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Confirmation of the effect of hydration in the body through the ingestion of research foods

Confirmation of the effect of hydration in the body through the ingestion of research foods -A randomized, placebo controlled, single blind, three-period crossover comparative trial- - Confirmation of the effect of hydration in the body through the ingestion of research foods -A randomized, placebo controlled, single blind, three-period crossover comparative trial-

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052741
Enrollment
18
Registered
2023-11-12
Start date
2023-11-13
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 male adults

Interventions

Test food 1, equal to the same amount of body weight loss after sauna, is ingested once. Test food 2, equal to the same amount of body weight loss after sauna, is ingested once. Placebo food, equal to

Sponsors

IMEQRD Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1)Male subjects ranging in age from 20 to 65 at informed consent. (2)Subjects ranging in BMI from 18.5 to less than 25.0 kg/m2. (3)Subjects who can visit the designated facility on measurement days. (4)Subjects who can use smartphones or PC to record a digital diary. (5)Subjects who can make self-judgment and voluntarily gave written informed consent.

Exclusion criteria

Exclusion criteria: (1) with irregular life rhythm (e.g., irregular shift work). (2) Heavily drinkers (40 g or more as pure alcohol). (3) Subjects having a habit of smoking. (4) Persons who regularly consume health foods or supplements such as foods for specified health uses or foods with functional claims that may affect the study, and cannot stop taking them after consent is obtained (5) Subjects with a systolic blood pressure of less than 90 mmHg. (6) Subjects who donated their blood components and/or whole blood (over 0.2 L) within the past 4 weeks. (7) Subjects who donated their whole blood (over 0.4 L) within the past 12 weeks. (8) Subjects being collected in total of their blood (over 1.2 L) within the past 12 months and in this research. (9) Subjects being under other clinical tests, or participated in those within the past four weeks, or will join those after the consent. (10) Subjects who meet any of the following: (a) suffering from heart, liver, or kidney disease (including complications of other diseases) (b) having a history of cardiovascular disease (c) diabetes (d) allergic to the test foods and/or required one. (11) Persons who have difficulty collecting blood (12) Those who have difficulty sweating in the sauna (13) Persons who are unable to take a sauna bath for 10 minutes x 3 times (14) People who do not like closed spaces and cannot enter a solo sauna (15) Persons with extensive burn scars (16) Persons with tattoos (17) Those who are judged by the study director or study sub-physician to be unsuitable as study subjects.

Design outcomes

Primary

MeasureTime frame
Osmolality (serum, urine)

Secondary

MeasureTime frame
Blood tests, Urine tests, Urine volume, Body weight, body water balance, body temperature, blood pressure, pulse

Countries

Japan

Contacts

Public ContactKaori Matsuoka

Suntory beverage & Food limited. Development & Designed Department

Kaori_Matsuoka@suntory.co.jp05031820550

Outcome results

None listed

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