The effect of test foods on water and electrolyte replacement in a dehydration model

UMIN ID: UMIN000055647

Registered date:30/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2024/10/01
• Target sample size: 32
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The test food is taken in an amount equal to the amount of weight lost, divided into three portions.
The test food is taken in an amount equal to the amount of weight lost, divided into three portions.

Outcome(s)

• Primary Outcome: Weight change
• Secondary Outcome: 1. Physiological test: body temperature, blood pressure, pulse rate 2. Blood biochemistry test: total protein (TP), albumin (Alb), Na, K, Cl, creatinine (CRE), glucose (GLU), osmolality 3. Urine test: excretion amount, Na, K, Cl, CRE, osmolality 4. FENa value (urinary sodium) 5. Electrolyte balance and water balance 6. Core body temperature 7. Oral water value at rest 8. Physical symptoms (questionnaire)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: Representative items are listed below. (1) Subjects with a systolic blood pressure of less than 90 mmHg (2) Subjects who have donated blood components or collected 200 mL or more of whole blood from 4 weeks before the start of the study until the start of the study (3) Subjects who have collected 400 mL or more of whole blood from 12 weeks before the start of the study until the start of the study (4) Subjects whose total planned blood collection for the study exceeds 1200 mL when added to the amount of blood collected from the month 12 months before the start of the study (5) Subjects who are participating as test subjects in other studies or who have completed a study within 4 weeks of participating*1 (6) Subjects who meet any of the following criteria a) Subjects with heart, liver, or kidney disease (including complications of other diseases) b) Subjects with a history of cardiovascular disease c) Subjects with diabetes*2 d) Subjects with allergies to the test foods*3 e) Subjects with a history of serious diseases such as cancer or tuberculosis (7) Subjects who are undergoing treatment at the time of screening (8) Subjects who regularly*4 take health foods or supplements such as foods for specified health uses or functional foods that may affect the study and cannot stop taking them from the time of consent (9) Subjects who smoke*5 (10) Subjects who consume more than 40 g of alcohol per day*6 (11) Subjects with extremely irregular eating habits (12) Shift workers or night workers (13) Subjects who have difficulty obtaining blood samples (14) Subjects who weigh less than 50 kg (15) Subjects who are obese (BMI 25 and above)*7 (16) Subjects who are otherwise deemed inappropriate for the study by the principal investigator or sub-investigator

Related Information

• Primary Sponsor: Suntory beverage & Food limited.
• Source(s) of Monetary Support: None