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

NCT05387252 | Unknown

• 1 other identifier: N202202030
• Study Type: interventional
• Target: 93
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vaccine Adverse Reaction; Side-Effect

Keywords

COVID-19; Vaccine Adverse Reaction; Side Effect; Inflammation; Pain; Mulberry; IL-17

Outcome Measures

Primary Outcomes (2)

• Change of body temperature

  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).

  Up to four days

• Number of participants with fever

  Event of 38 degrees celsius or above

  Up to four days

Secondary Outcomes (2)

• Number of participants with sign cluster 1 (multiple choices)

  Up to three days

• Number of participants with sign cluster 2 (multiple choices)

  Up to three days

Study Arms (3)

Low volume mulberry juice

EXPERIMENTAL

10 ml mulberry juice containing about 48 mg polyphenols

Dietary Supplement: Mulberry juice

Middle volume mulberry juice

EXPERIMENTAL

50 ml mulberry juice containing about 240 mg polyphenols

Dietary Supplement: Mulberry juice

High volume mulberry juice

EXPERIMENTAL

100 ml mulberry juice containing about 480 mg polyphenols

Dietary Supplement: Mulberry juice

Interventions

Mulberry juice DIETARY_SUPPLEMENT

Mulberry is a common macrophanerophyte that can be found in fields or farms. Mulberry fruits contain a large amount of anthocyanins and a relatively small amount of pro-anthocyanins. The plant is easy to grow and the fruit price is low compared with other types of plants producing anthocyanins, and thus a reliable source for anthocyanin supplements. Current laboratory evidence has shown that specific anthocyanins can reduce inflammation status, and potentially thrombosis. One of the enzymes inhibited by specific anthocyanins is cyclooxygenase which catalyzes the synthesis of prostanoids, including thromboxane and prostaglandins. Moreover, a critical study has shown that cyanidin 3-O-glucoside, the main anthocyanin in mulberry fruit, is an allosteric regulator of interleukin-17A.

High volume mulberry juice; Low volume mulberry juice; Middle volume mulberry juice

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University: lead

MeSH Terms

Conditions

COVID-19; Inflammation; Pain

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• El-Wui Loh, PhD

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

El-Wui Loh, PhD

CONTACT

0903136037; lohew@hotmail.com

Yun-Yun Chou, Msc

CONTACT

0974515039; daliner@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants are told that they would receive a cup of mulberry juice in which the volume is randomized, without knowing the exact dose range.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are divided into three groups, namely, the low dose group (10 ml), middle dose group (50 ml), and high dose group (100 ml).

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: May 31, 2022
• Primary Completion: December 31, 2022
• Study Completion: May 31, 2023
• Last Updated: May 24, 2022

Record last verified: 2022-05