Glucoside- and Rutinoside-rich Crude Material for Relieving Side Effects of COVID-19 Vaccines
- Conditions
- Side-EffectVaccine Adverse Reaction
- Interventions
- Dietary Supplement: Mulberry juice
- Registration Number
- NCT05387252
- Lead Sponsor
- Taipei Medical University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 93
- Concious
- Mentally capable
- Can comunicate using Mendalin or Taiwanese dialet
- Agree to join the current trial
- Unable to read the google sheets
- dysphagia
- > 65 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Middle volume mulberry juice Mulberry juice 50 ml mulberry juice containing about 240 mg polyphenols Low volume mulberry juice Mulberry juice 10 ml mulberry juice containing about 48 mg polyphenols High volume mulberry juice Mulberry juice 100 ml mulberry juice containing about 480 mg polyphenols
- Primary Outcome Measures
Name Time Method Number of participants with fever Up to four days Event of 38 degrees celsius or above
Change of body temperature Up to four days Daily body temperature of each participant is recorded to obtain serial temperatures including body temperature before vaccination (first day) and body temperatures after vaccination (second, third, and fourth day).
- Secondary Outcome Measures
Name Time Method Number of participants with sign cluster 1 (multiple choices) Up to three days Redness, swelling, pain, lump or mass, or rash and itching at the injection site; axillary swelling and tenderness at the injection arm; axillary swelling and tenderness at the non-injection arm; none
Number of participants with sign cluster 2 (multiple choices) Up to three days Chills, headache, muscle pain, joint pain, fatigue, rash on the body, asthma or breathing difficulty, loss of appetite, nausea or vomiting, diarrhea, stomach ache, insomnia, or drownsiness; none