Acute Effects of Artificial Sweeteners' or Sugar's Ingestion on Hemodynamic and Metabolic Stress Response: An Exploratory, Randomized, Cross-over Trial in Healthy Young Women.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Hemodynamic changes
研究概览
简要总结
This exploratory study aims at investigating the acute effects of artificially sweetened and sugar beverage consumption (as compared to water consumption) on acute hemodynamic and metabolic stress response.
详细描述
This single-center study included five visits. The first two visits (screening and familiarization) allowed checking the eligibility of the volunteers. In case of inclusion, the subjects were assigned to a sequence of three experimental conditions (water, sugar and artificial sweeteners), in a randomized, crossover design.
The experimental test was divided into 5 stages:
- a 90 minutes baseline period (t=0-90 min),
- a 30-min mental stress (MS; t=90-120 min), consisting in 5-min periods of Stroop's color word conflict test alternated with 5-min periods of mental arithmetic test.
- a 30-min MS recovery period (t=120-150),
- a 3-min cold pressure test (CPT) was carried out, aiming at immersing one volunteer's forearm in an ice water container at 3°C,
- a 15-min CPT recovery period (t=120-150). 60 min after the beginning of the metabolic test, volunteers will drink 25 mL every 15 min, after 10-sec mouth rinsing, of either an artificially- or sugar-sweetened beverages or water (control).
Hemodynamic stress responses will be measured by repeated blood pressure, heart rate and cardiac output. Repeated venous blood samples will allow to assess metabolic stress responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Caucasian
- •Normal Body Mass Index (18.5 ≤BMI≤ 25 kg/m2)
- •Monophasic oral contraceptive
排除标准
- •Hypertension (Blood pressure >140/90 mmHg)
- •History or actual psychologic/cardiovascular troubles
- •Anemia anamnesis
- •Being Pregnant
- •Weight < 50 kg
- •Blood donation or participation to another study < 8 weeks
- •Claustrophobia
- •Consumption of sugar/artifically-sweetened beverages drinks > 5 dL/d
- •Visual disturbances (daltonism)
- •Low to moderate physical activity (> 4h/wk)
- •Smoker and narcotic consumption
- •Caffeine (> 400 mg/d) and/or alcohol (> 10g/d) consumption
- •Medical treatment
- •Weight variation > 3kg during the last month
研究组 & 干预措施
Sugar
Effects of ingestion of sugar-sweetened beverages on acute stress response
干预措施: Ingestion of sugar-sweetened beverages (Other)
Artificial sweetener
Effects of ingestion of artificially-sweetened beverages on acute stress response
干预措施: Ingestion of artificially-sweetened beverages (Other)
Water
Effects of ingestion of water on acute stress response
干预措施: Ingestion of water (Other)
结局指标
主要结局
Hemodynamic changes
时间窗: Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)
Hemodynamic changes elicited by stress will be assessed by means of systemic vascular resistance calculated as (blood flow):(mean arterial pressure, and expressed in arbitrary units
次要结局
- Changes in concentration of blood glucose(Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the test)
- Changes in concentration of blood insulin(Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the test)
- Changes in blood non-esterified fatty acid concentration(Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the tes)
- Metabolic changes(Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test))
研究者
Luc Tappy, MD
Full Professor
University of Lausanne