RESTORE ME: a RCT of oxaloacetate for improving fatigue in patients with myalgic encephalomyelitis/chronic fatigue syndrome
BackgroundThe energy metabolite oxaloacetate is significantly lower in the blood plasma of ME/CFS subjects. A previous open-label trial with oxaloacetate supplementation demonstrated a significant reduction in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)-related fatigue.MethodsIn this...
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Frontiers Media S.A.
2024-11-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2024.1483876/full |
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| author | Alan Cash Suzanne D. Vernon Candace Rond Lucinda Bateman Saeed Abbaszadeh Jennifer Bell Brayden Yellman David L. Kaufman |
| author_facet | Alan Cash Suzanne D. Vernon Candace Rond Lucinda Bateman Saeed Abbaszadeh Jennifer Bell Brayden Yellman David L. Kaufman |
| author_sort | Alan Cash |
| collection | DOAJ |
| description | BackgroundThe energy metabolite oxaloacetate is significantly lower in the blood plasma of ME/CFS subjects. A previous open-label trial with oxaloacetate supplementation demonstrated a significant reduction in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)-related fatigue.MethodsIn this follow-up trial, 82 ME/CFS subjects were enrolled in a 3-month randomized, double-blinded, controlled study, receiving either 2,000 mg of oxaloacetate or control per day. The primary endpoints were safety and reduction in fatigue from baseline. Secondary and exploratory endpoints included functional capacity and general health status.ResultsAnhydrous enol-oxaloacetate (oxaloacetate) was well tolerated at the tested doses. Oxaloacetate significantly reduced fatigue by more than 25% from baseline, while the control group showed a non-significant reduction of approximately 10%. Intergroup analysis showed a significant decrease in fatigue levels in the oxaloacetate group (p = 0.0039) with no notable change in the control group. A greater proportion of subjects in the oxaloacetate group achieved a reduction in fatigue greater than 25% compared to the control group (p < 0.05). Additionally, 40.5% of the oxaloacetate group were classified as “enhanced responders,” with an average fatigue reduction of 63%. Both physical and mental fatigue improved with oxaloacetate supplementation.ConclusionOxaloacetate is well tolerated and effectively helps reduce fatigue in ME/CFS patients.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT05273372. |
| format | Article |
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| institution | Kabale University |
| issn | 1664-2295 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Neurology |
| spelling | doaj-art-f4c05ba309244ef2a5d4e18bfeacc1d82024-11-27T13:54:17ZengFrontiers Media S.A.Frontiers in Neurology1664-22952024-11-011510.3389/fneur.2024.14838761483876RESTORE ME: a RCT of oxaloacetate for improving fatigue in patients with myalgic encephalomyelitis/chronic fatigue syndromeAlan Cash0Suzanne D. Vernon1Candace Rond2Lucinda Bateman3Saeed Abbaszadeh4Jennifer Bell5Brayden Yellman6David L. Kaufman7Terra Biological LLC, San Diego, CA, United StatesBateman Horne Center, Salt Lake City, UT, United StatesBateman Horne Center, Salt Lake City, UT, United StatesBateman Horne Center, Salt Lake City, UT, United StatesBateman Horne Center, Salt Lake City, UT, United StatesBateman Horne Center, Salt Lake City, UT, United StatesBateman Horne Center, Salt Lake City, UT, United StatesCenter for Complex Diseases, Seattle, WA, United StatesBackgroundThe energy metabolite oxaloacetate is significantly lower in the blood plasma of ME/CFS subjects. A previous open-label trial with oxaloacetate supplementation demonstrated a significant reduction in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)-related fatigue.MethodsIn this follow-up trial, 82 ME/CFS subjects were enrolled in a 3-month randomized, double-blinded, controlled study, receiving either 2,000 mg of oxaloacetate or control per day. The primary endpoints were safety and reduction in fatigue from baseline. Secondary and exploratory endpoints included functional capacity and general health status.ResultsAnhydrous enol-oxaloacetate (oxaloacetate) was well tolerated at the tested doses. Oxaloacetate significantly reduced fatigue by more than 25% from baseline, while the control group showed a non-significant reduction of approximately 10%. Intergroup analysis showed a significant decrease in fatigue levels in the oxaloacetate group (p = 0.0039) with no notable change in the control group. A greater proportion of subjects in the oxaloacetate group achieved a reduction in fatigue greater than 25% compared to the control group (p < 0.05). Additionally, 40.5% of the oxaloacetate group were classified as “enhanced responders,” with an average fatigue reduction of 63%. Both physical and mental fatigue improved with oxaloacetate supplementation.ConclusionOxaloacetate is well tolerated and effectively helps reduce fatigue in ME/CFS patients.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT05273372.https://www.frontiersin.org/articles/10.3389/fneur.2024.1483876/fullchronic fatigue syndromeME/CFSoxaloacetatefatiguefatigue treatmentME/CFS treatment |
| spellingShingle | Alan Cash Suzanne D. Vernon Candace Rond Lucinda Bateman Saeed Abbaszadeh Jennifer Bell Brayden Yellman David L. Kaufman RESTORE ME: a RCT of oxaloacetate for improving fatigue in patients with myalgic encephalomyelitis/chronic fatigue syndrome Frontiers in Neurology chronic fatigue syndrome ME/CFS oxaloacetate fatigue fatigue treatment ME/CFS treatment |
| title | RESTORE ME: a RCT of oxaloacetate for improving fatigue in patients with myalgic encephalomyelitis/chronic fatigue syndrome |
| title_full | RESTORE ME: a RCT of oxaloacetate for improving fatigue in patients with myalgic encephalomyelitis/chronic fatigue syndrome |
| title_fullStr | RESTORE ME: a RCT of oxaloacetate for improving fatigue in patients with myalgic encephalomyelitis/chronic fatigue syndrome |
| title_full_unstemmed | RESTORE ME: a RCT of oxaloacetate for improving fatigue in patients with myalgic encephalomyelitis/chronic fatigue syndrome |
| title_short | RESTORE ME: a RCT of oxaloacetate for improving fatigue in patients with myalgic encephalomyelitis/chronic fatigue syndrome |
| title_sort | restore me a rct of oxaloacetate for improving fatigue in patients with myalgic encephalomyelitis chronic fatigue syndrome |
| topic | chronic fatigue syndrome ME/CFS oxaloacetate fatigue fatigue treatment ME/CFS treatment |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2024.1483876/full |
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