UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the effects of taking the test food once on replenishing fluids and electrolytes in the body in healthy men aged 20 years or older

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

Weight change

Key secondary outcomes

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)

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

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

Interventions/Control_2

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

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

(1) Male healthy subjects aged 20 years or older at the time of consent
(2) Subjects who can visit the designated medical institution on the scheduled visit date
(3) Subjects who can enter an electronic diary using a PC, smartphone, etc.
(4) Subjects who have been fully explained the purpose and content of the study, fully understood it, voluntarily volunteered to participate, and provided written consent to participate in the study.

Key exclusion 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

Target sample size

32

Name of lead principal investigator

1st name	Toshihiro
Middle name
Last name	Maekawa

Organization

Suntory beverage & Food limited.

Division name

Development & Designed Department

Zip code

211-0067

Address

13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN

TEL

050-1804-0276

Email

Toshihiro_Maekawa@suntory.co.jp

Name of contact person

1st name	Fumiko
Middle name
Last name	Oikawa

Organization

Suntory beverage & Food limited.

Division name

Development & Designed Department

Zip code

211-0067

Address

13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN

TEL

050-1804-2165

Homepage URL

Email

Fumiko_Oikawa@suntory.co.jp

Institute

Suntory beverage & Food limited.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Seishukai Clinic Institutional Review Board

Address

3-18-5 Matsugaya, Taito-ku, Tokyo

Tel

03-5827-0930

Email

k-sudo@seishukai.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

09

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2024

Year

09

Month

26

Day

Date of IRB

2024

Year

09

Month

20

Day

Anticipated trial start date

2024

Year

10

Month

01

Day

Last follow-up date

2024

Year

11

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Exclusion criteria continued)
*1: The study period for human studies is from the time of consent to the completion of all tests.
*2: Based on the diagnostic criteria established by the Japan Diabetes Society (as of October 2019).
*3: This will be presented before the time of consent to provide information for deciding whether to participate.
*4: This refers to those who take or consume drugs approximately three days a week or more.
*5: Those who have not smoked for one year or more are considered to have no smoking habits (including electronic cigarettes).
*6: In "Health Japan 21 (Third Edition)," the "amount of alcohol that increases the risk of lifestyle-related diseases" is defined as those who consume more than approximately 40 g of pure alcohol per day for men.
*7: Based on the classification established by the Japan Society for the Study of Obesity (as of September 2024).

Registered date

2024

Year

09

Month

27

Day

Last modified on

2025

Year

03

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063576