Effect of Flavored, Carbonated Drinks on Salivary Flow, Salivary Composition, and Taste Perceptions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Salivary flow rate
研究概览
简要总结
To determine the effect of flavored, carbonated drinks on salivary flow rate, saliva composition, and taste perceptions compared with control drinks (water, carbonated water, non-carbonated)
详细描述
Previous studies have shown that drinking a beverage can stimulate the production of saliva and alter its composition. These effects could impact oral processing and taste perceptions. Various ingredients in beverages such as carbonation may affect saliva and oral processing. The objective of this study is to determine the effect of flavored carbonated beverages on salivary flow rate, saliva composition (pH, mucins, carbonic anhydrase, and total protein), and taste perceptions compared with unflavored and non-carbonated control drinks.
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
- Single (Outcomes Assessor)
盲法说明
Partially blinded. Uncarbonated flavored drinks and water are distinguishable from carbonated flavored drinks and water.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is male or female
- •If female, subject is not pregnant or nursing (based on self-report)
- •Subject is 18-45 years of age, inclusive
- •Subject is a regular consumer of carbonated drinks (questionnaire)
- •Subject is willing to avoid alcohol consumption 24 hours prior to visits
- •Subject is willing to fast (no food or gum) for 2 hours prior to study sessions
- •Able to speak, write, and read English
- •Provision of written consent to participate
排除标准
- •Subject smokes, vapes, or uses any nicotine/tobacco products (or has quit for less than 6 months)
- •Subject currently has or recently had an illness (cold, flu, COVID) within the past month
- •Subject has a condition affecting the oral cavity such as Xerostomia (dry mouth), Sores/lesions, Untreated dental caries, Major dental implants/appliances (including dentures)
- •Subject has a reduced sense of taste (dysgeusia) or smell (parosmia)
- •Subject has a health condition that would interfere with the study as indicated on the general health questionnaire (GHQ) (including cardiovascular, renal, or metabolic diseases)
- •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 PepsiCo product. If subject is unsure if a company would be considered a competitor to PepsiCo, 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.
研究组 & 干预措施
Flavored carbonated drink 1
Flavored carbonated beverage with nutritive sweeteners
干预措施: Beverage (Other)
Flavored carbonated drink 2
Flavored carbonated beverage with non-nutritive sweeteners
干预措施: Beverage (Other)
Flavored drink
Flavored non-carbonated beverage with nutritive sweeteners
干预措施: Beverage (Other)
Flavored non-carbonated drink
Flavored non-carbonated beverage with non-nutritive sweeteners
干预措施: Beverage (Other)
Carbonated Water
Unflavored carbonated water
干预措施: Beverage (Other)
Water
Plain, unflavored, non-carbonated water
干预措施: Beverage (Other)
结局指标
主要结局
Salivary flow rate
时间窗: At each of six 2 hour test sessions 2-8 days apart at same time of day
5 minute passive drool saliva and 10 minute filter paper saliva (one sample each from tongue and palate) collected in a fixed sequence of tastant flavors (same for each session) and the assigned test beverage intervention (different for each session)
次要结局
- Salivary pH(Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day)
- Saliva carbonic anhydrase concentration(Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day)
- Saliva total protein concentration(Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day)
- Saliva mucin 5B concentration Saliva mucin 5B concentration(Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day)
- Saliva mucin 7 concentration(Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day)
- Taste perceptions(Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day.)
- Beverage liking(Sequence of repeated sampling over 2 hours on each of 6 test days with a different beverage and the same tastants each test day)
- Adverse Events(Symptoms reported at each test day and between visits from Screening to test day six)