Effects of Coca-Cola Zero Sugar Consumption on Urinary Metabolites in Healthy Adults
Metabolic Profiling of Acesulfame Potassium After Coca-Cola Zero Sugar Consumption in Healthy Adults
연구 개요
상세 설명
Non-nutritive sweeteners (NNS) are widely used as sugar substitutes in reduced-calorie foods and beverages. Among these, acesulfame potassium (Ace-K) is extensively incorporated into commercially available soft drinks because of its high sweetening potency, thermal stability, and minimal caloric contribution. Following oral ingestion, Ace-K is rapidly absorbed and excreted predominantly unchanged in urine, making it a promising biomarker of NNS consumption and dietary exposure. However, limited information is available regarding the urinary pharmacokinetics of Ace-K following consumption of commercially formulated beverages under free-living conditions.
Proton nuclear magnetic resonance (¹H NMR) spectroscopy enables simultaneous quantitative analysis of exogenous compounds and endogenous metabolites in complex biological samples. By applying the same analytical platform to both the intervention beverage and sequential urine samples, this study investigates the relationship between the ingested dose of Ace-K and its urinary excretion profile while simultaneously evaluating short-term metabolic responses following Coca-Cola Zero Sugar consumption.
This non-randomized, within-subject controlled study compares the urinary metabolomic response after consumption of Coca-Cola Zero Sugar with that observed following consumption of still water. The study aims to characterize the urinary appearance and elimination kinetics of Ace-K, quantify pharmacokinetic parameters including time to peak concentration and urinary elimination half-life, and explore acute changes in urinary metabolite profiles associated with Coca-Cola Zero Sugar consumption using quantitative ¹H NMR metabolomics.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Prague
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Suchdol, Prague, 체코, 16500
- Czech University of Life Sciences Prague
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Healthy adults aged 18 to 60 years
- Able and willing to provide written informed consent
- Willing to consume 500 mL of Coca-Cola Zero Sugar and 500 mL of still water during separate study periods
- Willing to collect urine samples before and during the 24 hours after each intervention according to the study instructions
- Willing to avoid foods and beverages containing non-nutritive sweeteners for 48 hours before each study period
Exclusion Criteria:
- Younger than 18 years or older than 60 years
- Current smoker
- Known kidney disease or metabolic disease
- Regular use of prescription medications
- Use of antibiotics in last 3 months
- Consumption of foods or beverages containing non-nutritive sweeteners within 48 hours before either study period
- Unable or unwilling to comply with the study procedures or urine collection schedule
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Coca-Cola Zero Sugar
Participants consumed 500 mL of Coca-Cola Zero Sugar with breakfast.
Spot urine samples were collected before beverage consumption and repeatedly over the subsequent 24-hour period for metabolomic and pharmacokinetic analyses using proton nuclear magnetic resonance (¹H NMR) spectroscopy.
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Participants consumed a single oral dose of 500 mL Coca-Cola Zero Sugar with breakfast.
The intervention beverage was consumed within approximately 10-20 minutes.
Spot urine samples were collected before consumption and repeatedly over the subsequent 24-hour period for metabolomic and pharmacokinetic analyses using proton nuclear magnetic resonance (¹H NMR) spectroscopy.
다른 이름들:
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활성 비교기: Still Water
Participants consumed 500 mL of still water with breakfast following a one-month washout period.
Spot urine samples were collected before beverage consumption and repeatedly over the subsequent 24-hour period using the same sampling schedule as the Coca-Cola Zero Sugar arm.
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Participants consumed a single oral dose of 500 mL still water with breakfast under otherwise comparable conditions following a one-month washout period.
Spot urine samples were collected before consumption and repeatedly over the subsequent 24-hour period using the same sampling schedule as the intervention arm.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Urinary concentration of acesulfame potassium (Ace-K)
기간: Baseline and up to 24 hours after beverage consumption
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Quantitative measurement of urinary acesulfame potassium (Ace-K) concentration following consumption of 500 mL Coca-Cola Zero Sugar compared with still water, determined by quantitative proton nuclear magnetic resonance (¹H NMR) spectroscopy and used to characterize urinary excretion kinetics.
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Baseline and up to 24 hours after beverage consumption
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Urinary metabolomic profile
기간: Baseline and up to 24 hours after beverage consumption
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Quantitative analysis of endogenous and exogenous urinary metabolites using proton nuclear magnetic resonance (¹H NMR) spectroscopy to compare metabolomic responses following Coca-Cola Zero Sugar and still water consumption.
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Baseline and up to 24 hours after beverage consumption
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to peak urinary acesulfame potassium concentration (Tmax)
기간: Up to 24 hours after beverage consumption
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Determination of the time required to reach maximum urinary acesulfame potassium concentration following beverage consumption.
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Up to 24 hours after beverage consumption
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공동 작업자 및 조사자
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 연구와 관련된 용어
기타 연구 ID 번호
- 155/23 S-IV
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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