Investigation of the Water and Electrolyte Replenishment Effects of an Electrolyte Replenishing Jelly on a Sauna-Induced Dehydration Model in Healthy Adults.

UMIN ID: UMIN000054163

Registered date:22/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2024/06/03
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Sequence group 1: Period I, intake of electrolyte replenishment drink; Washed out period, four days or more; Period II, Intake of electrolyte replenishment jelly.
Sequence group 2: Period I, intake of electrolyte replenishment jelly; Washed out period, four days or more; Period II, Intake of electrolyte replenishment drink.

Outcome(s)

• Primary Outcome: Fractional excretion of sodium
• Secondary Outcome: Blood tests: White blood cells, red blood cells, hemoglobin, hematocrit, platelet, Na, K, Cl, Ca, total protein, albumin, blood urea nitrogen, creatinine, glucose, serum osmolality Urine tests: Urine volume, urine specific gravity, urine osmolality, Na, K, Cl, Mg, Ca, creatinine, urine urea nitrogen, inorganic phosphorus ion, urine protein, urine sugar, urobilinogen, bilirubin, occult blood Others: Body weight, Plasma volume, body water balance, body electrolyte balance , body temperature, blood pressure, pulse

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: 1) Have donated 400 mL of whole blood 3 months before the screening. 2) Have donated 200 mL of whole blood or blood components 1 month before the screening. 3) The sum of donated blood volume in the study and donation within 12 months before the screening test is over 1200 mL. 4) Have been comprehensively judged by the principal investigator to require treatment for dehydration based on clinical indicators at the screening test. 5) Who participated in a study involving the use of other foods or drugs, or the application of cosmetics or drugs within 4 months before obtaining consent, or who will participate in other studies while participating in this study. 6) Currently undergoing treatment with some kind of drug or herbal medicine. 7) Currently taking over-the-counter drugs, quasi-drugs and foods or supplements with specified health claims or who cannot withdraw these during the study period. 8) Heavily drinkers (40g or more as pure alcohol). 9) Have unstable lifestyles such as shift workers, and night shifts. 10) Have a smoking habit (less than 1 year after quitting smoking). 11) May change lifestyles such as long-term travel during the study. 12) Have a habit go to a sauna (at least over once a month), or have never experienced a sauna. 13) Have extensive burn scars. 14) Have tattoos. 15) Have Claustrophobia and unable to be in sauna. 16) Have drug addiction, or have been drug addicted. 17) Have difficulty with blood donation, or have experienced bad mood, deterioration of physical condition, or vasovagal reflex due to blood collection in the past. 18) Have a history or current medical history of heatstroke. 19) Have a history or current medical history of severe liver, kidney, heart, respiratory, endocrine, metabolic diseases, etc. 20) Those who are judged by the principal investigator to be inappropriate as research subjects.

Related Information

• Primary Sponsor: IMEQRD Co., Ltd.
• Source(s) of Monetary Support: Ajinomoto Co., Inc.