건강에 좋은 euhydrated 남성과 여성의 체액 균형에 대한 음료량, 글리세롤 농도 및 나트륨 농도의 영향
The presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination.
The purpose of this study is to determine the effect of sodium and glycerol concentrations at various fluid intake volumes on fluid balance in healthy, euhydrated men and women.
연구 개요
상태
정황
개입 / 치료
- 다른: Placebo beverage, kiwi-strawberry flavor
- 다른: Electrolyte solution without glycerol beverage 1
- 다른: Electrolyte solution without glycerol beverage 2
- 다른: Electrolyte solution without glycerol beverage 3
- 다른: Electrolyte solution with glycerol beverage 1
- 다른: Electrolyte solution with glycerol beverage 2
- 다른: Electrolyte solution with glycerol beverage 3
- 다른: Base with glycerol, no electrolytes beverage 1
- 다른: Base with glycerol, no electrolytes beverage 2
- 다른: Base with glycerol, no electrolytes beverage 3
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Florida
-
Bradenton, Florida, 미국, 34210
- IMG Academy/GSSI Bradenton Gatorade Sports Science Institute
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St. Petersburg, Florida, 미국, 33705
- GCP Research
-
-
New York
-
Valhalla, New York, 미국, 10595
- Gatorade Sports Science Institute
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subject is male or female
- If female, subject is not pregnant
- Subject is 18-50 years of age, inclusive
- Subject is at least recreationally active (engaged in light to moderate-intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)
- Subject does not smoke (or has quit for at least 6 months)
- Subject is not taking medication that may interfere with the study (e.g., diuretics)
- Subject has no health conditions that would interfere with the study (e.g. cardiovascular, renal, or metabolic diseases)
- Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
- Subject is willing to fast overnight (~8-12 hours)
- Subject is willing to refrain from vigorous exercise for 24 hours
- Subject is willing to eat the exact same food the day prior to each visit to the laboratory
- Provision of written consent to participate
Exclusion Criteria:
- Subject has participated in a clinical trial within the past 30 days
- Subject has participated in any PepsiCo trial within past 6 months
- Subject has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
- Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Placebo beverage
Base beverage, no electrolytes, no glycerol |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose |
|
실험적: Electrolyte solution without glycerol beverage 1
Higher electrolytes lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
실험적: Electrolyte solution without glycerol beverage 2
Lower electrolytes mid-volume |
6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
실험적: Electrolyte solution without glycerol beverage 3
Higher electrolytes higher volume |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
실험적: Electrolyte solution with glycerol beverage 1
Lower electrolytes, lower glycerol, lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
실험적: Electrolyte solution with glycerol beverage 2
Higher electrolytes, higher glycerol, lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
실험적: Electrolyte solution with glycerol beverage 3
Higher electrolytes, higher glycerol, higher volume |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
실험적: Base with glycerol beverage 1
No electrolytes, higher glycerol, lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
실험적: Base with glycerol beverage 2
No electrolytes, lower glycerol, mid-volume |
6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
실험적: Base with glycerol beverage 3
No electrolytes, higher glycerol, higher volume |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fluid balance
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
Calculated as change in body mass kg and % |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Urine mass
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(g) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Urine specific gravity
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(au) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Urine osmolality
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(mosmol/kg) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Whole blood hematocrit
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(%) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Whole blood hemoglobin concentration
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(g/dl) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum sodium concentration
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum potassium concentration
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum chloride concentration (mmol/L)
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum glucose concentration
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mg/dl) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum glycerol concentration
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum copeptin concentration
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(pmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum osmolality
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mosmol/kg) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Blood pressure
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(systolic/diastolic) (mmHg) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Heart rate
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(bpm) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Subjective measures of gastrointestinal discomfort and headache (VAS)
기간: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
Rated on a 100 point scale from none to severe for headache, lightheaded, stomach upset, nausea, burping, stomach bloating, abdominal discomfort, stomach fullness, vomiting, diarrhea). |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Menstrual categorization
기간: Screening visit
|
Current status (e.g., contraception, regular periods or not, etc.) |
Screening visit
|
|
Adverse Events
기간: From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6)
|
Documented changes in health and symptoms |
From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Lindsay Baker, PhD, PepsiCo R&D/Gatorade and Sports Science Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .