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Effect of Daily Ingestion of Apple on Improving Minor Ailments: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Effect of Daily Ingestion of Apple on Improving Minor Ailments: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study - Beneficial Effect of Daily Ingestion of Apple on Improving Minor Ailments

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043101
Enrollment
20
Registered
2021-01-22
Start date
2021-02-12
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 adults

Interventions

Daily ingestion 100 g of dried apple A for 2 weeks. Daily ingestion 100 g of dried apple B for 2 weeks.

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent. 2. Subjects with relatively low score for VAS questionnaire on fatigue.

Exclusion criteria

Exclusion criteria: 1. Subjects who are under treatment or medication for schizophrenia, depression, mania, nervous disorder or chronic fatigue syndrome. 2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal or affected with infectious diseases which is required to report to the authorities. 3. Subjects who have a major surgical history such as gastrectomy, gastrorrhaphy, enterectomy or other serious gastrointestinal surgeries. 4. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data. 5. Subjects with severe anemia. 6. Pre- or post-menopausal women complaining of obvious physical changes. 7. Subjects who are at risk of having allergic reactions to drugs, foods (especially birch pollen, apples, peaches, pears, cherries, strawberries, plums and apricots). 8. Subjects who eat apples frequently. 9. Subjects who regularly take health foods and/or supplements containing polyphenols. 10. Subjects who regularly take foods fortified with oligosaccharides and/or dietary fiber, yogurt, cultured milk drink, and natto. 11. Subjects who took antibacterial drugs within 12 weeks before the start of ingestion. 12. Heavy smokers, alcohol addicts or subjects with irregular lifestyle. 13. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the current study. 14. Pregnant or lactating women or women who expect to be pregnant during this study. 15. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 16. Subjects determined to be ineligible by the principal investigator.

Design outcomes

Primary

MeasureTime frame
VAS questionnaire on fatigue at 2 weeks after beginning the intake of test food.

Secondary

MeasureTime frame
Intestinal flora, heart rate variability, electroencephalogram during sleeping, sleeping record, survey on subjects' sleeping and mental and physical conditions, urinary metabolites, urinary 8OHdG.

Countries

Japan

Contacts

Public ContactNaoyuki HONMA

Hokkaido Information University Health Information Science Center

hisc-acad.res@s.do-johodai.ac.jp011-385-4430

Outcome results

None listed

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