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A study for evaluating the effects of oral intake of food originated from a microorganism on fatigue and immune functions. A randomized, double-blind, placebo- controlled trial.

A study for evaluating the effects of oral intake of food originated from a microorganism on fatigue and immune functions. A randomized, double-blind, placebo- controlled trial. - A study for evaluating the effects of oral intake of food originated from a microorganism on fatigue and immune functions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028717
Enrollment
40
Registered
2018-06-01
Start date
2017-08-21
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 subjects

Interventions

Food originated from a microorganism, 1 portion of food per day for 14 days. Placebo food, 1 portion of food per day for 14 days.

Sponsors

Department of Sports Medicine (internal medicine), Juntendo University School of Health and Sports Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Healthy individuals aged more than 18 years old, when giving the informed consent. 2)Individuals who are received enough explanation of the purpose and the details of this study, who decided to attend this study with their own will, who have ability of agreement, and who submitted the informed consents in writing.

Exclusion criteria

Exclusion criteria: 1)Individuals who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. 2)Individuals who have chronic diseases and use medicines continuously. 3)Individuals who need the application of medicine containing steroids. 4)Individuals who are seropositive against HBV antigen, HCV antibody, HIV antibody, or HTLV-1 antibody. 5)Individuals who cannot stop eating foods containing ingredients similar to test foods. 6)Individuals who cannot stop eating functional foods which may affect immune functions. 7)Individuals with excessive alcohol-drinking behaviors. 8)Individuals who cannot stop drinking for 2 days before the days of checkup. 9)Individuals who have a medical history of diseases affecting digestion and absorption. 10)Individuals who have a history of inflammatory bowel disease and irritable bowel syndrome. 11)Individuals who are judged as unsuitable for this study based on the results of blood test. 12)Individuals who have under treatment or a history of drug addiction and/or alcoholism. 13)Individuals who are participating or willing to participate in other clinical trials. 14)Individuals whose family works for a company manufacturing or selling healthy foods or functional foods. 15)Individuals who cannot sleep at night due to the irregular work-shift or other reasons. 16)Individuals who are judged unsuitable for this study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Fatigue and stress indices (subjective indices)

Secondary

MeasureTime frame
Fatigue and stress indices (objective indices), immune indices (subjective indices)

Countries

Japan

Contacts

Public ContactKosuke Fukao

Juntendo University School of Health and Sports Science Department of Sports Medicine (internal medicine)

fukao777@juntendo.ac.jp0476-98-1001

Outcome results

None listed

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