A Medical Food for the Treatment of ME/CFS

Oxaloacetate CFS – A Medical Food for the Treatment of ME/CFS

A Medical Food For Chronic Fatigue Syndrome 1,500% More Oxaloacetate than benaGene

Clinically Proven to Significantly Reduce Fatigue in ME/CFS Patients
Anhydrous Enol-Oxaloacetate (AEO), 500 mg Capsules in a 90-count Bottle

  • Clinically proven to significantly lower fatigue in the latest ME/CFS study published by Springer Nature’s Journal of Translational Medicine.

    • Up to 33% reduction in fatigue for Chronic Fatigue Syndrome patients in 6 weeks
    • Up to 47% reduction in fatigue for Long COVID patients that meet ME/CFS criteria in 6 weeks

Oxaloacetate CFS (AEO) is used to lower fatigue by patients in 20+ countries worldwide.

  • “It’s improved my son’s life one thousand percent.”
  • “[Taking Oxaloacetate CFS] felt like waking up… The fact that I am able to entertain myself and work, brings a quality of life that I wasn't able to have before.”

FDA Submitted Structure/Function Claim

“Oxaloacetate may help alleviate physical and mental fatigue symptoms associated with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)”

Oxaloacetate CFS (AEO) is manufactured to the highest quality standards, in the United States, in cGMP facilities. Zero fillers, additives, dyes or flow agents. 

 

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Description

This product is a “Medical Food” formulated to be consumed under the supervision of a health care professional for the specific dietary management of Chronic Fatigue Syndrome (ME/CFS).

Each capsule contains 500 mg anhydrous enol-oxaloacetate housed inside a vegetarian capsule. Capsules should be taken with a meal. Our product is physician quality, safe and non-toxic, keto-friendly, gluten-free, and hormone-free.

All of our products are manufactured in state-of-the-art GMP facilities.

90 Capsules per bottle:

  • 500 mg Oxaloacetate (Anhydrous Enol-Oxaloacetate)
  • Vegetarian Capsule
  • No Fillers, No Flow Agents, No Dyes, No Gluten, and No Preservatives.

Study Results

SAN DIEGO, June 29, 2022 — A new study reports significantly reduced mental and physical fatigue in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long COVID patients, with the administration of oral Anhydrous Enol-Oxaloacetate, (AEO), a medical food and nutritional supplement.

The study reports that six weeks of oxaloacetate treatment resulted in,

  • Reduction of fatigue in Long COVID patients by up to 46.8%
  • Reduction of fatigue in ME/CFS patients by an average of 22.5% to 33%

The controlled clinical trial, using a dose escalating methodology, utilized ME/CFS patients who had been diagnosed for an average of 8.9 years and Long COVID patients with symptoms for at least 6 months.

ME/CFS patients were given oxaloacetate doses of either 500 milligrams twice per day, 1,000 milligrams twice per day or 1,000 milligrams three times per day. Reduction in fatigue was dose dependent, with the smallest dose yielding a 21.7% reduction in fatigue and the largest yielding a 33.3% reduction in six weeks. Long COVID patients were given either 500 milligrams twice per day or 1000 milligrams of oxaloacetate twice per day, with fatigue reduced by up to 46.8% in six weeks.

“This data is showing oral oxaloacetate treatment may play a key role in moving dysfunctional metabolic changes back towards normal functioning,” says David Lyons Kaufman, MD, study coauthor and founder of the Center for Complex Diseases.  “We certainly owe it to ME/CFS patients to give this treatment more investigation.”

Oxaloacetate, a human energy metabolite, is present in nearly every cell of the human body. Metabolomic studies in ME/CFS patients vs. normal controls indicate that oxaloacetate levels are significantly reduced in the plasma of ME/CFS patients.

“For the millions of people worldwide struggling to live with chronic fatigue, this is really hopeful news,” says Alan Cash, coauthor of the study published by the Journal of Translational Medicine, a Springer/Nature publication. “Amelioration of fatigue to this degree may be life changing. This could look like the difference between being stuck in bed for months and being able to get back to work, attending a wedding, and enjoying life again.”

The complete peer-reviewed clinical trial results are made available by the Journal of Translational Medicine.

