Effects of consumption of the beverage containing fulvic acid and silicon on fatigue and sleep quality in healthy Japanese subjects who have received mRNA vaccination for COVID-19 at least three times

Effects of consumption of the beverage containing fulvic acid and silicon on fatigue and sleep quality in healthy Japanese subjects who have received mRNA vaccination for COVID-19 at least three times: a randomized, placebo-controlled, parallel-group comparison study - Effects of consumption of the beverage containing fulvic acid and silicon on fatigue and sleep quality in healthy Japanese subjects who have received mRNA vaccination for COVID-19 at least three times

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052180

Enrollment

Registered

2023-09-12

Start date

2023-09-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese subjects

Interventions

Duration: Four weeks Test food: Beverage containing fulvic acid and silicon Administration: Drink test food each time after waking up and before sleep. *If you forget to take the test food, take

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who have received mRNA vaccination for COVID-19 at least three times 6. Subjects whose fatigue measured by VAS is relatively high among those who agreed to participate in the study 7. Subjects who are judged as eligible to participate in the study by the physician according to the results of the Beck depression inventory (BDITM-II) at screening before consumption

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
1. The fatigue measured by visual analogue scale (VAS), and "sleepiness on rising", "initiation and maintenance of sleep", "frequent dreaming", "refreshing" and "sleep length", and each item in the OSA sleep inventory MA version (OSA-MA) at four weeks after consumption (4w)	—

Secondary

Measure	Time frame
1. The score of Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), and Friendliness (F) in the Profile of Mood States 2nd Edition (POMS2), interferon-alfa, NK cell activity, T-regulatory cell (T-reg), immunoglobulin G4 (IgG4), and glutathione at 4w 2. Each item in the POMS2	—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026