Glucoside- and Rutinoside-rich Crude Material for Relieving Side Effects of COVID-19 Vaccines

Taipei Medical University

Status: Unknown

Conditions: Vaccine Adverse Reaction; Side-Effect

Treatments: Dietary Supplement: Mulberry juice

Study type: Interventional

Funder types: Other

Identifiers

NCT05387252

N202202030

Details and patient eligibility

About

Urgent vaccine development plus the characteristics of the coronavirus have caused the relatively more safety problems in COVID-19 vaccines than other classic vaccines and unavoidably raises more concerns among those who accept or consider to be vaccinated. Mulberry juice consists of a large amount of anthocyanin. The abnormally high interleukin-17A level is frequently seen in patients with inflammation status or diseases with inflammation features. Some specific anthocyanins can reduce cyclooxygenase and nitrogen oxide, and the pharmacological effect of the major anthocyanin in mulberry juice imitates that of interleukin-17A antagonists. These features make mulberry juice a potential crude material for reducing inflammation and pain induced by COVID-19 vaccinations. The investigators propose a randomized control trial to explore the dose-response effects of three different volumes of mulberry juice on the incidence and severity of COVID-19 induced side effects. The findings should be helpful for nutrition supplementation in COVID-19 vaccinations and may improve public coordination of COVID-19 vaccinations.

Full description

Since the outbreak of Coronavirus Disease-2019 (COVID-19), the size of the infected population continues to expand, and the number of deaths due to the infection continues to climb. Massive vaccination has become the most critical measure to control the pandemic. Vaccination may cause side effects. Urgent vaccine development plus the characteristics of the coronavirus have caused the relatively more safety problems in COVID-19 vaccines than other classic vaccines and unavoidably raises more concerns among those who accept or consider to be vaccinated. Mulberry juice consists of a large amount of anthocyanin. The abnormally high interleukin-17A level is frequently seen in patients with inflammation status or diseases with inflammation features. Previous cell and animal studies have shown that some specific anthocyanins can reduce cyclooxygenase and nitrogen oxide, and the pharmacological effect of the major anthocyanin in mulberry juice imitates that of interleukin-17A antagonists. These features make mulberry juice a potential crude material for reducing inflammation and pain induced by COVID-19 vaccinations. The investigators propose a randomized control trial investigating the dose-response effects of three different volumes of mulberry juice on the incidence and severity of COVID-19 induced side effects and build up initial dose-response models for future reference in nutrition supplementation in COVID-19 vaccinations and improve public coordination of COVID-19 vaccinations.

Enrollment: 93 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Concious
• Mentally capable
• Can comunicate using Mendalin or Taiwanese dialet
• Agree to join the current trial

Exclusion criteria

• Unable to read the google sheets
• dysphagia
• > 65 years

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 3 patient groups

Low volume mulberry juice

Experimental group

Description:

10 ml mulberry juice containing about 48 mg polyphenols

Treatment:

Dietary Supplement: Mulberry juice

Middle volume mulberry juice

Experimental group

Description:

50 ml mulberry juice containing about 240 mg polyphenols

Treatment:

Dietary Supplement: Mulberry juice

High volume mulberry juice

Experimental group

Description:

100 ml mulberry juice containing about 480 mg polyphenols

Treatment:

Dietary Supplement: Mulberry juice