Liking Adaptation to Beverages With Varying Sweetness Levels After Prolonged Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Sweetness liking
研究概览
简要总结
This is a double-blind, controlled, parallel, randomized sensory study. The study will consist of two cohorts; habitual regular full-calorie Carbonated Soft Drink (CSD) consumers and habitual low-calorie CSD consumers. Each cohort will be randomized to one of 3 interventions for six months (24 weeks):
- Intervention 1: Control (full sweetness) beverage
- Intervention 2: Step-wise sweetness reduction series of beverages
- Intervention 3: Moderate sweetness (reduced sweetness) beverage
The primary outcome is to assess the perception changes in sweetness (magnitude scale) and sweetness liking (Likert scale) of a test product and a control product over a period of six months. The study endeavors to explore whether consumers of sweetened carbonated beverages can adapt liking to lower sweetness beverages after prolonged exposure of daily consumption of beverages with step-wise reduction of sweetness, or maintenance at reduced (moderate) sweetness.
Additional analysis will be to assess dietary compensation for sweetness in the step-wise and moderate reduction arms compared to the control arms (the full calorie and low calorie control beverages). Dietary analysis of calories and intakes of total sugar, added sugar, and servings of low-/non-calorie sweeteners will be assessed using a 3-day diet record pre-intervention and monthly for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Same packaging for all (cans). Color and flavor matched.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 25-55 years of age
- •Habitually consume regular or diet CSD
- •Willing and able to consume at least one orange CSD beverage daily for a total of 6 months and abstain from other sweetened beverages
- •Willing and able to complete questionnaires regarding dietary intake and sensory perception
- •Has internet access via computer, phone or other device and is able to maintain internet access throughout the trial in order to complete daily online questionnaires
- •Participant is judged to be in good health based on a verbal health query and the general health and lifestyle questionnaire
- •Participant is willing to maintain his or her habitual diet, smoking habits and physical activity patterns, including habitual use of study approved medications and/or dietary supplements throughout the study period
- •Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators
排除标准
- •Regular smoker (more than 1 cigarette per week)
- •History or presence of type 1 or 2 diabetes mellitus
- •Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic, and intermittent fasting (defined as intentional fasting for longer than 16 hours or alternate day fasting)
- •Extreme changes to physical activity
- •Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period
- •Recent history (within 12 months of screening; Visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits)
- •Individual has a condition the Clinical Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the participant at undue risk
- •Dislike of citrus flavored CSDs
- •Participation in another clinical trial within past 30 days
- •People who have phenylketonuria (low calorie sweetened beverages contain aspartame)
结局指标
主要结局
Sweetness liking
时间窗: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6
Likert Scale, 9 point scale from 1=Dislike extremely to 9=Like extremely
Sweetness intensity perception
时间窗: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6
Magnitude scale ranging from Barely perceptible to Strongest imaginable sweetness
次要结局
未报告次要终点