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Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes. -an open-label, randomized, two-periods crossover comparative trial-

Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes. -an open-label, randomized, two-periods crossover comparative trial- - Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes. -an open-label, randomized, two-periods crossover comparative trial-

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052372
Enrollment
20
Registered
2023-10-10
Start date
2023-10-11
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

Heat stress disorder

Interventions

Take the test diet equal to the same amount of body weight loss after sauna by three times. Take the placebo diet equal to the same amount of body weight loss after sauna by three times.

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Males aged more than twenty on the day of consent acquisition. 2. Body weight is over 50 kg. 3. Body fat is below or equal to 25 percent. 4. Those who can use smartphones or PC to record a digital diary. 5. Received a sufficient explanation for the study objective, and voluntarily joined the study with the agreement to informed consent.

Exclusion criteria

Exclusion criteria: 1. Have been taking foods or supplements with functional health claims, which affect the study outcome, such as capsaicin, spices, or any stimulus functional foods for blood flow or body temperature improvement, more than three times a week, and who can't also discontinue intake of these foods. 2. Currently receive medical treatments with drugs. Medications used as needed are acceptable. 3. Alcohol drinking over an average of 40 g/day per week. 4. Have difficulty with blood sampling. 5. Those who have a tattoo. 6. Have difficulty with sweating in a sauna bath. 7. Those whose weight does not fluctuate due to sweating 8. Those who can't enter a sauna bath for ten minutes three times. 9. Those who can't enter a sauna bath for one person due to claustrophobia. 10. Have a scar for a burn injury in a wide area on the body. 11. Have severe diseases or a history of severe diseases in the heart, liver, kidney, or digestive organs. 12. Have allergies to drugs or foods. 13. Those who joined other clinical trials four weeks before, those who have currently joined other clinical trials, and who are planning to join other clinical trials after the consent acquisition in the study. 14. Have above 200 mL blood donation within one month before the start period of the study. 15. Have above 400 mL blood donation within three months before the start period of the study. 16. Have above 1200 mL blood donation volume, which is the sum of the planned blood donation volume in the study and the previous donated blood volume within twelve months before the start period of the study. 17. Those who are unsuitable for the study, judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Intervention difference of changes in body weight after sauna bath

Secondary

MeasureTime frame
Hematologic test Blood biochemistry Urinalysis Physiological test Fractional Excretion of Sodium Electrolyte balance Water balance Physical symptoms

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

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