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Study on the effects of test food intake on absorption and excretion of water and electrolytes in the body under the dehydration model with sauna load.

Study on the effects of test food intake on absorption and excretion of water and electrolytes in the body under the dehydration model with sauna load: an open-label, randomized, two-periods cross-over comparative controlled trial - Study on the effects of test food intake on absorption and excretion of water and electrolytes in the body under the dehydration model with sauna load: an open-label, randomized, two-periods cross-over comparative controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054399
Enrollment
22
Registered
2024-05-26
Start date
2024-05-27
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

Dehydration, heatstroke

Interventions

The test food is consumed in three divided doses equal to the amount of weight loss after the sauna bathing. The control food is consumed in three divided doses equal to the amount of weight loss afte

Sponsors

IMEQRD Co. Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Males aged 20 or older at the time of consent. 2. Whose Body weight is 50 kg or more. 3. Whose body fat percentage is 25% or less. 4. Those who are able to input data into an electronic diary by PC, smart phone, etc. 5. Those who have received a full explanation of the objective and content of the study, understand it well, and voluntarily volunteer to participate, and agree to participate in the study in writing.

Exclusion criteria

Exclusion criteria: 1. Those who regularly use foods or supplements with functional health claims that may affect the study outcome three times or more a week and cannot stop using them from the time of consent (e.g., Health foods containing capsaicin, spices, or other strong stimulants, or Health foods that have effects such as improving blood flow, increasing body temperature, or inducing sweating). 2. Those who are currently receiving drug treatment (however, ad-hoc treatment is allowed). 3. Heavy drinkers (those with excessive drinking habits exceeding approximately 40 grams of pure alcohol equivalent per day). 4. Those who have difficulty in blood collection or have had a history of feeling sick immediately after blood collection, such as vagal reflex in the past. 5. Those with tattoos. 6. Those who have no experience in sauna. 7. Those who are aware that they have difficulty sweating in sauna. 8. Those who cannot enter an one-person sauna because of claustrophobia. 9. Those who have extensive burn scars. 10. Those with a history or current history of serious heart, liver, kidney, or digestive organ disease. 11. Those who are allergic to medicines or foods. 12. Those who are currently participating in a clinical study on other drugs or health foods, who had participated in a clinical study on other drugs or health foods within 4 weeks, or who are scheduled to participate in the other clinical study after the consent to participate in this study. 13. Those who have donated blood components or 200 mL of whole blood in the month prior to the start of the study. 14. Those who have donated 400 mL of whole blood 3 months prior to the start of the study. 15. whose total blood collection volume, including the planned volume for the study and the volume collected in the previous 12 months, exceeds 1200 mL prior to the start of the study. 16. Whose participation in the study is deemed inappropriate by the principal investigator or subinvestigator.

Design outcomes

Primary

MeasureTime frame
-Changes in body weight after sauna bathing

Secondary

MeasureTime frame
-Hematologic test -Blood biochemistry test -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