Oxaloacetate Treatment For Mental And Physical Fatigue In Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long-COVID fatigue patients: a non-randomized controlled clinical trial

Abstract

Background

There is no approved pharmaceutical intervention for Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS). Fatigue in these patients can last for decades. Long COVID may continue to ME/CFS, and currently, it is estimated that up to 20 million Americans have significant symptoms after COVID, and the most common symptom is fatigue. Anhydrous Enol-Oxaloacetate, (AEO) a nutritional supplement, has been anecdotally reported to relieve physical and mental fatigue and is dimished in ME/CFS patients. Here, we examine the use of higher dosage AEO as a medical food to relieve pathological fatigue.

Methods

ME/CFS and Long-COVID patients were enrolled in an open label dose escalating “Proof of Concept” non-randomized controlled clinical trial with 500 mg AEO capsules. Control was provided by a historical ME/CFS fatigue trial and supporting meta-analysis study, which showed average improvement with oral placebo using the Chalder Scale of 5.9% improvement from baseline. At baseline, 73.7% of the ME/CFS patients were women, average age was 47 and length of ME/CFS from diagnosis was 8.9 years. The Long-COVID patients were a random group that responded to social media advertising (Face Book) with symptoms for at least 6 months. ME/CFS patients were given separate doses of 500 mg BID (N = 23), 1,000 mg BID (N = 29) and 1000 mg TID (N = 24) AEO for six weeks. Long COVID patients were given 500 mg AEO BID (N = 22) and 1000 mg AEO (N = 21), again over a six-week period. The main outcome measure was to compare baseline scoring with results at 6 weeks with the Chalder Fatigue Score (Likert Scoring) versus historical placebo. The hypothesis being tested was formulated prior to data collection.

Results

76 ME/CFS patients (73.7% women, median age of 47) showed an average reduction in fatigue at 6 weeks as measured by the “Chalder Fatigue Questionnaire” of 22.5% to 27.9% from baseline (P < 0.005) (Likert scoring). Both physical and mental fatigue were significantly improved over baseline and historical placebo. Fatigue amelioration in ME/CFS patients increased in a dose dependent manner from 21.7% for 500 mg BID to 27.6% for 1000 mg Oxaloacetate BID to 33.3% for 1000 mg TID. Long COVID patients’ fatigue was significantly reduced by up to 46.8% in 6-weeks.

Conclusions

Significant reductions in physical and metal fatigue for ME/CFS and Long-COVID patients were seen after 6 weeks of treatment. As there has been little progress in providing fatigue relief for the millions of ME/CFS and Long COVID patients, anhydrous enol oxaloacetate may bridge this important medical need. Further study of oxaloacetate supplementation for the treatment of ME/CFS and Long COVID is warranted.

Graphical Abstract

1,000 mg BID Normalized Fatigue Data for Baseline, 2-weeks and 6-weeks evaluated by 3 Validated Fatigue Scoring Questionnaires

Key points

Question: Can normalization of metabolism with oxaloacetate help reduce fatigue in ME/CFS and Long COVID?

Findings: Patients with ME/CFS and Long-COVID treated with oral Anhydrous Enol-Oxaloacetate capsules achieved highly significant reductions in physical and mental fatigue within 6 weeks.

Meaning: Pathological Fatigue is an unmet medical problem pervasive in ME/CFS, Long-COVID, and other diseases. Here, treatment to normalize metabolism with Anhydrous Enol-Oxaloacetate has for the first time shown improvements in Pathological Fatigue.

The full study data is made available by the Journal of Translational Medicine.

What is A Medical Food?

While benaGene is a dietary supplement, Oxaloacetate CFS is not. Oxaloacetate CFS is a medical food, a classification distinct from dietary supplements.

Although both benaGene and Oxaloacetate CFS contain thermally stabilized oxaloacetate, they fall under different regulatory classifications with important differences.

Dietary supplements provide supplementary nutritional support for healthy people and are intended to affect the normal structure or function of the human body.

Medical foods, like Oxaloacetate CFS, provide support for the nutritional management of a specific disease or condition that has distinct and established nutritional requirements. Importantly, they are always to be used only under the supervision of a licensed healthcare provider.

Medical foods support those who have trouble digesting and absorbing food and certain nutrients and cannot nutritionally manage their condition through diet modification alone.