Protocol for a randomised, double-blind, placebo-controlled clinical trial on the effects of high-dose vitamin B multivitamin supplementation with and without Passiflora incarnata on neural connectivity and oxidative metabolism in healthy adults
Abstract
Introduction: B-vitamins and herbal supplements such as Passiflora incarnata have demonstrated potential benefits for cognitive and neurological functions. This study aims to evaluate the neural and biochemical effects of high-dose vitamin B multivitamin supplementation, with and without P. incarnata, in healthy adults using multimodal neuroimaging and biomarker assessments.
Methods and analysis: This is a phase I/II, randomised, double-blind, placebo-controlled clinical trial involving 108 healthy adults aged 30-55 years, allocated to three groups: (A) high-dose vitamin B multivitamin supplementation with P. incarnata; (B) high-dose vitamin B multivitamin supplementation alone; and (C) placebo. Participants will take two tablets daily for 24 weeks. The primary outcomes are changes in default mode network connectivity assessed using resting-state functional magnetic resonance imaging and diffusion magnetic resonance imaging, together with safety outcomes including vital signs, clinical laboratory parameters and adverse event monitoring. Secondary outcomes include regional brain metabolite concentrations measured by proton magnetic resonance spectroscopy and plasma biomarkers of one-carbon metabolism, including vitamin B6, vitamin B12, folate and homocysteine.
Ethics and dissemination: Ethics approval was granted by the Medical Research Ethics Committee, Ministry of Health Malaysia (NMRR-19-379-46101 (ISR); Protocol Number: Exec B). Results will be disseminated through…
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: 108 participants or records.
Read the paper
Related studies
- Calcium Ions in the Physiology and Pathology of the Central Nervous System
- AI-powered in silico twins: redefining precision medicine through simulation, personalization, and predictive healthcare
- In silico functional, structural and pathogenicity analysis of missense single nucleotide polymorphisms in human MCM6 gene
- In Silico drug repurposing pipeline using deep learning and structure based approaches in epilepsy
- Targeting serotonin receptors with phytochemicals – an in-silico study
- In silico exploration of anti-prostate cancer compounds from differential expressed genes
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.