MCT-Induced Ketosis and Fiber in Rheumatoid Arthritis (MIKARA)-Study Protocol and Primary Endpoint Results of the Double-Blind Randomized Controlled Intervention Study Indicating Effects on Disease Activity in RA Patients
Abstract
Fatty acids, such as medium-chain fatty acids (MCFAs) and short-chain fatty acids (SCFAs), both important components of a normal diet, have been reported to play a role in bone-related diseases such as rheumatoid arthritis (RA). However, the role of medium-chain triglycerides (MCTs) has not been investigated in RA to date. The aim of this study was to investigate the effect of supplementation of regular diet with MCT with and without fiber on disease activity as measured with the SDAI (Simplified Disease Activity Index) in RA patients. A total of 61 RA patients on stable drug treatment were randomly assigned to a twice-daily control regimen or to a twice-daily regimen of a formulation containing medium-chain triglycerides (MCTs) 30 g/day for 8 weeks followed by a second twice-daily regimen of combining MCT (30 g/day) plus fiber (30 g/day) for an additional 8 weeks. The control group received a formulation containing long-chain triglycerides (LCTs) instead of MCTs. The preliminary results showed a significant reduction in SDAI from baseline to week 16 in the test group and a significant increase in β-hydroxybutyrate (BHB) levels, while no improvement in SDAI was observed in the control group.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 61 participants or records.
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