Examination of the effect of a test food on weather-related pain and autonomic imbalance

JRCT ID: jRCTs041220004

Registered date:14/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic pain, autonomic imbalance, headache
• Date of first enrollment: 14/04/2022
• Target sample size: 30
• Study type: Interventional

Intervention(s)

After taking the test food, expose the subjects to a low pressure environment.
Subjects are assigned to two groups, and each group is subjected to two exposure experiments with a washout period of at least 2 weeks. In the exposure experiment 1, group 1 is asked to ingest the test food and is exposed to low pressure 3 hours later. In addition, in the exposure experiment 2, group 1 is asked to ingest the placebo food and is exposed to low pressure 3 hours later. Group 2 is asked to consume the foods twice in reverse order, and subject is exposed to loe pressure using the same protocol.

Outcome(s)

Primary Outcome

Rate of improvement by test food intake fore changes in NRS score caused by low pressure
exposure

Secondary Outcome

1) Mood score (POMS), anxiety / depression score (HADS)
2) Blood pressure, heart rate, percutaneous arterial oxygen saturation (SpO2), salivary amylase activity
3) Dizziness induction threshold by electrical stimulation of the inner ear
4) Left and right eardrum temperature
5) Artificial weather data

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

Meet all of the following selection criteria
1) Those who have consented to participate in the research (adult men and women 20-64 years old)
2) Weather-related pain holders with moderate headaches
3) Those who can participate in one pre-interview and two exposure experiments on the schedule specified by the researcher
4) Those who can submit the results of the medical examination as needed

Exclude criteria

Those who violate any of the following exclusion criteria
1) Aichi Medical University student
2) Outpatients at Aichi Medical University Hospital Pain Relief Surgery / Pain Center
3) Persons with drug allergies and food allergies
4) Those who plan to take or may take any new treatment during the study period
5) Those who regularly use health foods and supplements such as foods for specified health use and foods with functional claims that are expected to improve pain
6) Pregnant, lactating and wishing to become pregnant during the study period
7) Those who cannot understand the contents of the questionnaire
8) Others (during medication, treatment, etc.) Persons who are judged by the investigator and the person in charge of research to be inappropriate as participants

Related Information

• Primary Sponsor: Ushida Takahiro
• Secondary Sponsor: Pascal Universe Co. Ltd.
• Source(s) of Monetary Support: Otsuka Pharmaceutical Co., Ltd.